Recruiting

Observational Study

Sponsor:

University of Rochester

Code:

NCT07010705

Conditions

Huntington Disease

Healthy

Eligibility Criteria

Sex: All

Age: 25 - 65

Healthy Volunteers: Accepted

Interventions

ActiGraph LEAP

Axivity AX6

Study Details

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.

Conditions

Huntington Disease

Healthy

Study ID

NCT07010705

Start date

Jun 20, 2025

Status verified date

Aug, 2026

Completion date

Nov 30, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 65

Healthy Volunteers: Accepted

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

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

20 HD-ISS Stage 2

(CAG ≥ 40 and sign/symptom of HD) with or without a support person or family member

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

20 Healthy controls

age and sex-matched

Interventions

ActiGraph LEAP

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

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.

Primary outcome measure

  • Inter-Method Reliability of Total Time in Chorea (Trunk-Worn vs. Wrist-Worn Device) [ Time Frame: 1 week ]
  • Known Group Validity of Total Time in Chorea (Trunk-Worn Device) [ Time Frame: 1 week ]
  • Known Group Validity of Total Time in Chorea (Wrist-Worn Device) [ Time Frame: 2 weeks ]
  • Inter-Method Reliability of Stride Time Variability (Trunk-Worn vs. Wrist-Worn Device) [ Time Frame: 1 week ]
  • Known Group Validity of Stride Time Variability (Trunk-Worn Device) [ Time Frame: 1 week ]
  • Known Group Validity of Stride Time Variability (Wrist-Worn Device) [ Time Frame: 2 weeks ]

Central Contacts and Locations

Central contacts

Sugitha Maheswaran, BS

5857040344Sugi_maheswaran@urmc.rochester.edu

Locations

University of Rochester Medical Center

Recruiting

Rochester, New York, United States, 14642

Contacts

Sugitha Maheswaran, BS

5857040344sugi_maheswaran@urmc.rochester.edu

More Information

Sponsor

University of Rochester

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Keywords

  • Huntington Disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Rochester on 2026-08-17.