A Sternum-Worn, Non-Invasive Vibrotactile Device to Alleviate Symptoms in Parkinson’s: a Multi-Site Double-Blind Randomised Controlled Trial

A Sternum-Worn, Non-Invasive Vibrotactile Device to Alleviate Symptoms in Parkinson’s: a Multi-Site Double-Blind Randomised Controlled Trial | medRxiv /* */ /* */ <!-- <!-- /*! * yepnope1.5.4 * (c) WTFPL, GPLv2 */ (function(a,b,c){function d(a){return"[object Function]"==o.call(a)}function e(a){return"string"==typeof a}function f(){}function g(a){return!a||"loaded"==a||"complete"==a||"uninitialized"==a}function h(){var a=p.shift();q=1,a?a.t?m(function(){("c"==a.t?B.injectCss:B.injectJs)(a.s,0,a.a,a.x,a.e,1)},0):(a(),h()):q=0}function i(a,c,d,e,f,i,j){function k(b){if(!o&&g(l.readyState)&&(u.r=o=1,!q&&h(),l.onload=l.onreadystatechange=null,b)){"img"!=a&&m(function(){t.removeChild(l)},50);for(var d in y[c])y[c].hasOwnProperty(d)&&y[c][d].onload()}}var j=j||B.errorTimeout,l=b.createElement(a),o=0,r=0,u={t:d,s:c,e:f,a:i,x:j};1===y[c]&&(r=1,y[c]=[]),"object"==a?l.data=c:(l.src=c,l.type=a),l.width=l.height="0",l.onerror=l.onload=l.onreadystatechange=function(){k.call(this,r)},p.splice(e,0,u),"img"!=a&&(r||2===y[c]?(t.insertBefore(l,s?null:n),m(k,j)):y[c].push(l))}function j(a,b,c,d,f){return q=0,b=b||"j",e(a)?i("c"==b?v:u,a,b,this.i++,c,d,f):(p.splice(this.i++,0,a),1==p.length&&h()),this}function k(){var a=B;return a.loader={load:j,i:0},a}var l=b.documentElement,m=a.setTimeout,n=b.getElementsByTagName("script")[0],o={}.toString,p=[],q=0,r="MozAppearance"in l.style,s=r&&!!b.createRange().compareNode,t=s?l:n.parentNode,l=a.opera&&"[object Opera]"==o.call(a.opera),l=!!b.attachEvent&&!l,u=r?"object":l?"script":"img",v=l?"script":u,w=Array.isArray||function(a){return"[object Array]"==o.call(a)},x=[],y={},z={timeout:function(a,b){return b.length&&(a.timeout=b[0]),a}},A,B;B=function(a){function b(a){var a=a.split("!"),b=x.length,c=a.pop(),d=a.length,c={url:c,origUrl:c,prefixes:a},e,f,g;for(f=0;f<d;f++)g=a[f].split("="),(e=z[g.shift()])&&(c=e(c,g));for(f=0;f<b;f++)c=x[f](c);return c}function g(a,e,f,g,h){var i=b(a),j=i.autoCallback;i.url.split(".").pop().split("?").shift(),i.bypass||(e&&(e=d(e)?e:e[a]||e[g]||e[a.split("/").pop().split("?")[0]]),i.instead?i.instead(a,e,f,g,h):(y[i.url]?i.noexec=!0:y[i.url]=1,f.load(i.url,i.forceCSS||!i.forceJS&&"css"==i.url.split(".").pop().split("?").shift()?"c":c,i.noexec,i.attrs,i.timeout),(d(e)||d(j))&&f.load(function(){k(),e&&e(i.origUrl,h,g),j&&j(i.origUrl,h,g),y[i.url]=2})))}function h(a,b){function c(a,c){if(a){if(e(a))c||(j=function(){var a=[].slice.call(arguments);k.apply(this,a),l()}),g(a,j,b,0,h);else if(Object(a)===a)for(n in m=function(){var b=0,c;for(c in a)a.hasOwnProperty(c)&&b++;return b}(),a)a.hasOwnProperty(n)&&(!c&&!--m&&(d(j)?j=function(){var a=[].slice.call(arguments);k.apply(this,a),l()}:j[n]=function(a){return function(){var b=[].slice.call(arguments);a&&a.apply(this,b),l()}}(k[n])),g(a[n],j,b,n,h))}else!c&&l()}var h=!!a.test,i=a.load||a.both,j=a.callback||f,k=j,l=a.complete||f,m,n;c(h?a.yep:a.nope,!!i),i&&c(i)}var i,j,l=this.yepnope.loader;if(e(a))g(a,0,l,0);else if(w(a))for(i=0;i (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];var j=d.createElement(s);var dl=l!='dataLayer'?'&l='+l:'';j.src='//www.googletagmanager.com/gtm.js?id='+i+dl;j.type='text/javascript';j.async=true;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-P4HH5NV'); Skip to main content Home About Submit ALERTS / RSS Search for this keyword Advanced Search A Sternum-Worn, Non-Invasive Vibrotactile Device to Alleviate Symptoms in Parkinson’s: a Multi-Site Double-Blind Randomised Controlled Trial View ORCID Profile Viktoria Azoidou , Essa Bhadra , Ellen Camboe , View ORCID Profile Kamalesh C. Dey , View ORCID Profile Alexandra Zirra , Corrine Quah , Caroline Budu , Thomas Boyle , David Gallagher , Jonathan P. Bestwick , Alastair J Noyce , Cristina Simonet doi: https://doi.org/10.1101/2025.07.19.25331818 Viktoria Azoidou 1 Centre for Preventive Neurology, Wolfson Institute of Population Health, Queen Mary University of London , London, United Kingdom 2 Department of Neurology, Royal London Hospital , Barts Health, London, United Kingdom PhD Find this author on Google Scholar Find this author on PubMed Search for this author on this site ORCID record for Viktoria Azoidou For correspondence: v.azoidou{at}qmul.ac.uk a.noyce{at}qmul.ac.uk c.simonet{at}qmul.ac.uk Essa Bhadra 2 Department of Neurology, Royal London Hospital , Barts Health, London, United Kingdom BSc Find this author on Google Scholar Find this author on PubMed Search for this author on this site Ellen Camboe 1 Centre for Preventive Neurology, Wolfson Institute of Population Health, Queen Mary University of London , London, United Kingdom 2 Department of Neurology, Royal London Hospital , Barts Health, London, United Kingdom MBChB Find this author on Google Scholar Find this author on PubMed Search for this author on this site Kamalesh C. Dey 1 Centre for Preventive Neurology, Wolfson Institute of Population Health, Queen Mary University of London , London, United Kingdom PhD Find this author on Google Scholar Find this author on PubMed Search for this author on this site ORCID record for Kamalesh C. Dey Alexandra Zirra 1 Centre for Preventive Neurology, Wolfson Institute of Population Health, Queen Mary University of London , London, United Kingdom 2 Department of Neurology, Royal London Hospital , Barts Health, London, United Kingdom MBBS Find this author on Google Scholar Find this author on PubMed Search for this author on this site ORCID record for Alexandra Zirra Corrine Quah 3 Neurology Department, Homerton Healthcare NHS Foundation Trust MBBS Find this author on Google Scholar Find this author on PubMed Search for this author on this site Caroline Budu 2 Department of Neurology, Royal London Hospital , Barts Health, London, United Kingdom BN Find this author on Google Scholar Find this author on PubMed Search for