Clinical Trial

Multi-Modal Digital Monitoring of Disease Symptoms Huntington's Disease

Study acronym: BioDigit HD-02
Not Yet Recruiting
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Summary
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.
Trial Details
NCT Number NCT07315984
Lead Sponsor BioSensics
Collaborators: National Center for Advancing Translational Sciences (NCATS), University of Rochester - CHeT/CTCC, Vanderbilt University Medical Center
Conditions Huntington Disease
Enrollment 75 participants
Start Date 2026-01-31
Primary Completion 2028-08-31 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-01-05