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 Disease
    Participants with clinical diagnosis of HD
  • Arm: Age-matched healthy adults
    Age-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

Locations (2)

FacilityCityStateZIPSite coordinators
University of Rochester Medical CenterRochesterNew York14642
Jamie Adams, MD
Jamie Adams, MD (PRINCIPAL_INVESTIGATOR)
Vanderbilt University Medical CenterNashvilleTennessee37212
Daniel Claassen, MD
Daniel Claassen (PRINCIPAL_INVESTIGATOR)

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