Multi-Modal Digital Monitoring of Disease Symptoms Huntington's Disease
Part of paid clinical trials in Rochester, New York.
- Sponsor
- BioSensics
- Study ID
- NCT07315984
- Status
- Not Yet Recruiting
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Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 25 Years - 65 Years
- Healthy Volunteers
- Accepted
Study Details
The objective of the study is to validate the use of wearable sensors and digital health technologies for monitoring disease activity in Huntington's Disease (HD). Healthy subjects, as well as subjects with documented diagnosis of HD will be screened and recruited at University of Rochester Medical Center and Vanderbilt University Medical Center to participate in this 12-month observational study. There will be a total of 5 visits every approximately 3 months. In each study visit, participants will complete several Patient Reported Outcomes (PROs), Clinical Reported Outcomes, complete a series of Digital Assessments (Speech, Cognitive, Motor, and Finger Tapping). Participants will be provided with a pendant, wrist, and ankle sensors to monitor their daily physical activities for 7 days after each study visit. Participants will also be provided with a tablet to complete digital assessments (Speech, Cognitive, Motor, and Finger Tapping) on monthly basis at home.
Key Dates
- Start date
- Jan 31, 2026
- Status verified
- Dec 2025
- Primary completion
- Aug 31, 2028
- Completion
- Dec 31, 2028
Study Design
- Enrollment
- 75 participants (estimated)
Arms
- Arm: Hungtinton's DiseaseParticipants with clinical diagnosis of HD
- Arm: Age-matched healthy adultsAge-matched healthy adults. Clinically assessed to be in good health, with no evidence of neurological disorders that could cause involuntary movements or gait disturbances.
Primary Outcome Measure
Change in daily walking duration during activities of daily living from baseline to 12 months as measured by the PAMSys pendant [ Time Frame: 12 months ]
Central Contacts
- Ana Enriquez888-589-6213
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Rochester Medical Center | Rochester | New York | 14642 | Jamie Adams, MD Jamie Adams, MD (PRINCIPAL_INVESTIGATOR) |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | Daniel Claassen, MD Daniel Claassen (PRINCIPAL_INVESTIGATOR) |
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