NCT07010705 Digital Measures for Clinical Trial Endpoints in Huntington's Disease
| NCT ID | NCT07010705 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Rochester |
| Condition | Huntington Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-06-20 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2025-06-20 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. The study may be extended to 3 years to include yearly visits.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07010705 clinical trial?
This trial is open to participants of all sexes, aged 25 Years or older, up to 65 Years, studying Huntington Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07010705 currently recruiting?
Yes, NCT07010705 is actively recruiting participants. Contact the research team at Sugi_maheswaran@urmc.rochester.edu for enrollment information.
Where is the NCT07010705 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT07010705 clinical trial?
NCT07010705 is sponsored by University of Rochester. The trial plans to enroll 100 participants.