CREST: Samphire Guided Care Program on Wellbeing, Work Productivity, and Quality of Life
- Enrollment
- 50
- Start
- 2026-06-01
- Completion
- 2027-03-01
- Last updated
- 2026-07-01
- Has results
- False
- Countries
- United States
Conditions
Tagged with
Interventions
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Lutea Transcranial Direct Current Stimulation (tDCS) Device
DEVICE
The Lutea device (Samphire Group, Inc.) is an FCC-registered consumer wellness wearable that delivers low-intensity transcranial direct current stimulation (tDCS) targeting the primary motor cortex (M1) and dorsolateral prefrontal cortex (DLPFC). Sessions are 20 minutes in duration at a recommended frequency of multiple sessions per week, self- administered at home. The device does not meet the FDA's statutory definition of a medical device; it is intended for general wellness purposes and is not cleared or approved for the diagnosis, cure, mitigation, treatment, or prevention of any disease.
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Samphire Guided Care Program
BEHAVIORAL
A 12-week structured digital health program comprising: clinician-led neuromodulation eligibility assessment and care pathway assignment at onboarding; ongoing neuromodulation coach support; and app-based daily symptom tracking via the Alethios digital research platform. All participants in both groups receive this program component.
Eligibility criteria
Courtesy of ClinicalTrials.gov / U.S. National Library of Medicine