Huntington DiseaseNCT06941662
Huntington's Disease Biobank: Advancing Remote Monitoring and Deep Phenotyping
An observational study of Huntington Disease, run by Stanford University at 1 site in United States.
Trial summary
This observational study aims to identify novel biomarkers of disease onset and progression in Huntington's disease by integrating remote monitoring with fluid biomarkers. Using video-based computer vision and mobile app-based cognitive assessments combined with machine learning algorithms, we aim to develop markers… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Huntington Disease
- What is being tested?
- computer vision, remote monitoring, blood, urine, wrist bands, mobile-app
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2024to Dec 2035
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: community, neurology clinics, hospital, huntington's disease centers of excellence.
Who may be able to join
- Individuals with a positive test for the HD expansion mutation.
Who cannot join
- Individuals with movement disorders with a negative test for the HD expansion mutation.
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
Stanford University
Palo Alto, California, 94304
Minhtrang Chu, Study Coordinator, 650-250-3160, mtchu@stanford.edu
Olivia Lu, Study Coordinator, 650-374-9286, olivialu@stanford.edu
About this study
Official title: HD Project: Neurodegenerative Disease Research Platform - Novel Remote Monitoring and Deep Phenotyping.
This observational study aims to identify novel biomarkers of disease onset and progression in Huntington's disease by integrating remote monitoring with fluid biomarkers. Using video-based computer vision and mobile app-based cognitive assessments combined with machine learning algorithms, we aim to develop markers that can be used by Huntington's disease patients at home.
Using machine learning to analyze videos of movement will capture the movements with an accuracy that will be as good as seeing an expert neurologist. These individualized markers can be followed over time to evaluate symptoms onset and change. The study will track disease progression and correlate these digital markers with changes in plasma and cerebrospinal fluid. The ultimate goal is to advance biomarker discovery and therapeutic development for Huntington's disease.
The study includes one in-person visit per year. A remote visit via Zoom or Facetime (15 min) every three months to record videos of movement. We can also share cutting-edge wristbands and a mobile phone app.
- Conditions
- Huntington Disease
- Being tested
- computer vision, remote monitoring, blood, urine, wrist bands, mobile-app
- Keywords
- Huntington's disease biomarkers, remote monitoring, biobank, observational study
- Medical subject headings
- Huntington Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computer vision, remote monitoring, blood, urine, wrist bands, mobile-appDiagnostic test
This is a low burden study that relies on a combination of cutting edge remote monitoring methods to deliver individualized evaluations to participants in their homes.
| Study group | Role | What they receive |
|---|---|---|
| Huntington's disease | Individuals who carry the Huntington's disease mutation. Individuals with pre-manifest or manifest disease at all disease stages are welcome Receives: Diagnostic Test: computer vision, remote monitoring, blood, urine, wrist bands, mobile-app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unified Huntington's Disease Rating Scale (UHDRS)
Neurological exam with a neurologist to document the motor exam
Measured: Once a year in-person and 3 times a year remotely, until death or dropout of the study (average approximately 1 year)
Secondary outcomes (2)
Timed Up and Go (TUG)
Timed stand from chair and walk
Measured: Once a year in-person and 3 times a year remotely, until death or dropout of the study (average approximately 1 year)
30-second Chair Stand Test
Assesses lower body strength and endurance. Participants are instructed to stand up fully and sit back down as many times as possible within 30 seconds,
Measured: Once a year in-person and 3 times a year remotely, until death or dropout of the study (average approximately 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start1 Jun 2024
- Primary completionDec 2035 (estimated)
- Study completionDec 2035 (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.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Schwab Charitable Fund
- Responsible party
- Principal investigator, Kyan Younes, Stanford University
- Investigators
- Kyan Younes, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06941662
- Sponsor's protocol ID
- 74659
- Status last verified
- Apr 2025
- First submitted
- 2 Apr 2025
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HD Project: Neurodegenerative Disease Research Platform - Novel Remote Monitoring and Deep Phenotyping.
- ClinicalTrials.gov ID
- NCT06941662
- Acronym / sponsor ID
- 74659
- Conditions
- Huntington Disease
- Keywords
- Huntington's disease biomarkers, remote monitoring, biobank, observational study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Schwab Charitable Fund
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- Dec 2035 (estimated)
- Study completion
- Dec 2035 (estimated)
- First posted
- 24 Apr 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.
This observational study aims to identify novel biomarkers of disease onset and progression in Huntington's disease by integrating remote monitoring with fluid biomarkers. Using video-based computer vision and mobile app-based cognitive assessments combined with machine learning algorithms, we aim to develop markers that can be used by Huntington's disease patients at home.
Using machine learning to analyze videos of movement will capture the movements with an accuracy that will be as good as seeing an expert neurologist. These individualized markers can be followed over time to evaluate symptoms onset and change. The study will track disease progression and correlate these digital markers with changes in plasma and cerebrospinal fluid. The ultimate goal is to advance biomarker discovery and therapeutic development for Huntington's disease.
The study includes one in-person visit per year. A remote visit via Zoom or Facetime (15 min) every three months to record videos of movement. We can also share cutting-edge wristbands and a mobile phone app.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Huntington's disease | – | Diagnostic Test: computer vision, remote monitoring, blood, urine, wrist bands, mobile-appIndividuals who carry the Huntington's disease mutation. Individuals with pre-manifest or manifest disease at all disease stages are welcome |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- community, neurology clinics, hospital, huntington's disease centers of excellence.
Key inclusion criteria (1 listed)
- Individuals with a positive test for the HD expansion mutation.
Key exclusion criteria (1 listed)
- Individuals with movement disorders with a negative test for the HD expansion mutation.
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 |
|---|---|---|
| computer vision, remote monitoring, blood, urine, wrist bands, mobile-appThis is a low burden study that relies on a combination of cutting edge remote monitoring methods to deliver individualized evaluations to participants in their homes. | Diagnostic test | Huntington's disease |
Primary outcome
Unified Huntington's Disease Rating Scale (UHDRS)
Time frame: Once a year in-person and 3 times a year remotely, until death or dropout of the study (average approximately 1 year)
Neurological exam with a neurologist to document the motor exam
2 secondary outcomes
Timed Up and Go (TUG)
Time frame: Once a year in-person and 3 times a year remotely, until death or dropout of the study (average approximately 1 year)
30-second Chair Stand Test
Time frame: Once a year in-person and 3 times a year remotely, until death or dropout of the study (average approximately 1 year)
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 24 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Kyan Younes, MD principal investigator
Stanford University
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, run by Stanford University 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 1 inclusion and 1 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 24 Apr 2025. 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 Minhtrang Chu, Study Coordinator (650-250-3160, mtchu@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unified Huntington's Disease Rating Scale (UHDRS) (time frame: Once a year in-person and 3 times a year remotely, until death or dropout of the study (average approximately 1 year)). 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 24 Apr 2025.