[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06941662":3,"trial-entities:NCT06941662":90,"trial-summary:NCT06941662":95},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":25,"primary_purpose":17,"phases":26,"enrollment_info":27,"interventions":30,"primary_outcomes":37,"secondary_outcomes":42,"sex":49,"minimum_age":17,"maximum_age":17,"healthy_volunteers":50,"eligibility_criteria":51,"std_ages":57,"locations":61,"central_contacts":83,"overall_officials":86,"references":88,"see_also_links":89},"NCT06941662","74659","Huntington's Disease Biobank: Advancing Remote Monitoring and Deep Phenotyping","HD Project: Neurodegenerative Disease Research Platform - Novel Remote Monitoring and Deep Phenotyping.","RECRUITING","2035-12","2025-04","2025-04-24","2024-06-01","Stanford University","OTHER",false,"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.\n\nUsing 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.\n\nThe 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.",null,[19],"Huntington Disease",[21,22,23,24],"Huntington's disease biomarkers","remote monitoring","biobank","observational study","OBSERVATIONAL",[],{"count":28,"type":29},200,"ESTIMATED",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DIAGNOSTIC_TEST","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.",[36],"Huntington's disease",[38],{"measure":39,"description":40,"timeFrame":41},"Unified Huntington's Disease Rating Scale (UHDRS)","Neurological exam with a neurologist to document the motor exam","Once a year in-person and 3 times a year remotely, until death or dropout of the study (average approximately 1 year)",[43,46],{"measure":44,"description":45,"timeFrame":41},"Timed Up and Go (TUG)","Timed stand from chair and walk",{"measure":47,"description":48,"timeFrame":41},"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,","ALL",true,{"inclusion":52,"exclusion":54,"raw_text":56},[53],"Individuals with a positive test for the HD expansion mutation.",[55],"Individuals with movement disorders with a negative test for the HD expansion mutation.","Inclusion Criteria:\n\n* Individuals with a positive test for the HD expansion mutation.\n\nExclusion Criteria:\n\n* Individuals with movement disorders with a negative test for the HD expansion mutation.",[58,59,60],"CHILD","ADULT","OLDER_ADULT",[62],{"facility":13,"status":8,"city":63,"state":64,"zip":65,"country":66,"contacts":67,"geoPoint":80},"Palo Alto","California","94304","United States",[68,73,77],{"name":69,"role":70,"phone":71,"email":72},"Minhtrang Chu, Study Coordinator","CONTACT","650-250-3160","mtchu@stanford.edu",{"name":74,"role":70,"phone":75,"email":76},"Olivia Lu, Study Coordinator","650-374-9286","olivialu@stanford.edu",{"name":78,"role":79},"Kyan Younes, MD","PRINCIPAL_INVESTIGATOR",{"lat":81,"lon":82},37.44188,-122.14302,[84,85],{"name":69,"role":70,"phone":71,"email":72},{"name":74,"role":70,"phone":75,"email":76},[87],{"name":78,"affiliation":13,"role":79},[],[],{"nct_id":4,"conditions":91,"biomarkers":93},[92],"Huntington's Disease",[94],"HTT Gene",{"nct_id":4,"found":50,"summary":96,"prompt_version":105},{"design":97,"status":98,"heading":6,"summary":99,"follow_up":100,"word_count":101,"commitments":102,"compensation":103,"drugs_mentioned":104},"This is an observational study, meaning it watches and collects information without giving a specific treatment. It aims to enroll 200 participants.","completed","This observational study is looking for people with Huntington's disease (HD) to help researchers understand how the disease starts and changes over time. It uses a combination of remote monitoring tools like computer vision (analyzing videos of movement), mobile apps for thinking skills, and wearable wrist bands. You would also provide blood and urine samples. The goal is to find new ways to track HD progression from your home, making it easier to evaluate symptoms. Researchers will track your disease progression and compare these digital markers with changes in your blood and cerebrospinal fluid. The study plans to enroll 200 participants.","Participants will be followed until death or dropout, with an average follow-up of approximately one year.",101,"You would have an in-person evaluation once a year and remote evaluations three times a year. You would also provide blood and urine samples, and use wrist bands and a mobile app.","Not stated in the trial record.",[],"v2"]