this author on this site Thomas Boyle 4 Older Person’s Services & GIM Special Interest in Parkinson’s Disease, Royal London Hospital , United Kingdom MBBS Find this author on Google Scholar Find this author on PubMed Search for this author on this site David Gallagher 2 Department of Neurology, Royal London Hospital , Barts Health, London, United Kingdom PhD Find this author on Google Scholar Find this author on PubMed Search for this author on this site Jonathan P. Bestwick 1 Centre for Preventive Neurology, Wolfson Institute of Population Health, Queen Mary University of London , London, United Kingdom MSc Find this author on Google Scholar Find this author on PubMed Search for this author on this site Alastair J Noyce 1 Centre for Preventive Neurology, Wolfson Institute of Population Health, Queen Mary University of London , London, United Kingdom 2 Department of Neurology, Royal London Hospital , Barts Health, London, United Kingdom PhD Find this author on Google Scholar Find this author on PubMed Search for this author on this site For correspondence: v.azoidou{at}qmul.ac.uk a.noyce{at}qmul.ac.uk c.simonet{at}qmul.ac.uk Cristina Simonet 1 Centre for Preventive Neurology, Wolfson Institute of Population Health, Queen Mary University of London , London, United Kingdom 3 Neurology Department, Homerton Healthcare NHS Foundation Trust PhD Find this author on Google Scholar Find this author on PubMed Search for this author on this site For correspondence: v.azoidou{at}qmul.ac.uk a.noyce{at}qmul.ac.uk c.simonet{at}qmul.ac.uk Abstract Full Text Info/History Metrics Data/Code Preview PDF Abstract Background Effective, measurable, and non-invasive treatments for motor symptoms, gait and balance difficulties, and associated non-motor burden in Parkinson’s disease (PD) remain limited. We aimed to assess the usability, safety/tolerability, and clinical efficacy of CUE1+, a wearable cueing and vibrotactile stimulation non-invasive device, in people with PD. Methods This 12-week, double-blind, randomised controlled trial was conducted at two UK sites in adults with idiopathic PD. Participants were randomly assigned (1:1) to receive either an active CUE1+ device or a sham device, worn on the sternum for 8 hours daily. Participants, investigators, and assessors were blinded to treatment allocation. The primary outcomes were usability and safety/tolerability of CUE1+. Secondary outcomes, including Movement Disorder Society-sponsored revision of the Unified PD Rating Scale (MDS-UPDRS) Part III, were assessed in the ON-medication state at baseline and week 13. Findings Fifty participants were randomised to sham stimulation (Group A; n=25) or active CUE1+ stimulation (Group B; n=25). Median age was 70.0 years (IQR 65.0-75.5) in Group A and 68.0 years (62.0-75.0) in Group B. Group A included 14 (56%) men; Group B, 13 (52%) men. Four participants (8.0%) discontinued: three (6.3%) from Group A, one (2.0%) from Group B. Compliance to allocated intervention was equally excellent in both groups. Mild, transient skin irritation occurred in two participants (4.2%). MDS-UPDRS Part III scores improved by –4.5 points (95%CI: –8.7, –0.4; p=0.043), in Group A and –15.6 points (95%CI: – 20.3, –10.9; p<0.0001) in Group B, with a between-group difference of 11.08 points (95%CI: 4.85-17.31; p=0.002). Interpretation CUE1+ is a safe and well-tolerated non-invasive device that improves motor and non-motor outcomes in PD. These findings suggest a potential therapeutic benefit and support further evaluation in large-scale RCTs and consideration for integration into health care pathways. Funding UKRI Knowledge Transfer Partnership, 2021-2022, round 4 and Charco Neurotech Ltd. Introduction Parkinson’s disease (PD) is a progressive neurodegenerative disorder affecting over 12 million people worldwide 1 . It is characterised by cardinal motor signs including bradykinesia, rigidity, and rest tremor, alongside axial features such as freezing of gait (FOG) and postural instability 2 . Symptomatic management remains the mainstay of treatment, with dopaminergic therapies, particularly levodopa, serving as the gold standard. While pharmacological agents effectively mitigate symptoms at the beginning of the disease course, their long-term use is associated with significant challenges, including motor fluctuations, dyskinesias, and diminished efficacy against axial symptoms 3 , 4 . As the demographic shift towards older populations continues, the prevalence, clinical complexity, and personal and public burden of PD are anticipated to rise steeply 1 , posing urgent challenges for healthcare systems and service planning 5 . One major gap in current treatment lies in managing “OFF” periods, times when medication fails to control motor symptoms adequately 3 , 4 . These fluctuations often become more frequent and unpredictable as the disease progresses, leading to reduced health-related quality of life (QoL) and increased caregiver burden 1 , 5 . Although advanced therapies such as deep brain stimulation (DBS) and continuous infusion therapies are available in many countries, they are invasive, expensive, and not suitable for all patients 6 , 7 . Additionally, a wide array of prodromal, non-motor symptoms including hyposmia, depression, anxiety, cognitive dysfunction, REM sleep behaviour disorder, and autonomic dysfunction that may precede and progress alongside motor signs 2 , 8 . These non-motor features, are frequently under-recognised, often inadequately addressed by pharmacotherapy, substantially diminish QoL, and drive caregiver burden and healthcare demand 7 . These challenges have led to growing interest in non-pharmacological strategies that target motor control and functional mobility without introducing additional systemic side effects. Among these, neuromodulatory wearables represent a promising frontier. The CUE1+ device, a non-invasive vibrotactile stimulator designed to be worn