Digital Measures for Clinical Trial Endpoints in Huntington's Disease

Part of paid clinical trials in Rochester, New York.

Sponsor
University of Rochester
Study ID
NCT07010705
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
25 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • ActiGraph LEAP — DEVICE
    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.
  • Axivity AX6 — 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.

Study Details

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.

Key Dates

Start date
Jun 20, 2025
Status verified
May 2025
Primary completion
Jun 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: 20 HD-ISS Stage 2
    (CAG ≥ 40 and sign/symptom of HD) with or without a support person or family member
  • Arm: 20 HD-ISS mild or moderate Stage 3
    (CAG ≥40 and sign symptom and functional impact) with or without a support person or family member
  • Arm: 20 Healthy controls
    age and sex-matched

Primary Outcome Measure

Inter-Method Reliability of Total Time in Chorea (Trunk-Worn vs. Wrist-Worn Device) [ Time Frame: 1 week ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Rochester Medical CenterRochesterNew York14642
Sugitha Maheswaran, BS
[email protected]
5857040344

Find similar trials in Rochester, NY

By condition
Huntington disease
By specialty
NeurologyBrain disorders
By research site
University of Rochester Medical Center· Rochester, NY

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