The effect of remote programming on deep brain stimulation in Parkinson’s disease: a retrospective study

The effect of remote programming on deep brain stimulation in Parkinson’s disease: a retrospective study | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Article The effect of remote programming on deep brain stimulation in Parkinson’s disease: a retrospective study Dianyou Li, Xiaonan Wan, Chengcheng Duan, Zhengyu Lin, Zhitong Zeng, and 1 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-3383913/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract For Parkinson’s disease (PD) patients undergoing deep brain stimulation (DBS), remote programming (RP) was developed to eliminate the burden of repeat office visits for standard programming (SP) sessions to maximize the treatment effect. No studies comparing the treatment effects of RP with SP directly were performed. Thirty-two propensity score matched patients were retrospectively recruited and allocated to the RP or SP group according to their programming methods, and clinical outcomes were compared at ~12-month follow-ups between the two groups. No differences were found in changes of the Unified PD Rating Scale III score, PD Questionnaire-8 score, or levodopa equivalent daily dose between the groups (p>0.05); and the average cost of the RP group decreased compared with their SP sessions (p<0.001), and was less than the average cost of the SP group (p=0.040), even though the patients in the RP group reside further from our center than patients in the SP group (p=0.004). This study demonstrated RP alleviates the cost burden of the short-term follow-ups for PD patients without compromising the DBS treatment effect. Health sciences/Health care/Health services/Rehabilitation Health sciences/Neurology/Neurological disorders/Movement disorders/Parkinsons disease Figures Figure 1 Figure 2 Introduction Deep brain stimulation (DBS) is a high-level evidence-based treatment for Parkinson’s disease (PD) [ 1 ], from which the optimal improvement in symptoms is usually achieved within four to five in-person parameter adjustment (programming) sessions of the implantable pulse generator (IPG) after surgery [ 2 ]. Long-term follow-ups are also necessary to monitor and treat stimulation-induced side effects or worsening symptoms [ 3 ]. Hence, travel between the patients’ residence and specialized centers for DBS parameter adjustment have become a nonnegligible burden on both patients and their caregivers, and the travel cost could increase over time due to the neurodegenerative nature of PD [ 4 ]. Remote programming (RP) is a novel technology allowing clinicians to observe patients through a video conference and make corresponding adjustment of medication and stimulation settings [ 5 ]. Its first application was recorded in 2015 and rapidly increased to 10,507 RP sessions annually in 2021 in China [ 6 ]. Compared with standard programming (SP) sessions, RP improves the workflow of follow-up and reduces the burden on both patients and their caregivers. The satisfaction and safety of RP has been confirmed by previous studies [ 7 – 9 ]; however, no studies comparing the treatment effect of RP with SP directly have been performed. In the current study, we conducted a retrospective analysis to compare the treatment effects of RP with SP on PD patients with DBS implantation who had received RP + SP or SP therapy only, and short-term improvement of motor symptoms was chosen as the primary outcome. Methods Participants All participants assessed for eligibility in this study were selected from the database of our center and had MDS UPDRS III scores. Patients who had undergone bilateral STN DBS in Ruijin Hospital between January 1, 2018 and December 31, 2022 were retrospectively recruited, and 32 patients were placed in two cohorts using PSM (Fig. 1 ). The inclusion criteria for this study were as follows: (1) age under 75 years old; (2) MDS UPDRS-III scores were recorded before and after surgery (more than 9 months); and (3) before the LFU, a) all programming sessions were completed through SP (these patients were assigned to the SP group) or, b) more than 60% of programming sessions were completed through RP (patients were assigned to the RP group). Data collection Videos of UPDRS-III and other assessments were recorded at baseline (as levodopa challenge test [ 10 ] ) and the LFU (with medication OFF/ DBS ON) [ 11 ]. The UPDRS-III score was assessed by two raters unaware of the study assignment. LEDD, PDQ-8, and TUQ were also analyzed at the LFU. In the LEDD, a higher score represents a higher dose of medication intake [ 11 ]. In the PDQ-8, a higher score represents a worse quality of life [ 12 ]), and in the TUQ, a higher score represents more agreement with the usability of telehealth [ 13 ]). We also surveyed caregivers to assess their burden at each session and the reasons why patients in the SP group refused to use the RP system through questionnaires. Detailed information about programming sessions and patients’ demographic data were retrieved from the RP systems (App, PINS “JiayiYoupin” patient version/ App, Sceneray “Jingyun Internet Hospital” patent control) and the Electronic Medical Record System in Ruijin Hospital. Written informed consent for the research was obtained before surgery. The study protocol was reviewed by the local Institutional Review Board and is in accordance with the Declaration of Helsinki. Costs analysis To analyze the costs for patients in both groups, a cost model was made (Supplement: Table 1 ), including the following components: (1) transportation (focusing on the fare for train and taxi); (2) the income loss for the time spent (collected through questionnaires) for each in-patient visit; (3) fee for each RP and SP session. Table 1 Characteristics of the population in this study. Characteristics RP (n = 16) SP before PSM (n = 26) p Value SP after PSM (n = 16) p Value Age (yr) 64.0 (54.0–67.0) 64.0 (60.0–69.0) 0.371 63.5 (58.5–68.5) 0.655 Sex, n (%) 0.636 1.000 - Male 11 (68.7%) 16 12 (75%) - Female 5 (31.3%) 10 4 (25%) Duration of PD (yr) 9.0 (6.5–13.5) 9.5 (6.0–13.0) 0.852 9.5 (7.0-13.5) 0.817 Follow-up interval (month) 14.0 (11.0-14.5) 13.0 (12.0–16.0) 0.725 13.0 (12.0–16.0) 0.512 LCT (%) UPDRS III, without medication PDQ-8 LEDD (mg/d) 52.7 (43.5–57.7) 52.5 (47.0–65.0) 11.0 (8.0–19.0) 712.5 (512.5–900.0) 46.3 (34.8–53.7) 59.0 (47.0–64.0) 12.0 (7.0–15.0) 600.0 (450.0-850.0) 0.147 0.671 0.564 0.775 47.4 (30.7–58.9) 60.5 (51.0-65.5) 14.0 (11.0–20.0) 587.5 (425.0-875.0) 0.167 0.577 0.586 0.707 Values are median (IQR: P25, P75) or n (%). Abbreviation: LCT, levodopa challenge test; LEDD, levodopa equivalent daily dose; PD, Parkinson’s disease; PDQ-8, 8-item version of the Parkinson’s Disease Questionnaire; PSM, propensity score matching; RP, remote programming; SP, standard programming; UPDRS III, MDS-Unified Parkinson’s Disease Rating Scale Part III. Propensity score matching PSM was conducted with the following parameters: nearest-neighbor matching in a 1:1 ratio; a caliper of 0.03; and covariates of sex and age at surgery. Matching quality was evaluated by comparing baseline characteristics as well as graphically inspecting the propensity scores between the two groups. Programming schedule In our center, IPG is regularly initiated with a narrow bipolar stimulation as “temporary stimulation” one day before discharge. We start the initial programming according to the results of the post-operative co-registered computed tomography (CT) scan one month after implantation when local edema has minimized. The configuration of contact and parameters are chosen when the most satisfactory motor effects are achieved with the fewest adverse effects. After initial programming, patients are then recommended to reprogram for optimized settings within 3 to 6 months over 4 to 5 sessions [ 2 ]. The method of each programming session (RP or SP) is totally decided by the patients according to their preferences. Remote programming procedure[ 14 , 15 ] When the agreed time is reached, the physician invites the patient to enter the online meeting room. After connecting to the patient’s IPG, the physician checks contact impedance and battery life at first and electrode position by the fusion of post-operative CT and pre-operative magnetic resonance imaging (MRI) scan. Subsequently, the doctor guides the patient to complete a series of specified actions and adjusts the patient’s parameters based on their electrode position and movement performance. Tremor or bradykinesia were chosen as the major clinical features, and gait was evaluated at the end. After new parameters were set, the physician enables the patient’s ability to adjust their voltages within a range, and the previous set of parameters (if they change) are saved to facilitate a rapid switch in the event of unbearable stimulation-induced side effects. Owing to the limitation of the RP systems for physicians to prescribe, medication adjustments are completed as suggestions. Statistical analysis We used an arbitrary cut-off of p > 0.05 as the margin for noninferiority due to the lack of former trials. Measurements