externally, aims to provide real-time sensory cueing with vibrotactile stimulation to improve motor function in people with PD 9 , 10 . Based on the principles of sensory-motor integration and cueing theory, such devices may help mitigate FOG, bradykinesia, and akinesia through peripheral stimulation and entrainment 9 , 11 , 12 , 13 – 15 . Rhythmic sensory cues whether auditory, visual, or tactile may activate alternative neural pathways, compensating for dysfunctional basal ganglia circuits in PD 12 , 16 . By introducing external sensory input, vibrotactile cueing devices like CUE1+ may offer a safe, accessible, and user-controlled method to support mobility and independence in everyday settings 9 . High-quality evidence for wearable vibrotactile cueing devices remains limited 11 , 12 , highlighting the need for blinded randomised controlled trials (RCTs) to confirm their benefits and assess long-term use. This double-blind RCT aimed to evaluate the usability, and safety/tolerability of CUE1+. Secondary exploratory outcomes included motor function improvement compared to sham device intervention, as well as gait, balance, falls, non-motor symptoms, and QoL. The trial also aimed to inform future RCT design and align with NICE and NHS England guidance 17 , 18 , which emphasise real-world, patient-centred studies. Interest in discreet wearable technologies is high among patients 19 . Based on prior findings 9 , we hypothesised successful recruitment, high adherence, minimal adverse events, and greater improvements in the active CUE1+ group. Methods Study design This was a 12-week, multi-centre, double-blind, pilot RCT conducted at the Centre for Preventive Neurology, Queen Mary University of London (QMUL), in collaboration with Barts Health NHS Trust and Homerton Healthcare NHS Foundation Trust. The trial was approved by the London-Dulwich Research Ethics Committee (reference: 23/PR/1526), was registered prospectively with ClinicalTrials.gov ( NCT06174948 ), and adhered to the principles outlined in the Declaration of Helsinki. An independent Patient and Public Involvement and Engagement advisory group contributed to the review of all study documentation and monitored trial progress. The protocol and statistical analysis plan were approved before the first participant was enrolled. The study protocol is available in the public domain 10 . Participants Participants were identified from the Neurology Department at Barts Health NHS Trust and the Department of Care of the Elderly at Homerton Healthcare NHS Foundation Trust. All study assessments were conducted at the Centre for Preventive Neurology, QMUL. Written informed consent was obtained from all participants before any study-related procedures were undertaken. Eligible participants met the following inclusion criteria: a clinical diagnosis of PD according to the Movement Disorder Society criteria 20 , age≥18 years, capacity and willingness to participate, and provision of written informed consent following review of the participant information sheet. Exclusion criteria included the presence of any medical or neurological conditions other than PD that could interfere with movement, balance, or independent participation in the trial. These included atypical parkinsonian syndromes, osteoarticular disorders, significant visual problems, audio-vestibular impairments, and a clinical diagnosis of dementia or Alzheimer’s disease. Participants were also excluded if they were receiving any non-standard therapeutic, cueing, or vibrotactile stimulation interventions, or if their Parkinson’s medication had not been stable for at least 3 months prior to enrolment. Additional exclusion criteria comprised the presence of a) implanted metallic or electronic devices such for DBS; b) known hypersensitivity to vibrotactile stimulation; and/or c) dermatological conditions or open wounds at or near the intended site of device application (i.e., the sternum). Demographic and clinical data were collected at baseline, including age, sex, ethnicity, disease duration, disease severity (Hoehn and Yahr staging) 21 , and cognitive status as measured by the Montreal Cognitive Assessment (MoCA) 22 . A MoCA score ≥26/30 was interpreted as consistent with normal cognition. Sex and ethnicity were self-reported according to categories based on the UK Office for National Statistics 23 classification. Participants could choose not to disclose this information. Ethnicity data were collected solely for descriptive statistics. Randomisation and masking At the time of protocol publication 10 , treatment allocation was masked. After trial completion, Group A was unmasked as the sham intervention and Group B as the active non-invasive vibrotactile device. Masking of participants, investigators and assessor was maintained throughout the study until completion of data collection and analysis. Randomisation was done centrally using a secure, web-based system ( www.sealedenvelope.com ), employing permuted blocks of varying sizes (2, 4, 6) to ensure allocation concealment and minimise predictability (Appendix 1). Multiple pre-labelled randomisation sequences (1-4) and block identifiers (1-14) were used to track allocation without compromising blinding. One researcher (CS), not involved in assessments or analysis, managed the randomisation process and held exclusive access to allocation codes. These codes were securely stored and inaccessible to other team members. Outcome assessments were done by VA, and data were analysed by VA and JPB, both masked to group allocation throughout. No emergency unblinding occurred or was anticipated, owing to the non-invasive nature of the intervention and the absence of adverse events in the feasibility study 9 . Procedures Participants assigned to the experimental group (Group B) used the CUE1+ device for 12 weeks (intervention weeks 1-12). CUE1+ is a non-invasive, MHRA-registered medical device developed by