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
This trial accepts healthy volunteersQualifiers
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 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 mild or moderate 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
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
ActiGraph LEAP
DeviceThe 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
DeviceThe 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.
Treatment groups
100 Participants
are divided into 3 treatment groupsGroup A: 20 HD-ISS Stage 22 interventions
Group B: 20 HD-ISS mild or moderate Stage 32 interventions
Group C: 20 Healthy controls2 interventions
Trial outcomes
Primary outcomes
1
Inter-Method Reliability of Total Time in Chorea (Trunk-Worn vs. Wrist-Worn Device)
Total time in chorea is calculated by summing the duration of all bouts of detected chorea throughout each day and then summed across the week (normalized to wear time). The outcome will assess the ability of the wrist-worn device to differentiate between HD and control participants.
Time frame
1 week2
Known Group Validity of Total Time in Chorea (Trunk-Worn Device)
Total time in chorea is calculated by summing the duration of all bouts of detected chorea throughout each day and then summed across the week (normalized to wear time). The outcome will assess the ability of the wrist-worn device to differentiate between HD and control participants.
Time frame
1 week3
Known Group Validity of Total Time in Chorea (Wrist-Worn Device)
Total time in chorea is calculated by summing the duration of all bouts of detected chorea throughout each day and then summed across the week (normalized to wear time). The outcome will assess the ability of the wrist-worn device to differentiate between HD and control participants.
Time frame
2 weeks4
Inter-Method Reliability of Stride Time Variability (Trunk-Worn vs. Wrist-Worn Device)
Stride time variability is defined as the coefficient of variation of stride time, with the median value calculated across all walking bouts lasting at least 10 seconds. The outcome will assess the agreement between trunk-worn and wrist-worn devices among HD and control participants.
Time frame
1 weekSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Rochester
Lead sponsor
Food and Drug Administration (FDA)
Collaborator
Source ClinicalTrials.gov