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

About this trial

Last updated 5 months ago

Study ID

BioDigit HD-02

Status

Not yet recruiting

Type

Observational

Placebo

Accepting

25 to 65 Years

All Sexes

Trial Timing

Started 4 months ago

What is this trial about?

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.

What are the participation requirements?

Inclusion Criteria

* 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. * Able to independently perform all study activities safely, as determined by the investigator. * Willing and able to provide informed consent and comply with all study procedures. For control participants: * Male or female, aged 25-65 years * Clinically assessed to be in good health, with no evidence of neurological disorders that could cause involuntary movements or gait disturbances

Exclusion Criteria

* 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 * Pregnant individuals, due to potential changes in gait and physical activity during pregnancy. * Cannot be enrolled into a blinded intervention trial at baseline.