Charco Neurotech Ltd (Appendix 2). It delivers combined tactile cueing and vibrotactile stimulation and is worn on the sternum using a dermatologically approved adhesive patch. Participants were instructed to wear the device daily for 8 hours, starting each day from the morning, beginning one hour after taking their routine dopaminergic medication. Stimulation was delivered at 80% of the device’s maximum vibration strength, with pulse and rest intervals of 800 ms each, based on effective parameters reported in previous work 9 , 10 . Participants in the control group (Group A) received an identical sham device, visually and functionally indistinguishable from the active version but with vibrotactile output disabled (0% vibration strength; 0 ms pulse and rest duration). To maintain blinding, participants were informed that stimulation might be subtle or imperceptible. The usage protocol was identical that of Group B. Both groups received training and written instructions, including a support booklet detailing device operation, patch application, and charging. Additional support was provided as needed during the trial. Supplementary instructions were made available and are accessible with the published protocol 10 . Participants continued their usual antiparkinsonian medications throughout the trial. Any necessary medication changes led to participant withdrawal, at which point data collection ceased. Consent was obtained to retain data collected up to withdrawal. Participants could also withdraw at any time, with previously collected data retained if they agreed. All protocol deviations and violations were reported to the study sponsor. Following unblinding, Group A participants were informed of their allocation, asked to return the sham device, and offered an active CUE1+ for use outside the trial. All participants were offered the CUE1+ upon trial completion, irrespective of group Outcomes The primary outcome was CUE1+ usability at home over 12 weeks, including recruitment rate, compliance with intervention, dropout rates, and safety/tolerability. Site-level usability included engagement and recruitment performance. Protocol compliance was monitored through adherence to core study procedures, including timely delivery of interventions, consistency in outcome assessments, and data collection completeness. Investigators also recorded the proportion of people screened who met inclusion criteria, were approached for participation, consented, and were ultimately randomised. Participant-level usability included compliance to the allocated intervention, retention through the 12-week follow-up, and completeness of baseline and outcome data. Compliance with the assigned intervention across the 12-week period was assessed using two self-report measures. Participants were first asked to indicate their usage frequency of the CUE1+ device on a 5-point Likert scale ranging from 0 (did not use it at all) to 4 (used it daily as advised, i.e., 8+ hours/day). Additionally, they were asked to provide a subjective rating of their overall compliance on a continuous scale from 0 (not compliant at all) to 10 (completely compliant). Safety and tolerability were monitored throughout, including any clinical events and adverse events. Device malfunctions in both active and sham groups were logged. In the end of the study, all participants completed a satisfaction questionnaire on their experience with CUE1+, as published with the trial protocol 10 . The questionnaire utilised a 5-point Likert scale, ranging from 0 (not at all) to 4 (extremely), to assess various aspects of participant satisfaction. Scores for all endpoints were subsequently compared between groups. Clinical visits were conducted at baseline (week 0) and follow-up (week 13), each lasting approximately half a day. These visits included motor assessment and completion of self-reported outcome questionnaires. To mitigate fatigue-related bias, the order of assessments was randomised, and rest breaks were offered. The full assessment schedule is available in the published protocol 10 . Secondary exploratory outcomes included clinical efficacy measures. Details on all clinical efficacy measures, scoring procedures, minimal clinically important differences (MCIDs) and additional reference list are provided (Appendix 3). These outcomes were evaluated to inform the design of a future definitive RCT. Motor assessments included the Movement Disorder Society-sponsored revision of the Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part III 24 , Functional Gait Assessment 25 , Timed Up and Go (TUG) 26 , TUG with dual-task using serial sevens, and the two keyboard-based tapping tests to measure hand dexterity and movement (e.g., kinesia), Bradykinesia Akinesia INcoordination (BRAIN-Kinesia Score; KS) 27 and Digital Finger Tapping (DFT-KS) 28 tests for the most affected side. Optional video recordings of the MDS-UPRDS Part III assessments were retained for educational purposes to QMUL, with participant consent. All motor testing was performed in the ON-medication state (45-60 minutes after dopaminergic therapy). Participants stopped wearing the device just before attending the follow-up assessment to maintain blinding of the assessor. Another secondary exploratory measure was the Parkinson’s KinetiGraph (PKG) 29 wristwatch (Appendix 3). Participants wore the PKG wristwatch continuously on their most affected side for 13 weeks, beginning on the day of the baseline assessment (week 0) and concluding after the week 13 follow-up. They only removed the PKG when this needed to be charged for approximately two hours every 6-7days. The main data points collected from the PKG system are also included in the published protocol 10 . Patient-reported outcomes covered both motor and non-motor domains and included the MDS-UPDRS Parts I, II, and IV 24 , Activities-specific Balance Confidence Scale (ABC) 30 , Pittsburgh Sleep