Development of the Virtual Unified Huntington's Disease Rating Scale
a study on Huntington's Disease
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at La Jolla, California and other locations
- Dates
- study startedestimated completion
Description
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)
Details
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.
Keywords
Huntington Disease, Personal Equipment, HSG Equipment
Eligibility
You can join if…
Open to people ages 18 years and up
- 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
10. Have the ability to get email on the device used for the study
You CAN'T join if...
- 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.
Locations
- University of California, San Diego
accepting new patients
La Jolla California 93037 United States - Hereditary Neurological Disease Center
accepting new patients
Wichita Kansas 67226 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Huntington Study Group
- ID
- NCT05748288
- Study Type
- Observational
- Participants
- Expecting 60 study participants
- Last Updated
Please contact me about this study
We will not share your information with anyone other than the team in charge of this study. Submitting your contact information does not obligate you to participate in research.
Thank you!
The study team should get back to you in a few business days.