are expressed as median (P25–P75). Intergroup comparisons of categorical data were performed using Fisher’s exact test, and comparisons of continuous variables were performed using the t-test or Wilcoxon rank-sum test depending on the distribution (no prior power calculation). To account for the matched design in the propensity score–matched sample, UPDRS III and LEDD were regarded as related samples and compared by paired t-test. Statistical analyses were performed using SAS 9.4 (SAS Institute Inc, Cary, NC, USA). All tests were two-sided, and p < 0.05 was considered statistically significant. Results Characteristics of the population A total of 32 patients were enrolled, 16 patients were allocated to the RP group and 16 propensity score matched (PSM) patients to the SP group (Fig. 1 ). The groups were balanced with respect to baseline characteristics (Table 1 ). The Unified Parkinson’s Disease Rating Scale Part III (UPDRS III) was collected in all patients, PDQ-8 and LEDD was collected in 18 and 30 patients, respectively. Motor and other clinical outcomes A significant difference was observed between the two groups in UPDRS III score (p < 0.001 in both groups), 8-item version of the Parkinson’s Disease Questionnaire (PDQ-8; p = 0.018 in the RP group, p = 0.034 in the SP group), and levodopa equivalent daily dose (LEDD; p < 0.001 in both groups; Fig. 2 ) between the baseline and last follow-up (LFU). No statical significance was found in all clinical outcomes at LFU between the RP and SP groups. The median UPDRS III was 27.0 (IQR: 24.0–37.5) in the RP group compared with 37.0 (IQR: 25.5–43.5) in the SP group (p = 0.409; Fig. 2 A); the median PDQ-8 was 6.0 (IQR: 4.0–10.0) in the RP group compared with 7.0 (IQR: 6.0–12.0) in the SP group (p = 0.495; Fig. 2 B); and the median LEDD was 400.0 (IQR: 312.5–425.0) in the RP group compared with 339.3 (IQR: 200.0–425.0) in the SP group (p = 0.269; Fig. 2 C). The improvement in clinical outcomes mentioned above (UPRS III, PDQ-8, and LEDD), reflected by change from baseline to LFU, was not different between the groups; for sub-scores of UPDRS III in rigidity, tremor, bradykinesia, and axial symptoms, there were also no differences (Supplement: Table 2 ). Table 2 Stimulation settings in two groups. parameter RP (n = 16) SP (n = 14) p Value Voltage (V) 3.3 (2.9–3.5) 3.2 (2.7–3.5) 0.630 Frequency (Hz) 115.0 (60.0-145.0) 117.5 (90.0-145.0) 0.381 -Low frequency, n (%) 5 (31.3%) 2 (14.3%) 0.507 Pulse width (µs) 50.0 (50.0–60.0) 60 (60.0–70.0) 0.033* − 30µs short pulse, n (%) 2 (12.5%) 2 (14.3%) 1.000 Interleaving stimulation, n (%) 14 (87.5%) 10 (71.4%) 0.522 Values are median (IQR: P25, P75) or n (%). Abbreviations: RP, remote programming; SP, standard programming. *p < 0.05 No severe adverse events or complications were recorded in both groups except for several IPG replacements in SP group. Stimulation settings The stimulation settings of 30 patients were analyzed (Table 2 ). The voltage and frequency were not significantly different between the two groups. The median pulse width of the RP group was 50.0 (IQR: 50.0–60.0), which was shorter than 60 (IQR: 60.0–70.0) observed in the SP group (p = 0.033). No significant differences were observed in the proportion of “low frequency,” “short pulse,” or “interleaving stimulation” between both groups. Costs Table 3 summarizes the number of programming sessions (RP/SP) and the cost of the two arms. There was a significant difference in average cost per session between the RP and SP groups. Although patients in the RP group lived further from the clinic site than those in the SP group (p = 0.004), the median average cost was 368.8 (IQR: 205.7–488.7) RMB in the RP group, lower than 574.8 (IQR: 295.1–906.5) RMB in the SP group (p = 0.040; Table 2 ). This was also much lower than the cost for each in-person session by patients in the RP group (1140.1 [IQR: 946.9-1558.7] RMB, p < 0.001; Supplement: Fig. 1 A.). Table 3 Cost analysis of two groups during the study. Cost RP (n = 16) SP (n = 16) p Value Remote programming 5.5 (3.5–18.5) 0 < 0.001* Standard programming 1.0 (0.5-2.0) 4.5 (3.0-6.5) 0.001* Total sessions 5.5 (4.0-18.5) 4.5 (3.0-6.5) 0.237 Distance (km) 423.0 (164.5–497.0) 30.9 (14.3–164.0) 0.004* Average cost per session (RMB) 368.8 (205.7-488.7) 574.8 (295.1-906.5) 0.040* Total costs (RMB) 1897.2 (1100.0-2995.5) 2222.7 (1757.4-3448.5) 0.534 Values are median (IQR: P25, P75) or n (%). Abbreviation: RMB, Renminbi; RP, remote programming; SP, standard programming. *p < 0.05 No significance was found in the total number of programming sessions between the two groups. The median number of sessions was 5.5 (IQR: 4.0–18.5) in the RP group and 4.5 (IQR: 3.0-6.5) in the SP group (p = 0.237; Table 2 ), and the mean duration of each RP session was 26.4 min. Burden of caregivers and patients’ attitude In total, 28 patients reported the burden of their caregivers for each programming session. For each in-clinic session, no significant difference was found between the two groups in the OFF-work days or number of caregivers (Supplement: Fig. 1 B and 1 C); in the RP group, the median of OFF-work days was 0 for RP sessions, less than 1.0 (IQR: 0–1.0) for SP sessions (p < 0.001; Supplement: Fig. 1 C). Twelve of sixteen patients in the RP group completed the Telehealth Usability Questionnaire (TUQ) (Supplement: Fig. 2 ), and seven out of sixteen in the SP group reported their attitude regarding RP (Supplement: Fig. 3). According to the results of the TUQ, most features of the RP system were amenable to patients except for some items (with relatively lower scores, including a. “Telehealth provides for my healthcare need.”; b. “This system is able to do everything I would want it to be able to do.”; c. “Using the telehealth system, I can see the clinician as well as if we met in person.”; and d. “I think the visits provided over the telehealth system are the same as in-person visits.”). For seven patients who had given up the RP function on their IPGs, unfamiliarity with the RP system was the major reason for their insistence on in-person visits. Discussion The main aim of this retrospective control study was to compare the treatment effect of RP with SP on daily management of PD patients with DBS implantation. Two PSM cohorts were compared, and the following results were obtained: 1. RP achieved clinical benefits that were not inferior to SP in post-operative management of PD patients with DBS implants; 2. RP reduced the economic burden of patients after surgery, without reducing the number of caregivers required for each program session; 3. Although the RP system was generally reported as satisfactory by the patients, the satisfaction at the domain of interaction and reality is slightly poor. The results of this study provide evidence for the application of remote RP in the field of post-operative management of DBS. RP was developed to alleviate the burden caused by repeated visits to experienced physicians for maximum treatment effect of DBS; the safety, feasibility, and effectiveness have already been proven [ 8 , 9 , 16 ]. No difference was found between the two groups in UPDRS III score or its sub-scores, suggesting this new interface method allows physicians to adjust patients’ IPG without compromising the effect of DBS on PD patients in the short term. Most patients gained a significant improvement of quality of life and medication intake. The percent change of the RP vs SP group from baseline to 12 months in PDQ-8 and LEDD were 30% vs 35% and 40% vs 50%, respectively, in line with previous studies [ 17 , 18 ]. Chen et al. [ 7 ] reported medication adjustments could be more conservative in the RP group. The decrease of LEDD of the RP group was also lower in our study but without statistical difference, perhaps due to treatment variations among physicians. Compared with SP, RP was considered more flexible in time and space with higher cost-effectiveness. In the current study, the RP group lived significantly farther away from the clinic than the SP group, but the total cost was not significantly higher than that of the SP group, and the average cost of each session was even lower than that of the SP group. In China, the fee of each RP is now set by physicians, which is usually lower than travel cost especially for those outside the area of our center or with mobility issues. For caregivers of PD patients with DBS, the advantage of RP is mainly reflected in the time savings benefit from the flexibility, rather than reducing the number of caregivers. The internet-based appointment eliminates geographical limitations, improves the workflow of medical service, and saves waiting time for both physicians and patients. In this study, the mean duration of each RP session was 26.4 min, higher than the average time of outpatient service in China (15.3 min, p = 0.016; [ 19 ]); The average age of the patients in this study was 60.5 years old, and some of them are not familiar with smart phones, which makes it necessary for a caregiver to assist during almost each RP programming period. In our center, RP training is provided for both patients and specific