Quality Index (PSQI) 31 , Parkinson’s Disease Questionnaire–39 (PDQ-39) 32 , Hospital Anxiety and Depression Scale (HADS) 33 , Fatigue Severity Scale (FSS) 34 , and Patient Global Impression of Change 35 . Statistical analysis Statistical analyses were conducted using IBM SPSS Statistics (version 29; IBM Corp., Armonk, NY, USA). Descriptive statistics were used to summarise baseline characteristics and outcome data. For continuous variables, normally distributed data are presented as mean (standard deviation; SD), and non-normally distributed data as median (interquartile range; IQR). Categorical variables are shown as absolute (number; n) and relative (percentage; %) values. Normality of distributions was assessed using the Shapiro-Wilk test, supported by histogram and Q–Q plot inspection. Ninety-five per cent confidence interval (95% CI) are reported where appropriate to indicate precision. Between-group comparisons at baseline and follow-up were conducted using independent samples t tests for normally distributed variables, and Mann-Whitney U tests for non-normally distributed variables. Within-group comparisons were assessed using paired t-tests (normal distribution) or Wilcoxon signed-rank tests (non-normal distribution). When one timepoint was normally distributed and the other was not, non-parametric methods were used to preserve validity. An intention-to-treat (ITT) approach was used for all clinical efficacy outcomes. Data from participants who discontinued the intervention or deviated from the protocol were retained in the analysis unless consent was withdrawn. To enhance clinical interpretability, results were also assessed using established MCIDs for outcomes related to PD, where available. MCIDs provide a more patient-centred benchmark than purely statistical metrics such as minimal detectable change (MDC) 36 . Bonferroni correction was considered for multiple comparisons of secondary effectiveness outcomes (e.g., p<0.004 for 14 outcomes). As a pilot RCT, no priori power calculation was performed. The sample size was guided by Sim and Julius 37 , who recommend 20-75 participants per arm to detect moderate to large effects. Drawing from feasibility data, including a previous single-arm study 9 involving ten participants, the target sample was initially set at 20 per group. To account for an anticipated dropout rate of up to 25% given the use of a sham comparator, the final recruitment goal was increased to 25 participants per group. Post hoc sample size and power calculations for a future definitive RCT were conducted. Parametric or non-parametric methods were used depending on data distribution, accounting for dropout, and targeting 80% power at alpha (a) equal 0.05. Role of the funding source The funder of the study (UKRI Knowledge Transfer Partnership and Charco Neurotech Ltd) had no role in the study design, data collection, data analysis, data interpretation, or writing of the report. The corresponding authors had full access to all the data in the study and had final responsibility for the decision to submit for publication. Results The trial was completed as planned, without delays or protocol amendments. As outlined in the protocol 10 , several exploratory secondary outcomes were pre-specified, though PKG data were not included. During data analysis, PKG monitors showed substantial variability in data completeness and standardisation. To maintain scientific validity follow-up PKG data (weeks 1-13) were excluded. Baseline PKG data (week 0), recorded before intervention, are included for between-group comparison of real-world activity. This approach aligns with best practice guidelines for reporting and data integrity 38 . Between September 1, 2024, and February 28, 2025, a total of 58 individuals were screened for eligibility: 13 (22.4%) at Homerton University Hospital and 45 (77.6%) at Barts Health NHS Trust. Of those screened, 5 (8.6%) did not meet inclusion criteria, and 3 (5.2%) declined participation due to personal reasons ( Figure 1 ). The remaining 50 were randomly assigned to the control group (Group A) or the intervention group (Group B). Of those randomised, 7 (14.0%) were recruited from Homerton University Hospital and 43 (86.0%) from Barts Health NHS Trust. Baseline characteristics of all participants are shown in Table 1 . Seven (30%) of participants in Group A and 11 (44%) in Group B were from non-white ethnic origin. Download figure Open in new tab Figure 1: Trial profile. Group A involved participants who received sham device intervention while Group B involved participants who received active device intervention. View this table: View inline View popup Download powerpoint Table 1: Baseline characteristics of the intention-to-treat population. Recruitment rate was considered high (86%) consistent with our previous clinical study 9 , which likely reflects the non-invasive nature of the intervention and strong site engagement. Four participants (8.0%) discontinued the trial, 3 (6.3%) from Group A and 1 (2.0%) from Group B. The overall dropout rate was low and within the expected range for a study of this design and duration. The intervention was well tolerated across both groups, with minimal adverse events. Mild, transient skin irritation at the adhesive patch site occurred in two participants (4.2%), one in each group, and resolved without treatment. One Group B participant (2.1%) reported dizziness during use at the pre-set vibration intensity; however, this coincided with generalised dizziness unrelated to the device, and the participant withdrew due to an intercurrent illness. After the trial, they resumed use of the CUE1+ independently and increased vibration intensity from 50% to 70% via the CUE App (not used during the trial), without recurrence of dizziness. No participants reported difficulty with patch application or removal. A single technical malfunction occurred in Group B and was promptly resolved