Development of the Virtual Unified Huntington's Disease Rating Scale

Completed

Conditions studied: Huntington Disease

In brief

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)

Key facts

Study ID

NCT05748288

Run by

Huntington Study Group

People needed

60

Starts

2022-09-22

Expected to finish

2023-05-02

Last updated by the study team

2023-09-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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