caregivers before discharge. In addition, the RP of DBS involves many steps (including the connection between the patients’ controller and the IPG, the connection between the patients’ controller and internet devices, the connection between physicians’ computer and the internet, etc.). Smooth network, proficient operation, and the patient’s environment could be factors affecting the overall RP experience and treatment effect. In the SP group, the main reason for giving up the RP function on their IPG was the difficulty in mastering the RP system; in the RP group, although the system was generally satisfactory, agreement of the interaction and reality is slightly poor. Perhaps the friendliness of the operation interface and training for patients and their caregivers are key factors in promoting RP in the PD DBS community in the future. There was no significant difference in the number of programming sessions between the two groups, but three patients in the RP group had many more RP sessions (21, 16, 42 times; mild outliers) than the average number (median: 5.5 [IQR: 3.5–18.5]). This may be the result of their subjective perception of poor symptom control, although their U3 improvement was not worse than the average level (31%, 64%, 45%). The convenient access to physicians that RP provided could increase the requests for programming. Zhang et al. [ 14 ] reported an increasing number of programming sessions after the lock-down measures of COVID-19, and 52 out of 909 RP sessions without DBS adjustments were mostly reported to be satisfactory, suggesting the demand for RP would increase as the patients gradually become familiar with RP and the satisfaction was not only associated with DBS itself, but also with their expectations and the psychological support or medical consults during each RP session. We compared the stimulation settings between the two groups, and no significance was found in the voltage and frequency, but the pulse width was shorter in the RP group, in accordance with a previous study [ 7 ]. A short pulse width below 60 µs could increase the threshold for side effects by avoiding activation of adjacent tissue and widening the therapeutic window [ 20 , 21 ], which was used in the titration of voltage/current in the RP programming sessions through fine-tune adjustment. A pulse width of 30 µs was reported to improve gait and speech and to avoid stimulation-induced adverse effects [ 22 , 23 ], but these benefits were controversial as they failed to be replicated by randomized, double-blind studies [ 24 , 25 ]. In the RP group, while most patients finished their initial programming through the traditional in-person method, 4 individuals finished all programming sessions by RP. Initial programming required more detailed parameter titration than reprogramming [ 3 ]. No criteria for initial remote programming of DBS in PD has been established yet, and according to our current practice, initial programming by RP may be more suitable for those traveling long distances, with higher levels of caregiver cooperation and cognitive abilities, but the safety and feasibility of RP in initial programming are still to be confirmed by further research. This study has several limitations that need to be acknowledged. First, due to the retrospective nature of this study, only associations among variables could be drawn instead of casual relationships; for example, travel cost differed significantly between the two groups, but it is a factor that affects patients’ attitudes toward the programming method. Second, this is a single-center study; therefore, it remains uncertain whether the results can be generalized to other hospitals. For example, the experience levels of the programming physicians affect the programming frequency and the choice of programming model. Third, we followed up for a relatively short period. In the long term, DBS provides stable improvements of most motor symptoms except for axial symptoms (i.e., gait and balance symptoms, speech, and swallowing difficulty) and cognitive decline [ 26 ]. For those experiencing troublesome axial symptoms, multiple attempts and observations to obtain optimal stimulation are still recommended [ 3 , 7 ]. In the future, we intend to conduct prospective studies with larger sample sizes to further validate the effect of RP on more clinical outcomes and explore its benefits for different populations. Conclusion This 12-month retrospective study demonstrated that compared with standard programming, remote programming conferred non-inferior improvements in motor symptoms for PD patients with subthalamic nucleus (STN) DBS and alleviated the burden of cost for those who live far from specialized centers for short-term follow-ups. The effect of treatment and flexibility in time of RP are the key to achieving personalized post-operative DBS management more easily. Declarations Data Availability The datasets used and/or analyzed during the current study available from the corresponding author on reasonable request. Acknowledgements We would like to thank all participants for partaking in the study. Author Contributions Conception and design: D Li. Acquisition of data: C Zhang. Analysis and interpretation of data: X Wan, C Duan. Drafting the article: X Wan, C Duan. Critically revising the article: Z Lin, Z Zeng. Reviewed submitted version of manuscript: all authors. Approved the final version of the manuscript on behalf of all authors: D Li. Administrative/technical/material support: C Zhang. Competing Interests statement Dianyou Li was funded by the National Natural Science Foundation of China [Grant 81971294 to DL] and the Shanghai Science and Technology Commission International Cooperation Project [Grant 20410712000 to DL]. The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. References Schuepbach, W.M., et al., Neurostimulation for Parkinson's disease with early motor complications. N Engl J Med, 2013. 368 (7): p. 610-22. Bronstein, J.M., et al., Deep brain stimulation for Parkinson disease: an expert consensus and review of key issues. Arch Neurol, 2011. 68 (2): p. 165. Picillo, M., et al., Programming Deep Brain Stimulation for Parkinson's Disease: The Toronto Western Hospital Algorithms. 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Petry-Schmelzer, J.N., et al., A Randomized, Double-Blinded Crossover Trial of Short Versus Conventional Pulse Width Subthalamic Deep Brain Stimulation in Parkinson's Disease. J Parkinsons Dis, 2022. 12 (5): p. 1497-1505. Limousin, P. and T. Foltynie, Long-term outcomes of deep brain stimulation in Parkinson disease. Nat Rev Neurol, 2019. 15 (4): p. 234-242. Additional Declarations No competing interests reported. Supplementary Files Supplement.docx Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-3383913","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Article","associatedPublications":[],"authors":[{"id":236119369,"identity":"88cd6300-051e-4c4a-ac79-e30934a33ba9","order_by":0,"name":"Dianyou Li","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA1ElEQVRIiWNgGAWjYBACPoYEhgMJPDZ2/AwMacRpYWNIYDzwQCYtWbKBBC3MBx/YHGbccADIJk4Le47BgYScNGbj2weePWCosYlmYD97AL8WnjdALWds+MzOJaQbMBxLy23gyUvAr0UCaEtiTxqz2RmGNAnGhsO5DRI8BkRo+XeYcXMPSVoSeIDe5yFaC8+zAqCWtGQJkMMSgH5p48nBr4WfPXnzxx+gqOzhSZP4UGOT289+Br8WBgYOmAKeBGBKYCAmdtgfwBgHCCseBaNgFIyCEQkAC4ZEQtrmprAAAAAASUVORK5CYII=","orcid":"","institution":"Department of Neurosurgery, Center for Functional Neurosurgery, Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China.","correspondingAuthor":true,"submittingAuthor":false,"prefix":"","firstName":"Dianyou","middleName":"","lastName":"Li","suffix":""},{"id":236119370,"identity":"35e13082-4874-424f-841b-970850564bfb","order_by":1,"name":"Xiaonan Wan","email":"","orcid":"","institution":"Department of Neurosurgery, Center for Functional Neurosurgery, Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China.","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Xiaonan","middleName":"","lastName":"Wan","suffix":""},{"id":236119371,"identity":"1ba25885-e4c2-40ce-9393-21e4f95a48c9","order_by":2,"name":"Chengcheng Duan","email":"","orcid":"","institution":"Department of Neurosurgery, Center for Functional Neurosurgery, Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China.","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Chengcheng","middleName":"","lastName":"Duan","suffix":""},{"id":236119372,"identity":"ccea957b-a47b-4eee-9369-ad09eb3ff2bd","order_by":3,"name":"Zhengyu Lin","email":"","orcid":"","institution":"Department of Neurosurgery, Center for Functional Neurosurgery, Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China.","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Zhengyu","middleName":"","lastName":"Lin","suffix":""},{"id":236119373,"identity":"70cccc70-0f45-48b6-9471-4f2214948c38","order_by":4,"name":"Zhitong Zeng","email":"","orcid":"","institution":"Department of Neurosurgery, Center for Functional Neurosurgery, Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China.","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Zhitong","middleName":"","lastName":"Zeng","suffix":""},{"id":236119375,"identity":"c1c71cfd-64b6-4185-a04d-4c63be717b92","order_by":5,"name":"Chencheng Zhang","email":"","orcid":"","institution":"Clinical Neuroscience Center, Ruijin Hospital Luwan Branch, Shanghai Jiao Tong University School of Medicine","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Chencheng","middleName":"","lastName":"Zhang","suffix":""}],"badges":[],"createdAt":"2023-09-25 08:44:29","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-3383913/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-3383913/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":44044402,"identity":"c8b5ed11-ab8b-41a2-a43d-38927de7327a","added_by":"auto","created_at":"2023-10-03 22:40:43","extension":"jpg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":53490,"visible":true,"origin":"","legend":"\u003cp\u003eParticipant flow of this study. Propensity score matching was conducted with sex and age as covariates at a 1:1 ratio.