by an unblinded researcher (CS) in coordination with Charco Neurotech Ltd. A replacement device was delivered within days, and no further technical issues were reported. Overall, the intervention demonstrated a favourable safety and usability profile. Participant-level usability and compliance were excellent with no notable between-group difference ( Table 2 ). Participants in Group B found the CUE1+ more helpful in managing their symptoms compared with those in Group A [-1.1 (−1.7, –0.5), p=0.001] ( Table 3 ). Group B expressed a higher likelihood of continuing device use beyond the trial period [1.0 (0.5, 1.0), p=0.004]. However, there was no difference in whether participants in groups A and B would recommend the intervention to others with PD [0.0 (0.0, 1.0), p=0.336]. View this table: View inline View popup Table 2 Participant-level usability and compliance to intervention. View this table: View inline View popup Table 3 Participants’ perspective on receiving CUE1+ intervention. At baseline, there were not significant between-group differences for secondary effectiveness outcomes (Appendices 4 and 5). At follow-up, significant between-group improvements were noted on MDS-UPDRS Part III [11.1 (4.9, 17.3; p=0.002] ( Figure 2 ) and PDQ-39 [Summary Index; SI: –7.6 (−12.3, –3.0), p=0.003] in favour of Group B (Appendix 6). The median PGIC “change since care” score at follow-up was 2.0 in Group A (1.0, 3.5) and 4.0 in Group B (2.0, 5.0), with a trend toward better ratings in Group B (p=0.051). The PGIC “degree of change” score was 5.0 in Group A (4.0, 5.0) and 3.0 in Group B (3.0, 4.0), showing a more notable between-group difference in favour of Group B [-2.0 (−2.0, –0.5), p=0.012]. Download figure Open in new tab Figure 2: Box plot (median, confidence interval, 1st and 3rd quartiles, maximum and minimum) showing the results of MDS-UPDRS Part III scores at baseline and week 13 for sham and active device group. The sham device group showed a mean change of –4.5 points (95% CI: –8.7, –0.4; p = 0.043), while the active device group had a mean change of –15.6 points (95% CI: –20.3, –10.9; p < 0.0001). The between-group difference in change was 11.1 points (95% CI: 4.9, 17.3; p = 0.002). After applying the Bonferroni correction, the threshold for statistical significance was adjusted from p < 0.05 to p < 0.004. **p<0.01, ***p<0.001. Sham device group is referred as Group A in the main manuscript while active device group as Group B. Participants wearing the active device (Group B) showed a notably greater within-group improvement on objective motor outcomes compared to those who received the sham device (Group A). This included significantly greater improvements on the MDS-UPDRS Part III [Group B: –15.6 (−20.3, –10.9), p<0.0001; Group A: –4.5 (−8.7, –0.4), p=0.043] ( Figure 2 ), and on the BRAIN KS test [Group B: 3.0 (0.0, 12.0), p=0.007; Group A: 3.0 (0.0, 7.0), p=0.056], although the within-group changes in the latter were not statistically significant. Group B also showed more notable improvements on the FGA [Group B: 3.0 (2.0, 4.0), p<0.0001; Group A: 1.2 (0.0, 2.5), p=0.053] (Appendix 7). These motor improvements were further supported by participant self-reported outcomes on motor symptoms, specifically MDS-UPDRS Part II [Group B: –4.0 (−7.0, –1.0), p<0.0001; Group A: 0.0 (3.0, 0.0), p=0.980], as well as Part I [Group B: –4.0 (7.0, 2.0), p<0.0001; Group A: 0.0 (3.0, 0.0), p=0.410] and Part IV [Group B: –4.0 (5.0, –3.0), p<0.0001; Group A: 0.0 (0.0, 1.0), p=0.850]. In addition, improvements were observed in self-reported outcomes on non-motor symptoms, including the PSQI [Group B: –2.0 (−3.0, –1.0), p<0.0001; Group A: –0.7 (−2.2, 0.9), p=0.401], PDQ-39 Summary Index [Group B: –7.5 (−11.5, –3.4), p<0.0001; Group A: 0.1 (−2.9, 3.1), p=0.925], and the PDQ-39 Activities of Daily Living component [Group B: –12.5 (−12.5, – 4.2), p<0.0001; Group A: –4.2 (−8.3, 0.0), p=0.073]. A post hoc power analysis was conducted based on changes in MDS-UPDRS Part III, the gold standard for motor assessment in PD 24 . Participants in Group B demonstrated a mean improvement of 15.6 points (SD=13.3), compared to a 4.5-point improvement (SD=13.2) in Group A, yielding a mean between-group difference of 11.1 points and a standardised effect size (Cohen’s d) of 0.88. Based on this effect size, a future two-arm, fully powered RCT would require 33 participants per group to achieve 80% power and 52 participants per group to achieve 95% power, assuming a two-tailed alpha of 0.05. Accounting for the observed dropout rate of 8%, the adjusted sample size estimates increase to 36 and 57 participants per group for 80% and 95% power, respectively. However, accounting for a projected dropout rate of 25% due to a sham intervention involvement, the adjusted sample size estimates would increase to 44 and 70 participants per group for 80% and 95% power, respectively. These findings suggest that a fully powered RCT is feasible and could be conducted with a relatively modest sample size. Discussion This double-blind, multicentre double-blind RCT provides robust preliminary evidence supporting real-world usability, safety/tolerability and clinical efficacy of the CUE1+ device in management of PD. Compared with the sham control, participants who received the active device experienced greater clinically meaningful improvements across multiple domains. These included motor severity and complications of treatment, functional gait, falls risk, non-motor symptoms such as sleep quality, self-reported impression of change, and overall QoL over 12 weeks. These benefits were achieved with high recruitment rate and compliance to intervention, minimal adverse effects, and positive participant experience, factors which are important when considering integration into routine care. Although 43.5% of participants using the sham device met the MCID threshold on the MDS-UPDRS Part III, consistent with