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Recruiting NCT07010705

Digital Measures for Clinical Trial Endpoints in Huntington's Disease

— Observational Huntington Disease Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ActiGraph LEAP, Axivity AX6.
Who it may be relevant to
Registry conditions: Huntington Disease, Healthy. Basic parameters: 25 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Digital Measures for Clinical Trial Endpoints in Huntington's Disease (MEND-HD)

Overview

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.

Interventions

  • Device 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.
  • 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.

Primary outcome measures

  • Inter-Method Reliability of Total Time in Chorea (Trunk-Worn vs. Wrist-Worn Device) [Time frame: 1 week]
  • Known Group Validity of Total Time in Chorea (Trunk-Worn Device) [Time frame: 1 week]
  • Known Group Validity of Total Time in Chorea (Wrist-Worn Device) [Time frame: 2 weeks]
  • Inter-Method Reliability of Stride Time Variability (Trunk-Worn vs. Wrist-Worn Device) [Time frame: 1 week]
  • Known Group Validity of Stride Time Variability (Trunk-Worn Device) [Time frame: 1 week]
  • Known Group Validity of Stride Time Variability (Wrist-Worn Device) [Time frame: 2 weeks]

Eligibility criteria

Inclusion criteria

Inclusion Criteria for participants with adult-onset HD:

  • Age of 25-65 years.
  • Genetically confirmed HD with CAG >= 40 (HD-ISS Stage 2 or mild/moderate Stage 3)
  • English speaking.

Inclusion Criteria for control participants:

  • Age of 25-65 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

United States · 1 center
  • University of Rochester Medical Center — Rochester

Identifiers

NCT: NCT07010705 · STUDY00010159 · 1U01FD008429-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