Digital Measures for Clinical Trial Endpoints in Huntington's Disease
NCT ID: NCT07010705
Last Updated: 2026-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2025-06-20
2026-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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20 HD-ISS Stage 2
(CAG ≥ 40 and sign/symptom of HD) with or without a support person or family member
ActiGraph LEAP
The 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
The 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.
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
ActiGraph LEAP
The 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
The 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.
20 Healthy controls
age and sex-matched
ActiGraph LEAP
The 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
The 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.
Interventions
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ActiGraph LEAP
The 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
The 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.
Eligibility Criteria
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Inclusion Criteria
* Genetically confirmed HD with CAG \>= 40 (HD-ISS Stage 2 or mild/moderate Stage 3)
* English speaking.
* Age of 25-65 years.
* English speaking.
* Self-identified support person or family member of the enrolled participants with HD.
* 18 years or older
* English speaking.
Exclusion Criteria
* 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
25 Years
65 Years
ALL
Yes
Sponsors
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Food and Drug Administration (FDA)
FED
University of Rochester
OTHER
Responsible Party
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Jamie Adams
Associate Professor - Department of Neurology
Locations
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University of Rochester Medical Center
Rochester, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STUDY00010159
Identifier Type: -
Identifier Source: org_study_id
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