known placebo responses in PD when exposed to interventions 14 , the significantly greater proportion achieving this in the active device group (84%) supports a genuine therapeutic effect. In our study, we used –3.25 points as the MCID cutoff, based on Horváth et al. 39 who employed robust anchor-based methods in a large longitudinal cohort. In contrast, Sánchez-Ferro et al. 40 proposed a more conservative ±5-point threshold using the original UPDRS-III in a pragmatic setting. The discrepancy likely reflects differences in methodology, population characteristics, and particularly, the use of the revised MDS-UPDRS versus the original UPDRS. Notably, the threshold in the study by Sánchez-Ferro et al. 40 applies to UPDRS-III, while the estimate in study conducted by Horváth et al. 39 concerns MDS-UPDRS Part III, which may be more sensitive to change as this was assessed by anchor_based methods 39 . Standardising MCID definitions across UPDRS versions remains critical for consistent interpretation and comparison. Falls remain a major issue in PD, with 45% to 60% falling each year and two-thirds experiencing recurrent falls 41 . While this study indicated reduced fall risk (e.g., FGA) following the CUE1+ intervention, the MCID 25 was achieved only by 20% of participants. Longer duration follow-up might be required to observe meaningful changes in more patients and to confirm sustained benefit. Future research should also examine how vibrotactile stimulation affects medication use in PD, particularly given observed improvements in motor complications assessed on MDS-UPDRS Part IV. An observational study showed levodopa doses remained stable in patients using vibrotactile devices, while increasing in others, suggesting better symptom control 15 , potentially also reducing falls risk. Sleep disturbances are prevalent in PwP 42 and were evident in this study, with participants exhibiting abnormal PSQI scores. Although scores improved following the intervention, they remained clinically abnormal, highlighting the potential need for longer or sleep-targeted adjunctive therapies. Given the bidirectional relationship between motor severity and sleep symptoms, addressing one may improve the other 42 , 43 . Future research should employ more sensitive sleep assessments and explore combined approaches, such as vibrotactile cueing with sleep interventions. Improvements in sleep and balance confidence may reflect not only motor gains but also vagally mediated effects on arousal, anxiety, and overall QoL 4 . The later might be improving also due to improvements in motor symptoms. The findings from this study emerge at a critical time in UK policy, as NHS England and NICE seek to integrate evidence-based, patient-led digital health solutions into care pathways 17 , 18 . NICE 2023 request for evidence generation positions remote monitoring, wearable devices, and non-pharmacological strategies as key priorities for service innovation. The CUE1+ aligns directly with these aims. It has demonstrated applicability across motor and non-motor domains with no serious adverse events, making it a suitable candidate for broader implementation and NICE Medical Technologies Evaluation Programme (MTEP) review 44 . MTEP is recommended to support system-wide adoption, integration with NHS Digital frameworks. A targeted evaluation of cost per quality-adjusted life year (QALY) gained, drawing on improvements in motor function, falls prevention, and sleep, could justify scale-up. The pragmatic, home-based design and positive real-world usability profile of CUE1+ position it as a strong candidate for future commissioning decisions. According to current treatment frameworks outlined in the updated NICE pathways for managing PD 45 , there may be a need for modalities and treatment options to be explored to support and enhance physiotherapy, occupational therapy, and speech and swallowing interventions, areas often limited by barriers such as cost, travel demands, and reduced patient motivation 43 . Future research should explore the implementation of vibrotactile devices designed for home use including CUE1+ across multiple care pathways. Furthermore, as CUE1+ shows potential in addressing postural instability, falls, and motor complications, this may position the device as a valuable adjunct in the management of complex, late-stage PD. Its use and contribution to reduce hospitalisation rates and caregiver burden, should be investigated in advanced care settings. This RCT provides a foundation for a larger, multisite fully powered trial with a sample size estimation, and long-term follow-up to confirm efficacy and examine diversity in subgroup responses based on factors such as disease duration and severity, fall history, and cognitive status. Although not powered for economic evaluation, the large effect size (Cohen’s d=0.88) supports the need for future cost-utility analyses comparing CUE1+ with standard care, incorporating QALYs and NHS resource use to inform potential NICE Medical Technologies Guidance 44 . Future studies should also include head-to-head comparisons with other non-invasive neuromodulation devices (e.g., vibrotactile insoles, gloves, acoustic metronomes) to refine indications and positioning. Neuroimaging and electrophysiology could clarify the neural basis of clinical improvements, particularly in motor network reorganisation and sensorimotor integration 12 . Concurrently, wearable sensors such as accelerometers and fall detectors should continue to be used to collect real-world data which may help generate objective gait and posture data, enabling digital biomarker development. Real-world implementation will require research into clinician and patient uptake, digital inclusion, training needs, and equitable access. Co-design with people living with PD, caregivers, and healthcare professionals will be critical to ensure the device is acceptable, accessible, and