Wearable sensors to track walking and involuntary movements in Huntington's disease
Digital Measures for Clinical Trial Endpoints in Huntington's Disease (MEND-HD)
This study will try whether wrist and body-worn sensors plus virtual visits can track gait changes and chorea in adults with Huntington's disease and in healthy adults.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 25 Years to 65 Years |
| Sex | All |
| Sponsor | University of Rochester Academic / other |
| Locations | 1 site (Rochester, New York) |
| Trial ID | NCT07010705 on ClinicalTrials.gov |
What this trial studies
This longitudinal observational study uses wearable devices (ActiGraph LEAP and Axivity AX6) to passively monitor gait and chorea over repeated virtual visits. Participants complete four virtual visits with survey questions about movement and cognition, perform in-home movement assessments, and join interviews about how gait and chorea affect daily life. Care partners also take part in interviews to map symptoms and provide qualitative context about meaningful impacts. The protocol may be extended to annual visits for up to three years to examine change over time.
Who should consider this trial
Good fit: Ideal candidates are English-speaking adults aged 25–65 with genetically confirmed adult-onset HD (CAG ≥ 40, early-to-moderate stage) who can ambulate without assistive devices, along with age-matched healthy volunteers and support persons.
Not a fit: Patients unlikely to benefit include those with juvenile-onset HD, significant co-morbid neurological or orthopedic conditions, use of ambulatory assistive devices, notable cognitive impairment (MoCA ≤18), pregnancy, or non-English speakers.
Why it matters
Potential benefit: If successful, the approach could provide objective, home-based measures of gait and chorea that help track disease progression and inform treatment decisions.
How similar studies have performed: Prior pilot work using wearable sensors in Huntington's disease and other movement disorders has shown promising signals for gait and involuntary movement detection but remains exploratory and not yet a validated regulatory endpoint.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Inclusion Criteria for participants with adult-onset HD: * Age of 25-65 years. * Genetically confirmed HD with CAG \>= 40 (HD-ISS Stage 2 or mild/moderate Stage 3) * English speaking. Inclusion Criteria for control participants: * Age of 25-65 years. * English speaking. Inclusion Criteria for support persons: * Self-identified support person or family member of the enrolled participants with HD. * 18 years or older * English speaking. Exclusion Criteria: * Diagnosis of juvenile-onset HD. * History of co-morbid neurological disease or disorders such as stroke, multiple sclerosis, or moderate to severe * Traumatic Brain Injury. * Use of an assistive device for ambulation. * Montreal Cognitive Assessment (MoCA) score of 18 or lower * Acute or chronic medical conditions that significantly impact gait or mobility in the opinion of the investigator, e.g. ankle sprain or fracture, or any orthopedic, * cardiovascular or psychiatric disease. * Pregnancy * Cannot be enrolled into a blinded intervention trial at Baseline
Where this trial is running
Rochester, New York
- University of Rochester Medical Center — Rochester, New York, United States (Recruiting)
Study contacts
- Study coordinator: Sugitha Maheswaran, BS
- Email: Sugi_maheswaran@urmc.rochester.edu
- Phone: 5857040344
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.