\u003c/p\u003e\n\u003cp\u003eAbbreviation: DBS; deep brain stimulation; RP, remote programming; SP, standard programming; STN, subthalamic nucleus; UPDRS III, MDS-Unified Parkinson’s Disease Rating Scale Part III.\u003c/p\u003e","description":"","filename":"1.jpg","url":"https://assets-eu.researchsquare.com/files/rs-3383913/v1/91d13ae9edd40e1d6e75b88f.jpg"},{"id":44044401,"identity":"19f7536d-d17c-4d0b-954c-12a0025f0948","added_by":"auto","created_at":"2023-10-03 22:40:43","extension":"jpg","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":44909,"visible":true,"origin":"","legend":"\u003cp\u003eClinical outcomes for the Remote Programming (RP) group and the Standard Programming (SP) group. A) UPDRS III scores, videos were recorded without medication. B) PDQ-8 scores. C) LEDD. Boxes represent the medians and whiskers represent the range of data.\u003c/p\u003e\n\u003cp\u003eAbbreviations: LEDD, levodopa equivalent daily dose; PDQ-8, 8-item version of the Parkinson’s Disease Questionnaire; UPDRS III, MDS-Unified Parkinson’s Disease Rating Scale Part III.\u003c/p\u003e","description":"","filename":"2.jpg","url":"https://assets-eu.researchsquare.com/files/rs-3383913/v1/d4118dc81a674481e03e1f96.jpg"},{"id":45429703,"identity":"a21514c9-8171-40c4-a982-09e35d5bba31","added_by":"auto","created_at":"2023-10-30 07:52:29","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":402952,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-3383913/v1/fcb38bfe-ac82-447e-8f68-e3840a79b60d.pdf"},{"id":44044403,"identity":"f751984e-892c-43ba-80a5-4f0f38279680","added_by":"auto","created_at":"2023-10-03 22:40:44","extension":"docx","order_by":2,"title":"","display":"","copyAsset":false,"role":"supplement","size":258321,"visible":true,"origin":"","legend":"","description":"","filename":"Supplement.docx","url":"https://assets-eu.researchsquare.com/files/rs-3383913/v1/db7f59f23525df879e6298ae.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"The effect of remote programming on deep brain stimulation in Parkinson’s disease: a retrospective study","fulltext":[{"header":"Introduction","content":"\u003cp\u003eDeep brain stimulation (DBS) is a high-level evidence-based treatment for Parkinson\u0026rsquo;s disease (PD) [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e], from which the optimal improvement in symptoms is usually achieved within four to five in-person parameter adjustment (programming) sessions of the implantable pulse generator (IPG) after surgery [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]. Long-term follow-ups are also necessary to monitor and treat stimulation-induced side effects or worsening symptoms [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]. Hence, travel between the patients\u0026rsquo; residence and specialized centers for DBS parameter adjustment have become a nonnegligible burden on both patients and their caregivers, and the travel cost could increase over time due to the neurodegenerative nature of PD [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eRemote programming (RP) is a novel technology allowing clinicians to observe patients through a video conference and make corresponding adjustment of medication and stimulation settings [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. Its first application was recorded in 2015 and rapidly increased to 10,507 RP sessions annually in 2021 in China [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. Compared with standard programming (SP) sessions, RP improves the workflow of follow-up and reduces the burden on both patients and their caregivers. The satisfaction and safety of RP has been confirmed by previous studies [\u003cspan additionalcitationids=\"CR8\" citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]; however, no studies comparing the treatment effect of RP with SP directly have been performed.\u003c/p\u003e \u003cp\u003eIn the current study, we conducted a retrospective analysis to compare the treatment effects of RP with SP on PD patients with DBS implantation who had received RP\u0026thinsp;+\u0026thinsp;SP or SP therapy only, and short-term improvement of motor symptoms was chosen as the primary outcome.\u003c/p\u003e "},{"header":"Methods","content":"\n\u003ch3\u003eParticipants\u003c/h3\u003e\n\u003cp\u003eAll participants assessed for eligibility in this study were selected from the database of our center and had MDS UPDRS III scores. Patients who had undergone bilateral STN DBS in Ruijin Hospital between January 1, 2018 and December 31, 2022 were retrospectively recruited, and 32 patients were placed in two cohorts using PSM (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). The inclusion criteria for this study were as follows: (1) age under 75 years old; (2) MDS UPDRS-III scores were recorded before and after surgery (more than 9 months); and (3) before the LFU, a) all programming sessions were completed through SP (these patients were assigned to the SP group) or, b) more than 60% of programming sessions were completed through RP (patients were assigned to the RP group).\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eData collection\u003c/h2\u003e \u003cp\u003eVideos of UPDRS-III and other assessments were recorded at baseline (as levodopa challenge test [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e] ) and the LFU (with medication OFF/ DBS ON) [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]. The UPDRS-III score was assessed by two raters unaware of the study assignment.\u003c/p\u003e \u003cp\u003eLEDD, PDQ-8, and TUQ were also analyzed at the LFU. In the LEDD, a higher score represents a higher dose of medication intake [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]. In the PDQ-8, a higher score represents a worse quality of life [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]), and in the TUQ, a higher score represents more agreement with the usability of telehealth [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]). We also surveyed caregivers to assess their burden at each session and the reasons why patients in the SP group refused to use the RP system through questionnaires.\u003c/p\u003e \u003cp\u003eDetailed information about programming sessions and patients\u0026rsquo; demographic data were retrieved from the RP systems (App, PINS \u0026ldquo;JiayiYoupin\u0026rdquo; patient version/ App, Sceneray \u0026ldquo;Jingyun Internet Hospital\u0026rdquo; patent control) and the Electronic Medical Record System in Ruijin Hospital.\u003c/p\u003e \u003cp\u003e Written informed consent for the research was obtained before surgery. The study protocol was reviewed by the local Institutional Review Board and is in accordance with the Declaration of Helsinki.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003eCosts analysis\u003c/h2\u003e \u003cp\u003eTo analyze the costs for patients in both groups, a cost model was made (Supplement: Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e), including the following components: (1) transportation (focusing on the fare for train and taxi); (2) the income loss for the time spent (collected through questionnaires) for each in-patient visit; (3) fee for each RP and SP session.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eCharacteristics of the population in this study.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"6\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCharacteristics\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eRP\u003c/p\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;16)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eSP before PSM\u003c/p\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;26)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u003cem\u003ep\u003c/em\u003e Value\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eSP after PSM\u003c/p\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;16)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003e\u003cem\u003ep\u003c/em\u003e Value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAge (yr)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e64.0 (54.0\u0026ndash;67.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e64.0 (60.0\u0026ndash;69.