Digital Measures for Clinical Trial Endpoints in Huntington's Disease (MEND-HD)

University of Rochester

Status: Enrolling

Conditions: Healthy; Huntington Disease

Treatments: Device: Axivity AX6; Device: ActiGraph LEAP

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT07010705

1U01FD008429-01 (U.S. FDA Grant/Contract)

STUDY00010159

Details and patient eligibility

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 25 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

100 participants in 3 patient groups

20 HD-ISS Stage 2

Description:

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

Treatment:

Device: ActiGraph LEAP

Device: Axivity AX6

20 HD-ISS mild or moderate Stage 3

Description:

(CAG ≥40 and sign symptom and functional impact) with or without a support person or family member

Treatment:

Device: ActiGraph LEAP

Device: Axivity AX6

20 Healthy controls

Description:

age and sex-matched

Treatment:

Device: ActiGraph LEAP

Device: Axivity AX6