Actively Recruiting
Home Use Study of Targeted Mechanical Stimulation for Tremor Relief
Led by Encora, Inc. · Updated on 2025-11-24
80
Participants Needed
1
Research Sites
73 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Home Use Study of Targeted Mechanical Stimulation for Tremor Relief
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Diagnosis of Essential Tremor or Parkinson's Disease as determined by clinical history or specialist
- Moderate to severe upper limb tremor
- For Beta Phase B2: For Essential Tremor, diagnosis defined as definite or probable ET based on TRIG criteria
- For Beta Phase B2: For Parkinson's Disease, diagnosis by a Movement Disorder Specialist
- For Beta Phase B2: Essential Tremor subjects must have at least one hand with tremor > 2 on specific rating tasks
- For Beta Phase B2: Parkinson's Disease subjects must score > 2 on specific MDS-UPDRS items and > 3 on certain daily living activities
- Stable tremor medications for at least 30 days prior and ability to maintain during study
- For Parkinson's Disease subjects in Beta Phase B2, ability to participate in visits in an OFF medication state
- Wrist circumference of 6.0 to 8.1 inches
You will not qualify if you...
- Pregnant women
- Swollen, infected, inflamed areas, skin eruptions, open wounds, or cancerous lesions at the 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
- Unable to communicate with sponsor, investigator, and study staff
- Any other medical or mental conditions that would make participation unsuitable according to the sponsor or investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Encora Therapeutics
Cambridge, Massachusetts, United States, 02142
Actively Recruiting
Research Team
A
Allison Davanzo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
4
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