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.371\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e63.5 (58.5\u0026ndash;68.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e0.655\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSex, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.636\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e1.000\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e- Male\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e11 (68.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e16\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e12 (75%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e- Female\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e5 (31.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e10\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e4 (25%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDuration of PD (yr)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e9.0 (6.5\u0026ndash;13.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e9.5 (6.0\u0026ndash;13.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.852\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e9.5 (7.0-13.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e0.817\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFollow-up interval (month)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e14.0 (11.0-14.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e13.0 (12.0\u0026ndash;16.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.725\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e13.0 (12.0\u0026ndash;16.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e0.512\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eLCT (%)\u003c/p\u003e \u003cp\u003eUPDRS III, without medication\u003c/p\u003e \u003cp\u003ePDQ-8\u003c/p\u003e \u003cp\u003eLEDD (mg/d)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e52.7 (43.5\u0026ndash;57.7)\u003c/p\u003e \u003cp\u003e52.5 (47.0\u0026ndash;65.0)\u003c/p\u003e \u003cp\u003e11.0 (8.0\u0026ndash;19.0)\u003c/p\u003e \u003cp\u003e712.5 (512.5\u0026ndash;900.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e46.3 (34.8\u0026ndash;53.7)\u003c/p\u003e \u003cp\u003e59.0 (47.0\u0026ndash;64.0)\u003c/p\u003e \u003cp\u003e12.0 (7.0\u0026ndash;15.0)\u003c/p\u003e \u003cp\u003e600.0 (450.0-850.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.147\u003c/p\u003e \u003cp\u003e0.671\u003c/p\u003e \u003cp\u003e0.564\u003c/p\u003e \u003cp\u003e0.775\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e47.4 (30.7\u0026ndash;58.9)\u003c/p\u003e \u003cp\u003e60.5 (51.0-65.5)\u003c/p\u003e \u003cp\u003e14.0 (11.0\u0026ndash;20.0)\u003c/p\u003e \u003cp\u003e587.5 (425.0-875.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e0.167\u003c/p\u003e \u003cp\u003e0.577\u003c/p\u003e \u003cp\u003e0.586\u003c/p\u003e \u003cp\u003e0.707\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"6\"\u003eValues are median (IQR: P25, P75) or n (%).\u003c/td\u003e\u003c/tr\u003e \u003ctr\u003e\u003ctd colspan=\"6\"\u003eAbbreviation: LCT, levodopa challenge test; LEDD, levodopa equivalent daily dose; PD, Parkinson\u0026rsquo;s disease; PDQ-8, 8-item version of the Parkinson\u0026rsquo;s Disease Questionnaire; PSM, propensity score matching; RP, remote programming; SP, standard programming; UPDRS III, MDS-Unified Parkinson\u0026rsquo;s Disease Rating Scale Part III.\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003ePropensity score matching\u003c/h2\u003e \u003cp\u003ePSM was conducted with the following parameters: nearest-neighbor matching in a 1:1 ratio; a caliper of 0.03; and covariates of sex and age at surgery. Matching quality was evaluated by comparing baseline characteristics as well as graphically inspecting the propensity scores between the two groups.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003eProgramming schedule\u003c/h2\u003e \u003cp\u003eIn our center, IPG is regularly initiated with a narrow bipolar stimulation as \u0026ldquo;temporary stimulation\u0026rdquo; one day before discharge. We start the initial programming according to the results of the post-operative co-registered computed tomography (CT) scan one month after implantation when local edema has minimized. The configuration of contact and parameters are chosen when the most satisfactory motor effects are achieved with the fewest adverse effects. After initial programming, patients are then recommended to reprogram for optimized settings within 3 to 6 months over 4 to 5 sessions [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]. The method of each programming session (RP or SP) is totally decided by the patients according to their preferences.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec7\" class=\"Section2\"\u003e \u003ch2\u003eRemote programming procedure[\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e, \u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]\u003c/h2\u003e \u003cp\u003eWhen the agreed time is reached, the physician invites the patient to enter the online meeting room. After connecting to the patient\u0026rsquo;s IPG, the physician checks contact impedance and battery life at first and electrode position by the fusion of post-operative CT and pre-operative magnetic resonance imaging (MRI) scan. Subsequently, the doctor guides the patient to complete a series of specified actions and adjusts the patient\u0026rsquo;s parameters based on their electrode position and movement performance. Tremor or bradykinesia were chosen as the major clinical features, and gait was evaluated at the end. After new parameters were set, the physician enables the patient\u0026rsquo;s ability to adjust their voltages within a range, and the previous set of parameters (if they change) are saved to facilitate a rapid switch in the event of unbearable stimulation-induced side effects.\u003c/p\u003e \u003cp\u003eOwing to the limitation of the RP systems for physicians to prescribe, medication adjustments are completed as suggestions.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003eStatistical analysis\u003c/h2\u003e \u003cp\u003eWe used an arbitrary cut-off of p\u0026thinsp;\u0026gt;\u0026thinsp;0.05 as the margin for noninferiority due to the lack of former trials. Measurements are expressed as median (P25\u0026ndash;P75). Intergroup comparisons of categorical data were performed using Fisher\u0026rsquo;s exact test, and comparisons of continuous variables were performed using the t-test or Wilcoxon rank-sum test depending on the distribution (no prior power calculation). To account for the matched design in the propensity score\u0026ndash;matched sample, UPDRS III and LEDD were regarded as related samples and compared by paired t-test. Statistical analyses were performed using SAS 9.4 (SAS Institute Inc, Cary, NC, USA). All tests were two-sided, and p\u0026thinsp;\u0026lt;\u0026thinsp;0.05 was considered statistically significant.\u003c/p\u003e \u003c/div\u003e"},{"header":"Results","content":"\u003cdiv id=\"Sec10\" class=\"Section2\"\u003e \u003ch2\u003eCharacteristics of the population\u003c/h2\u003e \u003cp\u003eA total of 32 patients were enrolled, 16 patients were allocated to the RP group and 16 propensity score matched (PSM) patients to the SP group (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). The groups were balanced with respect to baseline characteristics (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). The Unified Parkinson\u0026rsquo;s Disease Rating Scale Part III (UPDRS III) was collected in all patients, PDQ-8 and LEDD was collected in 18 and 30 patients, respectively.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003eMotor and other clinical outcomes\u003c/h2\u003e \u003cp\u003eA significant difference was observed between the two groups in UPDRS III score (p\u0026thinsp;\u0026lt;\u0026thinsp;0.001 in both groups), 8-item version of the Parkinson\u0026rsquo;s Disease Questionnaire (PDQ-8; p\u0026thinsp;=\u0026thinsp;0.018 in the RP group, p\u0026thinsp;=\u0026thinsp;0.034 in the SP group), and levodopa equivalent daily dose (LEDD; p\u0026thinsp;\u0026lt;\u0026thinsp;0.001 in both groups; Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e) between the baseline and last follow-up (LFU).\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eNo statical significance was found in all clinical outcomes at LFU between the RP and SP groups. The median UPDRS III was 27.0 (IQR: 24.0\u0026ndash;37.5) in the RP group compared with 37.0 (IQR: 25.5\u0026ndash;43.5) in the SP group (p\u0026thinsp;=\u0026thinsp;0.409; Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003eA); the median PDQ-8 was 6.0 (IQR: 4.0\u0026ndash;10.0) in the RP group compared with 7.0 (IQR: 6.0\u0026ndash;12.0) in the SP group (p\u0026thinsp;=\u0026thinsp;0.495; Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003eB); and the median LEDD was 400.0 (IQR: 312.5\u0026ndash;425.0) in the RP group compared with 339.3 (IQR: 200.0\u0026ndash;425.0) in the SP group (p\u0026thinsp;=\u0026thinsp;0.269; Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003eC).