Development of the Virtual Unified Huntington's Disease Rating Scale
- Conditions
- Huntington Disease
- Registration Number
- NCT05748288
- Lead Sponsor
- Huntington Study Group
- Brief Summary
The Huntington Study Group currently holds the registered trademark for the Unified Huntington's Disease Rating Scale. The UHDRS® is a research tool which has been developed by the HSG to provide a uniform assessment of the clinical features and course of HD. The UHDRS® has undergone extensive reliability and validity testing and has been used as a major outcome measure by the HSG in controlled clinical trials.
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)
- Detailed Description
The UHDRS® is comprised of five components:
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- Are male or female and 18 years or older at the time of signing the informed consent
- Are able and willing to provide written informed consent
- Are English speaking
- Currently exhibit motor signs and symptoms of Huntington Disease
- 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
- Have oral and written communication skills that are sufficient/adequate to complete all cognitive assessments
- Are ambulatory, but may use any assistive device or require help
- Are able to maintain stable medications for 30 days prior to Screening/Baseline through the second in-person visit
- Have a study partner available to help with technology and set-up and to attend all study visits
- Have the ability to get email on the device used for the study
- Are unable to complete cognitive or functional assessments due to inability to communicate
- 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
- Have inadequate space at home to assess 10 steps for gait assessments
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Unified Huntington's Disease Rating Scale from the TeleVisit to the second In-Person Visit, up to 6 weeks Total Functional Capacity:
Minimum Score = 0 Maximum Score = 13 Greater scores indicate higher functioningUnited Huntington's Disease Rating Scale from TeleVisit to the second In-Person Visit, up to 6 weeks Functional Assessment Minimum Score = 0 Maximum Score = 25 Higher scores indicate greater functionality
- Secondary Outcome Measures
Name Time Method virtual Unified Huntington's Disease Rating Scale from first In-Person visit through Follow-Up, up to 6 weeks Feasibility of completing the vUHDRS™ using participant personal equipment vs. Huntington Study Group provided equipment.
Unified Huntington's Disease Rating Scale from the TeleVisit to the second In-Person Visit, up to 6 weeks Behavior minimum = 0, maximum = 88 Higher scores indicate more behavioral symptoms
Safety of conducting the UHDRS remotely from initial informed consent and continue until 30 days following the Participant's completion of the study Reported adverse events
Trial Locations
- Locations (17)
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Indiana University School of Medicine
🇺🇸Indianapolis, Indiana, United States
Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
University of Vermont Medical Center
🇺🇸Burlington, Vermont, United States
University of Texas, Health Science Center
🇺🇸Houston, Texas, United States
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 South Florida, Huntington Disease Center of Excellence
🇺🇸Tampa, Florida, United States
University of California, San Diego
🇺🇸La Jolla, California, United States
Hereditary Neurological Disease Center
🇺🇸Wichita, Kansas, United States
Northwestern University Medical Center, Department of Neurology
🇺🇸Chicago, Illinois, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
Massachusetts General Hospital
🇺🇸Charlestown, Massachusetts, United States
Sanford Brain and Spine Clinic
🇺🇸Fargo, North Dakota, United States
Georgetown University
🇺🇸Washington, District of Columbia, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States