NCT07078422Recruiting
Home Use Study of Targeted Mechanical Stimulation for Tremor Relief
Source: ClinicalTrials.gov · Last updated 24 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 9 Apr 2025
- Start date
- 1 Jan 2025
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Encora, Inc.
- Diseases
- Parkinson disease
- NCT number
- NCT07078422
What you commit to
- Study type: Interventional
- Planned participants: 80
- From 1 Jan 2025 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
- 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.
- 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
- 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
Other
- Pregnant women
- Participant unable to communicate with sponsor/investigator and staff
- Pregnant women
- Participant unable to communicate with sponsor/investigator and staff
Who the study is looking for
- 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
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Encora Therapeutics Coordinator of this site? Confirm its status | Cambridge | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.