\u003c/p\u003e \u003cp\u003eThe improvement in clinical outcomes mentioned above (UPRS III, PDQ-8, and LEDD), reflected by change from baseline to LFU, was not different between the groups; for sub-scores of UPDRS III in rigidity, tremor, bradykinesia, and axial symptoms, there were also no differences (Supplement: Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eStimulation settings in two groups.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"4\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eparameter\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eRP (n\u0026thinsp;=\u0026thinsp;16)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eSP (n\u0026thinsp;=\u0026thinsp;14)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u003cem\u003ep\u003c/em\u003e Value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eVoltage (V)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e3.3 (2.9\u0026ndash;3.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e3.2 (2.7\u0026ndash;3.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.630\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFrequency (Hz)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e115.0 (60.0-145.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e117.5 (90.0-145.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.381\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e-Low frequency, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e5 (31.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e2 (14.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.507\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePulse width (\u0026micro;s)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e50.0 (50.0\u0026ndash;60.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e60 (60.0\u0026ndash;70.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.033*\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u0026minus;\u0026thinsp;30\u0026micro;s short pulse, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e2 (12.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e2 (14.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e1.000\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eInterleaving stimulation, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e14 (87.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e10 (71.4%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.522\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"4\"\u003eValues are median (IQR: P25, P75) or n (%). Abbreviations: RP, remote programming; SP, standard programming. *p\u0026thinsp;\u0026lt;\u0026thinsp;0.05\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eNo severe adverse events or complications were recorded in both groups except for several IPG replacements in SP group.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003eStimulation settings\u003c/h2\u003e \u003cp\u003eThe stimulation settings of 30 patients were analyzed (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e). The voltage and frequency were not significantly different between the two groups. The median pulse width of the RP group was 50.0 (IQR: 50.0\u0026ndash;60.0), which was shorter than 60 (IQR: 60.0\u0026ndash;70.0) observed in the SP group (p\u0026thinsp;=\u0026thinsp;0.033). No significant differences were observed in the proportion of \u0026ldquo;low frequency,\u0026rdquo; \u0026ldquo;short pulse,\u0026rdquo; or \u0026ldquo;interleaving stimulation\u0026rdquo; between both groups.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec13\" class=\"Section2\"\u003e \u003ch2\u003eCosts\u003c/h2\u003e \u003cp\u003eTable\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e summarizes the number of programming sessions (RP/SP) and the cost of the two arms. There was a significant difference in average cost per session between the RP and SP groups. Although patients in the RP group lived further from the clinic site than those in the SP group (p\u0026thinsp;=\u0026thinsp;0.004), the median average cost was 368.8 (IQR: 205.7\u0026ndash;488.7) RMB in the RP group, lower than 574.8 (IQR: 295.1\u0026ndash;906.5) RMB in the SP group (p\u0026thinsp;=\u0026thinsp;0.040; Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e). This was also much lower than the cost for each in-person session by patients in the RP group (1140.1 [IQR: 946.9-1558.7] RMB, p\u0026thinsp;\u0026lt;\u0026thinsp;0.001; Supplement: Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003eA.).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eCost analysis of two groups during the study.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"4\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCost\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eRP (n\u0026thinsp;=\u0026thinsp;16)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eSP (n\u0026thinsp;=\u0026thinsp;16)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u003cem\u003ep\u003c/em\u003e Value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eRemote programming\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e5.5 (3.5\u0026ndash;18.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.001*\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eStandard programming\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e1.0 (0.5-2.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4.5 (3.0-6.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.001*\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTotal sessions\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e5.5 (4.0-18.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4.5 (3.0-6.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.237\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDistance (km)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e423.0 (164.5\u0026ndash;497.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e30.9 (14.3\u0026ndash;164.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.004*\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAverage cost per session (RMB)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e368.8 (205.7-488.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e574.8 (295.1-906.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.040*\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTotal costs (RMB)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e1897.2 (1100.0-2995.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2222.7 (1757.4-3448.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.534\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"4\"\u003eValues are median (IQR: P25, P75) or n (%).\u003c/td\u003e\u003c/tr\u003e \u003ctr\u003e\u003ctd colspan=\"4\"\u003eAbbreviation: RMB, Renminbi; RP, remote programming; SP, standard programming.\u003c/td\u003e\u003c/tr\u003e \u003ctr\u003e\u003ctd colspan=\"4\"\u003e*p\u0026thinsp;\u0026lt;\u0026thinsp;0.05\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eNo significance was found in the total number of programming sessions between the two groups. The median number of sessions was 5.5 (IQR: 4.0\u0026ndash;18.5) in the RP group and 4.5 (IQR: 3.0-6.5) in the SP group (p\u0026thinsp;=\u0026thinsp;0.237; Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e), and the mean duration of each RP session was 26.4 min.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec14\" class=\"Section2\"\u003e \u003ch2\u003eBurden of caregivers and patients\u0026rsquo; attitude\u003c/h2\u003e \u003cp\u003eIn total, 28 patients reported the burden of their caregivers for each programming session. For each in-clinic session, no significant difference was found between the two groups in the OFF-work days or number of caregivers (Supplement: Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003eB and \u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003eC); in the RP group, the median of OFF-work days was 0 for RP sessions, less than 1.0 (IQR: 0\u0026ndash;1.0) for SP sessions (p\u0026thinsp;\u0026lt;\u0026thinsp;0.001; Supplement: Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003eC).\u003c/p\u003e \u003cp\u003eTwelve of sixteen patients in the RP group completed the Telehealth Usability Questionnaire (TUQ) (Supplement: Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e), and seven out of sixteen in the SP group reported their attitude regarding RP (Supplement: Fig.\u0026nbsp;3). According to the results of the TUQ, most features of the RP system were amenable to patients except for some items (with relatively lower scores, including a. \u0026ldquo;Telehealth provides for my healthcare need.\u0026rdquo;; b. \u0026ldquo;This system is able to do everything I would want it to be able to do.\u0026rdquo;; c. \u0026ldquo;Using the telehealth system, I can see the clinician as well as if we met in person.\u0026rdquo;; and d. \u0026ldquo;I think the visits provided over the telehealth system are the same as in-person visits.\u0026rdquo;). For seven patients who had given up the RP function on their IPGs, unfamiliarity with the RP system was the major reason for their insistence on in-person visits.