Recruiting

Observational Study

Sponsor:

Stanford University

Code:

NCT06941662

Conditions

Huntington Disease

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

computer vision, remote monitoring, blood, urine, wrist bands, mobile-app

Study Details

Brief 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 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

Study ID

NCT06941662

Start date

Jun 1, 2024

Status verified date

Apr, 2025

Completion date

Dec, 2035

Anticipated

Primary completion date

Dec, 2035

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Individuals with a positive test for the HD expansion mutation.

Exclusion Criteria:

  • Individuals with movement disorders with a negative test for the HD expansion mutation.

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

Huntington's disease

Individuals who carry the Huntington's disease mutation. Individuals with pre-manifest or manifest disease at all disease stages are welcome

Interventions

computer vision, remote monitoring, blood, urine, wrist bands, mobile-app

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.

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) ]

Central Contacts and Locations

Central contacts

Minhtrang Chu, Study Coordinator

650-250-3160mtchu@stanford.edu

Olivia Lu, Study Coordinator

650-374-9286olivialu@stanford.edu

Locations

Stanford University

Recruiting

Palo Alto, California, United States, 94304

Contacts

Minhtrang Chu, Study Coordinator

650-250-3160mtchu@stanford.edu

Olivia Lu, Study Coordinator

650-374-9286olivialu@stanford.edu

Principal Investigator:

Kyan Younes, MD

More Information

Sponsor

Stanford University

Last update posted

Apr 24, 2025

Last verified

Apr, 2025

Keywords

  • Huntington's disease biomarkers
  • remote monitoring
  • biobank
  • observational study

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2025-04-24.