Digital Measures for Clinical Trial Endpoints in Huntington's Disease
This observational study, called MEND-HD, is looking at how well digital devices can measure movement changes in people with Huntington's Disease (HD) and healthy individuals. Researchers are using two devices, ActiGraph LEAP and Axivity AX6, to continuously track activity, sleep, and mobility. The study aims to see if these devices can reliably measure chorea (involuntary movements) and if these measurements are meaningful to people with HD and their caregivers. You may be able to join if you are between 25 and 65 years old and speak English. For those with HD, you need to have a genetic confirmation of HD with a specific CAG repeat number. The study will look at how consistently the devices measure chorea and if these measurements accurately reflect known differences between people with and without HD.
- Study design
- This is an observational study planning to enroll 100 participants. It is not a treatment study but rather observes and collects data.
- What's involved
- You will have four virtual visits where you answer surveys, perform in-home movement assessments, and participate in an interview about daily life with gait and chorea. The study may extend to 3 years with yearly visits.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoints are measured at 1 week and 2 weeks. The study may be extended to 3 years to include yearly visits.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Digital Measures for Clinical Trial Endpoints in Huntington's Disease
At a glance
Conditions
NCT07010705
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
University of Rochester Medical Center
Rochester, New Yorkstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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Inclusion
Exclusion
What this trial measures
- Inter-Method Reliability of Total Time in Chorea (Trunk-Worn vs. Wrist-Worn Device)1 week
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.
- Known Group Validity of Total Time in Chorea (Trunk-Worn Device)1 week
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.
- Known Group Validity of Total Time in Chorea (Wrist-Worn Device)2 weeks
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.
- Inter-Method Reliability of Stride Time Variability (Trunk-Worn vs. Wrist-Worn Device)1 week
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.
- Known Group Validity of Stride Time Variability (Trunk-Worn Device)1 week
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 ability of the trunk-worn device to differentiate between HD and control participants.
- Known Group Validity of Stride Time Variability (Wrist-Worn Device)2 weeks
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 ability of the wrist-worn device to differentiate between HD and control participants.