Home Use Study of Targeted Mechanical Stimulation for Tremor Relief (NCT07078422)
🩺 Plain-English Summary (8th-Grade Level)
Subjects will receive prototype devices to be used for participation. The study comprises three phases: 1. Alpha phase: Two remote study visits and an in-home period to gather device usability data on the alpha system. The at home period for this phase will be 2 weeks. This phase will be used to confirm that the device and labeling are suitable for in-home use. 2. Beta Phase B1: Beta Phase B1 will be conducted using the beta devices for two in-person or remote, 60 to 90-minute, visits. This phase will be used to assess design changes between alpha and beta versions. 3. Beta Phase B2: Seven remote visits and in-home usage to gather usability and efficacy data on the beta system in-home. Beta Phase B2 will be conducted using the beta devices for 12 weeks. This phase will be used to assess design changes between alpha and beta versions.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (22 items).
Location: Encora Therapeutics — Cambridge, Massachusetts
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria - Alpha and Beta Phase B1
- Pregnant women
- Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions of skin at stimulation site
- History of psoriasis, eczema or atopic dermatitis at the stimulation site
- History of peripheral neuropathy in the upper limbs, including carpal tunnel syndrome and diabetic neuropathy
- Participant unable to communicate with sponsor/investigator and staff
- Any other medical conditions or physical or mental impairments that in the sponsor/investigator's opinion would render the subject unsuitable as a candidate for the study. Inclusion Criteria - Beta Phase B2
- Age 18 years or older, able to comply with all study procedures and capable of providing informed consent
- Mentally competent to understand and able to perform written, informed consent to participate in the study
- For ET subjects, a diagnosis of essential tremor defined as definite or probable ET based on TRIG criteria
- For PD subjects, a diagnosis of Parkinson's disease by a Movement Disorder Specialist
- For ET subjects, at least one hand exhibiting tremor \> 2 as assessed by the Essential Tremor Rating Assessment Scale (TETRAS) finger to nose task, duck wing task, OR Archimedes Spiral completed during the Screening visit
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Encora Therapeutics — Cambridge, Massachusetts
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.