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
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a wristband device called Encora Pulse designed to provide personalized mechanical vibration therapy for people with essential tremor or Parkinson's disease. The study aims to assess the usability and design changes of the device through different phases and to measure its effect on upper limb tremor severity using specific scales. The study is non-invasive and aims to gather data on device performance and user experience in home and clinical settings. The study has three phases: Alpha, Beta Phase B1, and Beta Phase B2. The Alpha phase includes two remote visits and a two-week in-home use period to collect initial usability data. Beta Phase B1 involves two in-person or remote visits lasting 60 to 90 minutes to compare design updates between the alpha and beta devices. Beta Phase B2 lasts 12 weeks and includes seven remote visits and in-home device use to gather detailed data on usability and tremor reduction effectiveness. Participants will complete assessments such as the Essential Tremor Rating Assessment Scale (TETRAS) and the Bain & Findley Activities of Daily Living Scale (BF-ADL) at baseline and multiple time points over the study. Data on tremor reduction and device usability will be collected regularly. The study includes monitoring for safety and participant compliance during device use. Total participation duration depends on the phase but includes remote and in-person visits and continuous home usage periods.
CONDITIONS
Brief 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 and able to comply with all study procedures
- Mentally competent to understand and provide written informed consent
- Diagnosis of essential tremor or Parkinson's disease as determined by clinical history or specialist
- Moderate to severe upper limb tremor
- Stable medications for at least 30 days prior to enrollment and ability to maintain tremor medications during study (Beta Phase B2)
- For essential tremor subjects, tremor score > 2 on TETRAS finger to nose, duck wing, or Archimedes Spiral tasks (Beta Phase B2)
- For Parkinson's disease subjects, score > 2 on specified MDS-UPDRS items and ability to participate in OFF medication state (Beta Phase B2)
- Wrist circumference between 6.0 and 8.1 inches (Beta Phase B2)
You will not qualify if you...
- Pregnant women
- Swollen, infected, inflamed skin, open wounds, or cancerous lesions at stimulation site
- History of psoriasis, eczema, or atopic dermatitis at the stimulation site
- History of peripheral neuropathy in upper limbs, including carpal tunnel syndrome and diabetic neuropathy
- Inability to communicate with sponsor, investigator, or staff
- Any medical or physical or mental condition that makes the participant unsuitable for the study in the opinion of the sponsor or investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 months
Participants use the Encora Pulse wristband device at home, which delivers personalized mechanical stimulation to relieve tremor based on their individual tremor characteristics.
Visits at baseline, week 1, week 2, month 1, month 2, and month 3
Trial Site Locations
Total: 1 location
1
Encora Therapeutics
Cambridge, Massachusetts, United States, 02142
Actively Recruiting
Research Team
A
Allison Davanzo
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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