Digital Measures for Clinical Trial Endpoints in Huntington's Disease
University of Rochester · with Food and Drug Administration (FDA) · NCT07010705
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 25–65 · All sexes
- Healthy volunteers
- Accepted
- Study type
- Observational
- Target enrollment
- 100
- US sites recruiting
- 1
- Study start
- June 20, 2025
- Record last updated
- August 17, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: ActiGraph LEAP; Axivity AX6
Conditions: Huntington Disease; Healthy
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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
Recruiting US locations
University of Rochester Medical Center
Rochester, NY 14642
Site contact: Sugitha Maheswaran, BS · 5857040344 · sugi_maheswaran@urmc.rochester.edu
Study contacts (from the official record)
- Sugitha Maheswaran, BS · 5857040344 · Sugi_maheswaran@urmc.rochester.edu
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