Development of the Virtual Unified Huntington's Disease Rating Scale
NCT ID: NCT05748288
Last Updated: 2023-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
60 participants
OBSERVATIONAL
2022-09-22
2023-05-02
Brief Summary
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The purpose of this research study is to determine if a standard HD assessment (the UHDRS®) is as reliable when conducted virtually as it is when conducted at an in-person visit (vUHDRS)
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Detailed Description
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Motor Assessment Cognitive Assessment Behavioral Assessment Independence Scale Functional Assessment Total Functional Capacity (TFC)
This observational study seeks to characterize and compare in-person versus TeleVisits. Fifty percent of participants will be provided computer equipment for their remote assessment and the other 50% will use their existing home-based equipment for this purpose.
TeleVisit is a method for participants to connect to the research study team remotely, via video and audio connection either on their computer or iPad.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Personal Equipment
Participants assigned to use technology they currently own
No interventions assigned to this group
HSG Equipment
Participants provided technology by the sponsor
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Are able and willing to provide written informed consent
3. Are English speaking
4. Currently exhibit motor signs and symptoms of Huntington Disease
5. Have a genetic diagnosis of HD with an expanded CAG repeat (greater than or equal to 36) in the huntingtin (HTT) gene at or before Screening/Baseline visit from a validated laboratory
6. Have oral and written communication skills that are sufficient/adequate to complete all cognitive assessments
7. Are ambulatory, but may use any assistive device or require help
8. Are able to maintain stable medications for 30 days prior to Screening/Baseline through the second in-person visit
9. Have a study partner available to help with technology and set-up and to attend all study visits
10. Have the ability to get email on the device used for the study
Exclusion Criteria
2. Are unable to obtain satisfactory internet connection (i.e., internet connection must be stable and support the audio and video needs without freezing or interruption) at home or designated location, even with provided equipment
3. Have inadequate space at home to assess 10 steps for gait assessments
4. Have active suicidal ideation endorsed with a score of 4 (Active Suicidal Ideation with Some Intent to Act, without Specific Plan) if the ideation occurred within 1 year of Screening or 5 (Active Suicidal Ideation with Specific Plan and Intent) on the C-SSRS if the attempt or acts were performed within 1 year of Screening/Baseline, or participants who, in the opinion of the Site Investigator (SI), present a serious risk of suicide.
5. Have received gene therapy or an investigational drug within 30 days or 5 half-lives, whichever is longer, of the Screening/Baseline visit or plan to use an investigational drug during this study.
18 Years
ALL
No
Sponsors
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Huntington Study Group
NETWORK
Responsible Party
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Principal Investigators
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Samuel Frank, MD
Role: PRINCIPAL_INVESTIGATOR
Huntington Study Group
Jody Goldstein
Role: STUDY_DIRECTOR
Huntington Study Group
Locations
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University of Alabama at Birmingham, Department of Neurology
Birmingham, Alabama, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
University of California, San Diego
La Jolla, California, United States
Georgetown University
Washington D.C., District of Columbia, United States
University of South Florida, Huntington Disease Center of Excellence
Tampa, Florida, United States
Northwestern University Medical Center, Department of Neurology
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
Hereditary Neurological Disease Center
Wichita, Kansas, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Massachusetts General Hospital
Charlestown, Massachusetts, United States
Washington University
St Louis, Missouri, United States
Sanford Brain and Spine Clinic
Fargo, North Dakota, United States
Ohio State University Medical Center
Columbus, Ohio, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
University of Texas, Health Science Center
Houston, Texas, United States
University of Vermont Medical Center
Burlington, Vermont, United States
Countries
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Other Identifiers
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vUHDRS
Identifier Type: -
Identifier Source: org_study_id
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