Digital Measures for Clinical Trial Endpoints in Huntington's Disease
Digital Measures for Clinical Trial Endpoints in Huntington's Disease (MEND-HD)
University of Rochester
100 participants
Jun 20, 2025
OBSERVATIONAL
Conditions
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
Inclusion Criteria8
- Age of 25-65 years.
- Genetically confirmed HD with CAG >= 40 (HD-ISS Stage 2 or mild/moderate Stage 3)
- English speaking.
- Age of 25-65 years.
- English speaking.
- Self-identified support person or family member of the enrolled participants with HD.
- years or older
- English speaking.
Exclusion Criteria9
- 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
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Interventions
The ActiGraph LEAP has received 510(k) clearance from the US FDA and offers extensive sensor collections, providing continuous digital measures of activity, sleep, mobility, and additional vital signs, including heart rate and variability, oxygen saturation, and skin temperature, in a single fit-for-purpose device.
The Axivity AX6 is a data logger capable of recording raw data from a suite of integrated sensors. It features a state of the art 6-Axis movement sensor measuring linear acceleration and angular velocity at high precision. All sensor locations and Orientations are identical to the AX3 for maximum compatibility. All data is stored in its raw, unaltered format on the embedded flash memory.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07010705