Home Use Study of a Device for Tremor Relief in Tremor Patients
Tests a home-use device for tremor in adults with essential tremor or Parkinson disease.
Key facts
- Who runs it
- Encora, Inc.
- Where
- Cambridge, United StatesSee the site
- Trial code
- Registry title
- Home Use Study of Targeted Mechanical Stimulation for Tremor Relief
- Status
- Recruiting
- People taking part
- 80 people, planned
- Started
- 1 Jan 2025
- Planned end
- Jun 2026
- Type of study
- Interventional, 4 groups
- Treatments tested
- Encora Pulse
- Record updated
- 24 November 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with essential tremor or Parkinson's disease who have moderate to severe tremor in the arm or hand. They test a wrist device at home.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Essential tremor or Parkinson's disease, with moderate to severe upper limb tremor. In the 12-week phase (Beta Phase B2), essential tremor must be definite or probable by TRIG criteria. Parkinson's disease must be diagnosed by a Movement Disorder Specialist.
- Earlier treatment
- In the 12-week phase (Beta Phase B2), people must have taken stable medications for at least 30 days before joining. They must keep their tremor medications unchanged during the trial. Parkinson's patients must stop all tremor medication for 12 hours before study visits.
- Biomarker or test result
- In the 12-week phase (Beta Phase B2), tremor scores must meet set levels on the TETRAS scale (essential tremor) or the MDS-UPDRS (Parkinson's). A wrist circumference of 6.0 - 8.1 inches is also needed.
Main reasons for not taking part
- Pregnant women
- Swollen, infected or inflamed skin, rashes, open wounds or skin cancer where the device sits
- History of psoriasis, eczema or atopic dermatitis where the device sits
- Peripheral neuropathy in the arms or hands, including carpal tunnel syndrome and diabetic neuropathy
- Cannot communicate with the study team
The registry criteria, word for word
Show all 25 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Pregnant women
- Participant unable to communicate with sponsor/investigator and staff
- Pregnant women
- Participant unable to communicate with sponsor/investigator and staff
Where in United States
- Encora TherapeuticsCambridge, United StatesContact: Allison DavanzoTaking people
About the trial
What the trial wants to find out
Subjects will receive prototype devices to be used for participation. The study comprises three phases:
Read full original descriptionShow less
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.
The 4 groups in the trial
- ATreatment being tested
Oder of assessment begins with TETRAS and ends with ADLs
Treatment: Encora Pulse
- BTreatment being tested
Order of assessment begins with ADLs and ends with TETRAs
Treatment: Encora Pulse
- CTreatment being tested
Order of assessment begins with TETRAS and ends with ADLs, but both are administered backwards
Treatment: Encora Pulse
- DTreatment being tested
Order of assessment begins with ADLs and ends with TETRAs, but both are administered backwards
Treatment: Encora Pulse
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Home Use Study of Targeted Mechanical Stimulation for Tremor Relief
- Plain-language title
- Home Use Study of a Device for Tremor Relief in Tremor PatientsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 24 November 2025