NCT07010705RecruitingAccepts Healthy Volunteers

Digital Measures for Clinical Trial Endpoints in Huntington's Disease

University of Rochester

Start Date

6/20/2025

Completion Date

9/30/2026

Summary

MEND-HD is a longitudinal study evaluating the feasibility of passive monitoring of gait and chorea in patients with HD and the meaningfulness of these outcomes for patients with HD and their care partners/support persons. Participants will take part in four virtual visits with study investigators to answer survey questions on movement and cognition, perform in-home movement assessments, and take part in an interview regarding the meaningfulness of gait and chorea in their daily lives. Participant and care partner interviews will be used for symptom mapping and qualitative data analysis to assess the relevance and impact of the targeted symptoms on the participant's daily life. The study may be extended to 3 years to include yearly visits.

Eligibility Criteria

Age Range: 25 years to 65 years

Inclusion Criteria: Inclusion Criteria for participants with adult-onset HD: * Age of 25-65 years. * Genetically confirmed HD with CAG \>= 40 (HD-ISS Stage 2 or mild/moderate Stage 3) * English speaking. Inclusion Criteria for control participants: * Age of 25-65 years. * English speaking. Inclusion Criteria for support persons: * Self-identified support person or family member of the enrolled participants with HD. * 18 years or older * English speaking. Exclusion Criteria: * Diagnosis of juvenile-onset HD. * History of co-morbid neurological disease or disorders such as stroke, multiple sclerosis, or moderate to severe * Traumatic Brain Injury. * Use of an assistive device for ambulation. * Montreal Cognitive Assessment (MoCA) score of 18 or lower * Acute or chronic medical conditions that significantly impact gait or mobility in the opinion of the investigator, e.g. ankle sprain or fracture, or any orthopedic, * cardiovascular or psychiatric disease. * Pregnancy * Cannot be enrolled into a blinded intervention trial at Baseline

Interventions

DEVICE

ActiGraph LEAP

DEVICE

Axivity AX6

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Conditions

Huntington DiseaseHealthy

Locations

University of Rochester Medical Center

Rochester, New York 14642

United States