Digital Measures for Clinical Trial Endpoints in Huntington's Disease

Not yet recruiting

• Conditions: Huntington Disease; Healthy

• Registration Number: NCT07010705
• Lead Sponsor: University of Rochester

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-30
• Study First Submitted QC: 2025-05-30
• Last Update Submitted: 2025-05-30
• Study Start: 2025-06
• Study First Posted: 2025-06-08
• Last Update Posted: 2025-06-08
• Primary Completion: 2026-06-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Inclusion Criteria for participants with adult-onset HD:
• Age of 25-60 years.
• Genetically confirmed HD (HD-ISS Stage 2 or early Stage 3)
• English speaking.

Inclusion Criteria for control participants:

• Age of 25-60 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Inter-Method Reliability of Total Time in Chorea (Trunk-Worn vs. Wrist-Worn Device)	1 week	Total time in chorea is calculated by summing the duration of all bouts of detected chorea throughout each day and then summed across the week (normalized to wear time). The outcome will assess the ability of the wrist-worn device to differentiate between HD and control participants.
Known Group Validity of Total Time in Chorea (Trunk-Worn Device)	1 week	Total time in chorea is calculated by summing the duration of all bouts of detected chorea throughout each day and then summed across the week (normalized to wear time). The outcome will assess the ability of the wrist-worn device to differentiate between HD and control participants.
Known Group Validity of Total Time in Chorea (Wrist-Worn Device)	2 weeks	Total time in chorea is calculated by summing the duration of all bouts of detected chorea throughout each day and then summed across the week (normalized to wear time). The outcome will assess the ability of the wrist-worn device to differentiate between HD and control participants.
Inter-Method Reliability of Stride Time Variability (Trunk-Worn vs. Wrist-Worn Device)	1 week	Stride time variability is defined as the coefficient of variation of stride time, with the median value calculated across all walking bouts lasting at least 10 seconds. The outcome will assess the agreement between trunk-worn and wrist-worn devices among HD and control participants.
Known Group Validity of Stride Time Variability (Trunk-Worn Device)	1 week	Stride time variability is defined as the coefficient of variation of stride time, with the median value calculated across all walking bouts lasting at least 10 seconds. The outcome will assess the ability of the trunk-worn device to differentiate between HD and control participants.
Known Group Validity of Stride Time Variability (Wrist-Worn Device)	2 weeks	Stride time variability is defined as the coefficient of variation of stride time, with the median value calculated across all walking bouts lasting at least 10 seconds. The outcome will assess the ability of the wrist-worn device to differentiate between HD and control participants.

Trial Locations

Locations (1)

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States