Huntington DiseaseMEND-HDNCT07010705
Digital Measures for Clinical Trial Endpoints in Huntington's Disease
An observational study of Huntington Disease and Healthy, run by University of Rochester at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Huntington Disease, Healthy
- What is being tested?
- ActiGraph LEAP and Axivity AX6
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2025to 30 Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study 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
Who may be able to join
- 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.
- English speaking.
- Self-identified support person or family member of the enrolled participants with HD.
- 18 years or older
- English speaking.
Who cannot join
- 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,
Show all 9Show fewer
- cardiovascular or psychiatric disease.
- Pregnancy
- Cannot be enrolled into a blinded intervention trial at Baseline
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Rochester Medical Center
Rochester, New York, 14642
Sugitha Maheswaran, BS, 5857040344, sugi_maheswaran@urmc.rochester.edu
About this study
Official title: Digital Measures for Clinical Trial Endpoints in Huntington's Disease (MEND-HD)
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.
Read more
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.
- Conditions
- Huntington Disease, Healthy
- Being tested
- ActiGraph LEAP, Axivity AX6
- Keywords
- Huntington Disease
- Medical subject headings
- Huntington Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActiGraph LEAPDevice
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 AX6Device
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.
| Study group | Role | What they receive |
|---|---|---|
| 20 HD-ISS Stage 2 | (CAG ≥ 40 and sign/symptom of HD) with or without a support person or family member Receives: Device: ActiGraph LEAP; Device: Axivity AX6 | |
| 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 Receives: Device: ActiGraph LEAP; Device: Axivity AX6 | |
| 20 Healthy controls | age and sex-matched Receives: Device: ActiGraph LEAP; Device: Axivity AX6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week
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.
Measured: 1 week
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.
Measured: 2 weeks
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.
Measured: 1 week
Known Group Validity of Stride Time Variability (Trunk-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 ability of the trunk-worn device to differentiate between HD and control participants.
Measured: 1 week
Known Group Validity of Stride Time Variability (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 ability of the wrist-worn device to differentiate between HD and control participants.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start20 Jun 2025
- Primary completion31 Aug 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Huntington DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Food and Drug Administration (FDA)
- Responsible party
- Principal investigator, Jamie Adams, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07010705
- Sponsor's protocol ID
- STUDY00010159
- Other IDs
- 1U01FD008429-01
- Acronym
- MEND-HD
- Status last verified
- Aug 2026
- First submitted
- 30 May 2025
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Measures for Clinical Trial Endpoints in Huntington's Disease (MEND-HD)
- ClinicalTrials.gov ID
- NCT07010705
- Acronym / sponsor ID
- MEND-HD / STUDY00010159
- Conditions
- Huntington Disease, Healthy
- Keywords
- Huntington Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Food and Drug Administration (FDA)
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 8 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 20 HD-ISS Stage 2 | – | Device: ActiGraph LEAP, Device: Axivity AX6(CAG ≥ 40 and sign/symptom of HD) with or without a support person or family member |
| 20 HD-ISS mild or moderate Stage 3 | – | Device: ActiGraph LEAP, Device: Axivity AX6(CAG ≥40 and sign symptom and functional impact) with or without a support person or family member |
| 20 Healthy controls | – | Device: ActiGraph LEAP, Device: Axivity AX6age and sex-matched |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study 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
Key inclusion criteria (8 listed)
- 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.
- English speaking.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ActiGraph LEAPThe 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 | 20 HD-ISS Stage 2, 20 HD-ISS mild or moderate Stage 3, 20 Healthy controls |
| Axivity AX6The 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. | Device | 20 HD-ISS Stage 2, 20 HD-ISS mild or moderate Stage 3, 20 Healthy controls |
Primary outcome
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.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Huntington Disease and Healthy, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sugitha Maheswaran, BS (5857040344, Sugi_maheswaran@urmc.rochester.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inter-Method Reliability of Total Time in Chorea (Trunk-Worn vs. Wrist-Worn Device) (time frame: 1 week). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.