Actively Recruiting
Digital Measures for Clinical Trial Endpoints in Huntington's Disease (MEND-HD)
Led by University of Rochester · Updated on 2026-01-27
100
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
U
University of Rochester
Lead Sponsor
F
Food and Drug Administration (FDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of digital devices to passively monitor walking patterns and involuntary movements called chorea in adults with Huntington's Disease (HD). This observational study aims to determine how meaningful these digital measurements are for patients with HD and their care partners. The study involves participants with genetically confirmed adult-onset HD as well as healthy controls, with possible extension to yearly visits over three years. Participants will use wearable devices, including the ActiGraph LEAP and Axivity AX6, which collect continuous data on movement, sleep, heart rate, and other vital signs. The study groups include HD patients at different disease stages and healthy controls. Study visits are virtual and involve surveys on movement and cognition, in-home movement assessments, and interviews about how gait and chorea affect daily life. During the study, participants and their care partners will complete four virtual visits to answer questions, perform movement tasks, and share their experiences. Researchers will analyze interviews for symptom impact and compare device data for reliability and validity of measuring chorea and stride time variability. The total participation time varies, with possible study extension to three years involving annual visits to monitor these digital measures and their relevance to daily living.
CONDITIONS
Brief Title
Digital Measures for Clinical Trial Endpoints in Huntington's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age of 25-65 years
- Genetically confirmed adult-onset Huntington's Disease with CAG 40 or higher (HD-ISS Stage 2 or mild/moderate Stage 3) for HD participants
- English speaking
- Age of 25-65 years for healthy control participants
- Self-identified support person or family member of enrolled HD participants
- Support persons must be 18 years or older
- Support persons must be English speaking
You will not qualify if you...
- Diagnosis of juvenile-onset Huntington's Disease
- History of other neurological diseases such as stroke or multiple sclerosis
- History of moderate to severe traumatic brain injury
- Use of assistive devices for walking
- Montreal Cognitive Assessment (MoCA) score of 18 or lower
- Acute or chronic medical conditions significantly affecting gait or mobility, including orthopedic, cardiovascular, or psychiatric diseases
- Pregnancy
- Enrollment in a blinded intervention trial at baseline
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.
Duration - 1 to 2 weeks
Participants wear digital devices that continuously record activity, sleep, mobility, and vital signs.
Wear devices for 1 to 2 weeks
Trial Site Locations
Total: 1 location
1
University of Rochester Medical Center
Rochester, New York, United States, 14642
Actively Recruiting
Research Team
S
Sugitha Maheswaran, BS
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here