seamlessly integrated into routine care. This study has several limitations. The sample size, while sufficient for preliminary assessment, limits generalisability and prevents detailed subgroup analyses. Key questions remain about whether vibrotactile stimulation improves symptoms less responsive to medication, such as tremor and FOG, and whether benefits extend across diverse populations. The study was also not powered to assess economic outcomes or specific effects in underrepresented groups, including those with advanced PD, cognitive impairment, or non-English-speaking backgrounds. The 12-week follow-up period restricts conclusions about long-term efficacy and sustainability of benefits especially around falls and QoL. Fixed stimulation parameters were used throughout, meaning the potential advantages of personalised dosing were not assessed. Compliance and some outcomes were self-reported, introducing the possibility of bias despite supporting in-person assessments. To conclude, the CUE1+ device appears to be a promising, non-invasive adjunct for managing motor and non-motor symptoms in PD, offering meaningful improvements across multiple domains of function and QoL. Its real-world usability, safety and tolerability suggests strong potential for integration into NHS care pathways. These findings support further assessment in a definitive RCT. Contributors VA, AJN, and CS (along with Patient and Public Involvement and Engagement members) were involved in the conception, design and writing and editing of the study protocol. VA, CS and AJN were involved in the conception and editing of the protocol. VA, EB, EC, KCD, AZ, CQ, CB, TB, DG, AJN, and CS were involved in participants’ identification. JPB carried out the statistical analysis and reviewed the methodology and results sections of the manuscript. VA was involved in participants’ recruitment and assessments. CS was responsible for randomisation and blinding procedures. All authors reviewed and approved the final version of the manuscript prior submission. AJN and CS contributed equally to this manuscript as senior authors. Declaration of interests We declare no competing interests. Data sharing Access to the dataset can be granted by contacting the corresponding author. Authors are committed to making the research data that supports this article available, wherever legally and ethically feasible. Therefore, data collected for the study, including deidentified individual participant data and a data dictionary defining each field in the set, will be made available to others. Additional, related documents can be also available upon request (e.g., study protocol, statistical analysis plan, informed consent form). This data sharing plan is in line with International Committee of Medical Journal Editors guidelines. The authors have updated the clinical trial registry to ensure compliance with the scientific peer-preview journals data sharing policy. Data Availability Access to the dataset can be granted by contacting the corresponding author. Authors are committed to making the research data that supports this article available, wherever legally and ethically feasible. Therefore, data collected for the study, including deidentified individual participant data and a data dictionary defining each field in the set, will be made available to others. Additional, related documents can be also available upon request (e.g., study protocol, statistical analysis plan, informed consent form). This data sharing plan is in line with International Committee of Medical Journal Editors guidelines. The authors have updated the clinical trial registry to ensure compliance with the scientific peer-preview journals data sharing policy. https://clinicaltrials.gov/study/NCT06174948 Acknowledgments We would like to thank all participants for taking part in this study. We appreciate the efforts of all the authors for this article. This study is part of the project funded by Knowledge Transfer Partnership (KTP) United Kingdom 2021 to 2022, round 4, UKRI KTP (Innovate UK) and we would like to thank the organisation for the funding. We would like to thank Charco Neurotech Ltd for providing the CUE1+ devices and adhesives for the duration of the study, and for generously gifting CUE1+ devices along with a three-month supply of adhesives to all participants who wished to continue using the device post-study. We also gratefully acknowledge Charco Neurotech Ltd for covering the costs associated with the PKG wristwatches used in the study. Finally, we are grateful to the support that Ms Kira Rowsell has offered with communicating CUE1+ information at Homerton University Hospital. Appendices Appendix 1: Randomisation list View this table: View inline View popup Download powerpoint Appendix 2: The CUE1+ device Download figure Open in new tab The CUE1+ is a non-invasive medical device designed to support the management of both motor and non-motor symptoms in people living with Parkinson’s. The device is compact and discreet (dimensions: 40 mm in diameter, 11 mm in height; weight: 17 g) and is affixed to the sternum using dermatologically tested adhesive patches. While it is water-resistant, it is not waterproof and should be removed prior to showering. When activated, the device delivers targeted vibrotactile stimulation via a silent motor, employing a proprietary waveform informed by extensive user feedback and clinical research. It integrates low-frequency auditory cueing with high-frequency vibrotactile stimulation, delivered in a structured pattern intended to optimise therapeutic benefit. A sham version of the CUE1+ is used as a control within the trial. It is externally identical to the active device, but its therapeutic functions have been fully disabled. Appendix 3: Description of motor and non-motor outcomes View this table: View inline View popup Reference list 1. 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