Clinical trial NCT07010705: Digital Measures for Clinical Trial Endpoints in Huntington's Disease
Official title: Digital Measures for Clinical Trial Endpoints in Huntington's Disease (MEND-HD)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Huntington Disease
Healthy
Keywords: Huntington Disease
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Food and Drug Administration (FDA)
First posted: 2025-06-08
Enrollment: 100
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will enroll 60 participants: 20 HD-ISS Stage 2 (CAG ≥ 40 and sign/symptom of HD) with or without a support person or family member; 20 HD-ISS early Stage 3 (CAG ≥ 40 and sign symptom and functional impact) with or without a support person or family member; and 20 controls (age and sex-matched). Participants will not be excluded based on ethnicity, and no subpopulations will be excluded from this study. We will exert specific efforts to ensure the inclusion of minorities, including the Black and Hispanic populations

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.


Eligibility criteria: Inclusion Criteria:

* Inclusion Criteria for participants with adult-onset HD:
* Age of 25-60 years.
* Genetically confirmed HD (HD-ISS Stage 2 or early Stage 3)
* English speaking.

Inclusion Criteria for control participants:

* Age of 25-60 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

Primary outcomes:
measure: Inter-Method Reliability of Total Time in Chorea (Trunk-Worn vs. Wrist-Worn Device)
timeFrame: 1 week
measure: Known Group Validity of Total Time in Chorea (Trunk-Worn Device)
timeFrame: 1 week
measure: Known Group Validity of Total Time in Chorea (Wrist-Worn Device)
timeFrame: 2 weeks
measure: Inter-Method Reliability of Stride Time Variability (Trunk-Worn vs. Wrist-Worn Device)
timeFrame: 1 week
measure: Known Group Validity of Stride Time Variability (Trunk-Worn Device)
timeFrame: 1 week
measure: Known Group Validity of Stride Time Variability (Wrist-Worn Device)
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
References: