Digital Measures for Clinical Trial Endpoints in Huntington's Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age25-65
SponsorUniversity of Rochester
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- ActiGraph LEAP
- Axivity AX6
Treatment groups
100 Participants
are divided into 3 treatment groupsSponsors and collaborators
University of Rochester
Lead sponsor
Food and Drug Administration (FDA)
Collaborator
Source ClinicalTrials.gov