\u003c/p\u003e \u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eThe main aim of this retrospective control study was to compare the treatment effect of RP with SP on daily management of PD patients with DBS implantation. Two PSM cohorts were compared, and the following results were obtained: 1. RP achieved clinical benefits that were not inferior to SP in post-operative management of PD patients with DBS implants; 2. RP reduced the economic burden of patients after surgery, without reducing the number of caregivers required for each program session; 3. Although the RP system was generally reported as satisfactory by the patients, the satisfaction at the domain of interaction and reality is slightly poor. The results of this study provide evidence for the application of remote RP in the field of post-operative management of DBS.\u003c/p\u003e \u003cp\u003eRP was developed to alleviate the burden caused by repeated visits to experienced physicians for maximum treatment effect of DBS; the safety, feasibility, and effectiveness have already been proven [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e, \u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e, \u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e]. No difference was found between the two groups in UPDRS III score or its sub-scores, suggesting this new interface method allows physicians to adjust patients\u0026rsquo; IPG without compromising the effect of DBS on PD patients in the short term.\u003c/p\u003e \u003cp\u003eMost patients gained a significant improvement of quality of life and medication intake. The percent change of the RP vs SP group from baseline to 12 months in PDQ-8 and LEDD were 30% vs 35% and 40% vs 50%, respectively, in line with previous studies [\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e, \u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]. Chen et al. [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e] reported medication adjustments could be more conservative in the RP group. The decrease of LEDD of the RP group was also lower in our study but without statistical difference, perhaps due to treatment variations among physicians.\u003c/p\u003e \u003cp\u003eCompared with SP, RP was considered more flexible in time and space with higher cost-effectiveness. In the current study, the RP group lived significantly farther away from the clinic than the SP group, but the total cost was not significantly higher than that of the SP group, and the average cost of each session was even lower than that of the SP group. In China, the fee of each RP is now set by physicians, which is usually lower than travel cost especially for those outside the area of our center or with mobility issues.\u003c/p\u003e \u003cp\u003eFor caregivers of PD patients with DBS, the advantage of RP is mainly reflected in the time savings benefit from the flexibility, rather than reducing the number of caregivers. The internet-based appointment eliminates geographical limitations, improves the workflow of medical service, and saves waiting time for both physicians and patients. In this study, the mean duration of each RP session was 26.4 min, higher than the average time of outpatient service in China (15.3 min, p\u0026thinsp;=\u0026thinsp;0.016; [\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]); The average age of the patients in this study was 60.5 years old, and some of them are not familiar with smart phones, which makes it necessary for a caregiver to assist during almost each RP programming period. In our center, RP training is provided for both patients and specific caregivers before discharge.\u003c/p\u003e \u003cp\u003eIn addition, the RP of DBS involves many steps (including the connection between the patients\u0026rsquo; controller and the IPG, the connection between the patients\u0026rsquo; controller and internet devices, the connection between physicians\u0026rsquo; computer and the internet, etc.). Smooth network, proficient operation, and the patient\u0026rsquo;s environment could be factors affecting the overall RP experience and treatment effect. In the SP group, the main reason for giving up the RP function on their IPG was the difficulty in mastering the RP system; in the RP group, although the system was generally satisfactory, agreement of the interaction and reality is slightly poor. Perhaps the friendliness of the operation interface and training for patients and their caregivers are key factors in promoting RP in the PD DBS community in the future.\u003c/p\u003e \u003cp\u003eThere was no significant difference in the number of programming sessions between the two groups, but three patients in the RP group had many more RP sessions (21, 16, 42 times; mild outliers) than the average number (median: 5.5 [IQR: 3.5\u0026ndash;18.5]). This may be the result of their subjective perception of poor symptom control, although their U3 improvement was not worse than the average level (31%, 64%, 45%). The convenient access to physicians that RP provided could increase the requests for programming. Zhang et al. [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e] reported an increasing number of programming sessions after the lock-down measures of COVID-19, and 52 out of 909 RP sessions without DBS adjustments were mostly reported to be satisfactory, suggesting the demand for RP would increase as the patients gradually become familiar with RP and the satisfaction was not only associated with DBS itself, but also with their expectations and the psychological support or medical consults during each RP session.\u003c/p\u003e \u003cp\u003eWe compared the stimulation settings between the two groups, and no significance was found in the voltage and frequency, but the pulse width was shorter in the RP group, in accordance with a previous study [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]. A short pulse width below 60 \u0026micro;s could increase the threshold for side effects by avoiding activation of adjacent tissue and widening the therapeutic window [\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e, \u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e], which was used in the titration of voltage/current in the RP programming sessions through fine-tune adjustment. A pulse width of 30 \u0026micro;s was reported to improve gait and speech and to avoid stimulation-induced adverse effects [\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e, \u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e], but these benefits were controversial as they failed to be replicated by randomized, double-blind studies [\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e, \u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eIn the RP group, while most patients finished their initial programming through the traditional in-person method, 4 individuals finished all programming sessions by RP. Initial programming required more detailed parameter titration than reprogramming [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]. No criteria for initial remote programming of DBS in PD has been established yet, and according to our current practice, initial programming by RP may be more suitable for those traveling long distances, with higher levels of caregiver cooperation and cognitive abilities, but the safety and feasibility of RP in initial programming are still to be confirmed by further research.\u003c/p\u003e \u003cp\u003eThis study has several limitations that need to be acknowledged. First, due to the retrospective nature of this study, only associations among variables could be drawn instead of casual relationships; for example, travel cost differed significantly between the two groups, but it is a factor that affects patients\u0026rsquo; attitudes toward the programming method. Second, this is a single-center study; therefore, it remains uncertain whether the results can be generalized to other hospitals. For example, the experience levels of the programming physicians affect the programming frequency and the choice of programming model. Third, we followed up for a relatively short period. In the long term, DBS provides stable improvements of most motor symptoms except for axial symptoms (i.e., gait and balance symptoms, speech, and swallowing difficulty) and cognitive decline [\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e]. For those experiencing troublesome axial symptoms, multiple attempts and observations to obtain optimal stimulation are still recommended [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eIn the future, we intend to conduct prospective studies with larger sample sizes to further validate the effect of RP on more clinical outcomes and explore its benefits for different populations.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eThis 12-month retrospective study demonstrated that compared with standard programming, remote programming conferred non-inferior improvements in motor symptoms for PD patients with subthalamic nucleus (STN) DBS and alleviated the burden of cost for those who live far from specialized centers for short-term follow-ups. The effect of treatment and flexibility in time of RP are the key to achieving personalized post-operative DBS management more easily.