About this trial
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.
Eligibility criteria
Qualifiers
Male or female, aged 25-65 years
For HD participants: Genetically diagnosed with HD
Fluent in English (able to speak and read).
Ambulatory without the need for a walking aid.
Disqualifiers
Diagnosis of juvenile-onset HD.
Individuals who are non-ambulatory.
Individuals with a neurological, medical, or psychiatric condition that, in the investigator's judgment, would interfere with safe participation in study activities.
Montreal Cognitive Assessment (MoCA) score of 18 or lower
Trial design
Treatments tested in this trial
- Not listed
Trial groups
Sponsors and collaborators
BioSensics
Lead sponsor
National Center for Advancing Translational Sciences (NCATS)
Collaborator
University of Rochester - CHeT/CTCC
Collaborator
Vanderbilt University Medical Center
Collaborator