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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age25-65
SponsorBioSensics

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

75 Participants
are grouped into 2 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