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eData Availability\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe datasets used and/or analyzed during the current study available from the corresponding author on reasonable request.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe would like to thank all participants for partaking in the study.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthor Contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eConception and design: D Li. Acquisition of data: C Zhang. Analysis and interpretation of data: X Wan, C Duan. Drafting the article: X Wan, C Duan. Critically revising the article: Z Lin, Z Zeng. Reviewed submitted version of manuscript: all authors. Approved the final version of the manuscript on behalf of all authors: D Li. Administrative/technical/material support: C Zhang.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting Interests statement\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eDianyou Li was funded by the National Natural Science Foundation of China [Grant 81971294 to DL] and the Shanghai Science and Technology Commission International Cooperation Project [Grant 20410712000 to DL]. The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eSchuepbach, W.M., et al., \u003cem\u003eNeurostimulation for Parkinson\u0026apos;s disease with early motor complications.\u003c/em\u003e N Engl J Med, 2013. \u003cstrong\u003e368\u003c/strong\u003e(7): p. 610-22.\u003c/li\u003e\n\u003cli\u003eBronstein, J.M., et al., \u003cem\u003eDeep brain stimulation for Parkinson disease: an expert consensus and review of key issues.\u003c/em\u003e Arch Neurol, 2011. \u003cstrong\u003e68\u003c/strong\u003e(2): p. 165.\u003c/li\u003e\n\u003cli\u003ePicillo, M., et al., \u003cem\u003eProgramming Deep Brain Stimulation for Parkinson\u0026apos;s Disease: The Toronto Western Hospital Algorithms.\u003c/em\u003e Brain Stimul, 2016. \u003cstrong\u003e9\u003c/strong\u003e(3): p. 425-437.\u003c/li\u003e\n\u003cli\u003ePint\u0026eacute;r, D., et al., \u003cem\u003ePotential clinical and economic benefits of remote deep brain stimulation programming.\u003c/em\u003e Sci Rep, 2022. \u003cstrong\u003e12\u003c/strong\u003e(1): p. 17420.\u003c/li\u003e\n\u003cli\u003eChen, Y., et al., \u003cem\u003eThe study on a telemedicine interaction mode for Deep Brain Stimulation postoperative follow-up.\u003c/em\u003e Annu Int Conf IEEE Eng Med Biol Soc, 2015. \u003cstrong\u003e2015\u003c/strong\u003e: p. 186-9.\u003c/li\u003e\n\u003cli\u003eMeng, F., et al., \u003cem\u003eUtilization, surgical populations, centers, coverages, regional balance, and their influential factors of deep brain stimulation for Parkinson\u0026apos;s disease: A large-scale multicenter cross-sectional study from 1997-2021.\u003c/em\u003e Int J Surg, 2023.\u003c/li\u003e\n\u003cli\u003eChen, S., et al., \u003cem\u003eRemote programming for subthalamic deep brain stimulation in Parkinson\u0026apos;s disease.\u003c/em\u003e Frontiers in Neurology, 2022. \u003cstrong\u003e13\u003c/strong\u003e.\u003c/li\u003e\n\u003cli\u003eEsper, C.D., et al., \u003cem\u003eNecessity and feasibility of remote tele-programming of deep brain stimulation systems in Parkinson\u0026apos;s disease.\u003c/em\u003e Parkinsonism Relat Disord, 2022. \u003cstrong\u003e96\u003c/strong\u003e: p. 38-42.\u003c/li\u003e\n\u003cli\u003eNie, P., et al., \u003cem\u003eRemote Programming in Patients With Parkinson\u0026apos;s Disease After Deep Brain Stimulation: Safe, Effective, and Economical.\u003c/em\u003e Frontiers in Neurology, 2022. \u003cstrong\u003e13\u003c/strong\u003e.\u003c/li\u003e\n\u003cli\u003eSaranza, G. and A.E. 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E11.\u003c/li\u003e\n\u003cli\u003eChen, Y., et al., \u003cem\u003eThe study on a real-time remote monitoring system for Parkinson\u0026apos;s disease patients with deep brain stimulators.\u003c/em\u003e Annu Int Conf IEEE Eng Med Biol Soc, 2014. \u003cstrong\u003e2014\u003c/strong\u003e: p. 1358-61.\u003c/li\u003e\n\u003cli\u003eZhang, Y., et al., \u003cem\u003eQuality of Life and Motor Outcomes in Patients With Parkinson\u0026apos;s Disease 12 Months After Deep Brain Stimulation in China.\u003c/em\u003e Neuromodulation, 2023. \u003cstrong\u003e26\u003c/strong\u003e(2): p. 443-450.\u003c/li\u003e\n\u003cli\u003eChen, W., et al., \u003cem\u003eThe efficacy and safety of asleep and awake subthalamic deep brain stimulation for Parkinson\u0026apos;s disease patients: A 1-year follow-up.\u003c/em\u003e Front Aging Neurosci, 2023. \u003cstrong\u003e15\u003c/strong\u003e: p. 1120468.\u003c/li\u003e\n\u003cli\u003eFan, Z., et al., \u003cem\u003eSatisfaction analysis on outpatient experience in 136 tertiary public hospital in China.\u003c/em\u003e Chin J Hosp Admin, 2021. \u003cstrong\u003e37\u003c/strong\u003e(6): p. 460-464.\u003c/li\u003e\n\u003cli\u003eReich, M.M., et al., \u003cem\u003eShort pulse width widens the therapeutic window of subthalamic neurostimulation.\u003c/em\u003e Ann Clin Transl Neurol, 2015. \u003cstrong\u003e2\u003c/strong\u003e(4): p. 427-32.\u003c/li\u003e\n\u003cli\u003eZou, X., et al., \u003cem\u003eEfficacy of short pulse and conventional deep brain stimulation in Parkinson\u0026apos;s disease: a systematic review and meta-analysis.\u003c/em\u003e Neurol Sci, 2023. \u003cstrong\u003e44\u003c/strong\u003e(3): p. 815-825.\u003c/li\u003e\n\u003cli\u003eDayal, V., et al., \u003cem\u003eThe Effect of Short Pulse Width Settings on the Therapeutic Window in Subthalamic Nucleus Deep Brain Stimulation for Parkinson\u0026apos;s disease.\u003c/em\u003e J Parkinsons Dis, 2018. \u003cstrong\u003e8\u003c/strong\u003e(2): p. 273-279.\u003c/li\u003e\n\u003cli\u003eDayal, V., et al., \u003cem\u003eNovel Programming Features Help Alleviate Subthalamic Nucleus Stimulation-Induced Side Effects.\u003c/em\u003e Mov Disord, 2020. \u003cstrong\u003e35\u003c/strong\u003e(12): p. 2261-2269.\u003c/li\u003e\n\u003cli\u003eDayal, V., et al., \u003cem\u003eShort Versus Conventional Pulse-Width Deep Brain Stimulation in Parkinson\u0026apos;s Disease: A Randomized Crossover Comparison.\u003c/em\u003e Mov Disord, 2020. \u003cstrong\u003e35\u003c/strong\u003e(1): p. 101-108.\u003c/li\u003e\n\u003cli\u003ePetry-Schmelzer, J.N., et al., \u003cem\u003eA Randomized, Double-Blinded Crossover Trial of Short Versus Conventional Pulse Width Subthalamic Deep Brain Stimulation in Parkinson\u0026apos;s Disease.\u003c/em\u003e J Parkinsons Dis, 2022. \u003cstrong\u003e12\u003c/strong\u003e(5): p. 1497-1505.\u003c/li\u003e\n\u003cli\u003eLimousin, P. and T. Foltynie, \u003cem\u003eLong-term outcomes of deep brain stimulation in Parkinson disease.\u003c/em\u003e Nat Rev Neurol, 2019. \u003cstrong\u003e15\u003c/strong\u003e(4): p. 234-242.\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"","lastPublishedDoi":"10.21203/rs.3.rs-3383913/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-3383913/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003eFor Parkinson’s disease (PD) patients undergoing deep brain stimulation (DBS), remote programming (RP) was developed to eliminate the burden of repeat office visits for standard programming (SP) sessions to maximize the treatment effect. No studies comparing the treatment effects of RP with SP directly were performed. Thirty-two propensity score matched patients were retrospectively recruited and allocated to the RP or SP group according to their programming methods, and clinical outcomes were compared at ~12-month follow-ups between the two groups. No differences were found in changes of the Unified PD Rating Scale III score, PD Questionnaire-8 score, or levodopa equivalent daily dose between the groups (p\u0026gt;0.05); and the average cost of the RP group decreased compared with their SP sessions (p\u0026lt;0.001), and was less than the average cost of the SP group (p=0.040), even though the patients in the RP group reside further from our center than patients in the SP group (p=0.004). This study demonstrated RP alleviates the cost burden of the short-term follow-ups for PD patients without compromising the DBS treatment effect.\u003c/p\u003e","manuscriptTitle":"The effect of remote programming on deep brain stimulation in Parkinson’s disease: a retrospective study","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2023-10-03 22:40:39","doi":"10.21203/rs.3.rs-3383913/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"7b60dc69-1adb-4e18-b286-8a528a70eba0","owner":[],"postedDate":"October 3rd, 2023","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[{"id":25004469,"name":"Health sciences/Health care/Health services/Rehabilitation"},{"id":25004470,"name":"Health sciences/Neurology/Neurological disorders/Movement disorders/Parkinsons disease"}],"tags":[],"updatedAt":"2023-10-30T07:44:22+00:00","versionOfRecord":[],"versionCreatedAt":"2023-10-03 22:40:39","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-3383913","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-3383913","identity":"rs-3383913","version":["v1"]},"buildId":"WrCJVZZCHTDjtuVLN7oU0","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}