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

Study acronym: BioDigit HD-02
StatusNot Yet Recruiting
PhaseNot specified
SponsorBioSensics
Started
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Record History

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  1. Start date: Jan 31, 2026 to Jan 31, 2027
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: details revised at 4 of 5 entries
    • Collaborators: details revised at 1 of 3 entries
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
BioSensics
8 trials monitored
See 1 trial at risk
Dementia
1,978 trials monitored
See 106 trials at risk
Huntington's Disease
81 trials monitored
See 4 trials at risk
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
(from sponsor)		 Huntington Disease
Related terms Huntington Disease
Enrollment 75 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov