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NCT Number: NCT07010705

Digital Measures for Clinical Trial Endpoints in Huntington's Disease

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.

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Key information

Conditions

Huntington Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Chorea Cognition Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dementia Dyskinesias Genetic Diseases, Inborn Healthy Heredodegenerative Disorders, Nervous System Mental Disorders Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location status: Recruiting

Location contact

Sugitha Maheswaran, BS

CONTACT

[email protected]

5857040344

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ActiGraph LEAP

Device

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

Device

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 outcomes

  1. Inter-Method Reliability of Total Time in Chorea (Trunk-Worn vs. Wrist-Worn Device)

    Time frame: 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.

  2. Known Group Validity of Total Time in Chorea (Trunk-Worn Device)

    Time frame: 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.

  3. Known Group Validity of Total Time in Chorea (Wrist-Worn Device)

    Time frame: 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.

  4. Inter-Method Reliability of Stride Time Variability (Trunk-Worn vs. Wrist-Worn Device)

    Time frame: 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.

  5. Known Group Validity of Stride Time Variability (Trunk-Worn Device)

    Time frame: 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.

  6. Known Group Validity of Stride Time Variability (Wrist-Worn Device)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sugitha Maheswaran, BS

CONTACT

[email protected]

5857040344

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • Food and Drug Administration (FDA)

Registry information

Official study title

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

Acronym: MEND-HD

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 8, 2025
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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