Targeted mechanical stimulation used at home to relieve tremors
Official title: Home Use Study of Targeted Mechanical Stimulation for Tremor Relief
Run by Encora, Inc. · NCT07078422 · Data updated 2026-11-12
This project will try a wearable device that delivers targeted mechanical stimulation at home to reduce moderate-to-severe upper limb tremors in adults with essential tremor or Parkinson's disease.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Encora, Inc. Industry-sponsored |
| Locations | 1 site (Cambridge, Massachusetts) |
| Status | Recruiting |
| Started | January 1, 2025 |
| Main results expected | December 2025 |
| Study ends | June 2026 |
| Registry record updated | November 24, 2025 |
| Trial ID | NCT07078422 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older with a clinical diagnosis of essential tremor or Parkinson's disease, moderate-to-severe upper limb tremor, the ability to consent and comply with procedures, and no excluded skin or neuropathic conditions are ideal candidates.
✕Probably not a fit
People who are pregnant, have skin disease or open wounds at the stimulation site, have upper-limb peripheral neuropathy, or have other medical or communication limitations may not receive benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with essential tremor or Parkinson's disease and moderate-to-severe upper-limb tremor will receive prototype Encora Pulse devices to use at home. The work is done in three phases: an alpha phase with two remote visits and a two-week home use period to check basic usability and labeling, a Beta B1 phase with two 60–90 minute in-person or remote visits to review design changes, and a Beta B2 phase with seven remote visits and 12 weeks of in-home use to collect usability and preliminary efficacy data. The protocol combines remote monitoring, participant-reported use, and periodic visits to gather feedback and tremor-related outcomes. Data will be used to refine the device for safe and practical at-home use.
Why it matters
Potential benefit: If successful, the device could provide non-drug, at-home reduction of upper-limb tremor and improve everyday function.
How similar studies have gone: Some small prior studies of peripheral mechanical or sensory stimulation have shown promising tremor reductions, but the evidence is limited and this specific device approach remains relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria - Alpha and Beta Phase B1 * 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 * A diagnosis of either ET or PD as determined by clinical history * Moderate to severe upper limb tremor 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 * For PD subjects, a score \> 2 on at least one of MDS-UPDRS items 3.15, 3.16 or 3.17 At the Screening Visit, a score of \> 3 on one of the following subject-assessed items of the Bain \& Findley Activities of Daily Living Scale (BF-ADL): Use a spoon to drink soup, Hold a cup of tea, Do up buttons, Do up a zipper, Write a letter * Stable medications for at least 30 days prior to enrollment and the ability to maintain tremor medications throughout the duration of study participation * For PD subjects, able to participate in visits in a practically defined OFF state (withdrawal from all tremor medication for 12 hours prior to study visits) * A wrist circumference of 6.0 - 8.1 inches Exclusion Criteria - Beta Phase B2 * 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
Where it's running
-
Encora Therapeutics
Cambridge, Massachusetts, United States Recruiting
Study contacts
- Principal investigator: Ann Marie Murray, MD — WVU Comprehensive Movement Disorder Clinic
- Study coordinator: Allison Davanzo
- Email: alli@encoratherapeutics.com
- Phone: 855-937-5302
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.