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vUHDRS: Development of the Virtual Unified Huntington's Disease Rating Scale

Sponsor
Huntington Study Group (Other)
Overall Status
Recruiting
CT.gov ID
NCT05748288
Collaborator
(none)
60
Enrollment
17
Locations
14.3
Anticipated Duration (Months)
3.5
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Development of the Virtual Unified Huntington's Disease Rating Scale
    Actual Study Start Date :
    Sep 22, 2022
    Anticipated Primary Completion Date :
    Sep 1, 2023
    Anticipated Study Completion Date :
    Dec 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Personal Equipment

    Participants assigned to use technology they currently own
    HSG Equipment

    Participants provided technology by the sponsor

    Outcome Measures

    Primary Outcome Measures

    1. Unified Huntington's Disease Rating Scale [from the TeleVisit to the second In-Person Visit, up to 6 weeks]

      Total Motor Score: Minimum Score = 0 Maximum Score = 124 Higher scores indicate more impaired motor functioning

    2. 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 functioning

    3. United Huntington's Disease Rating Scale [from the TeleVisit to the second In-Person Visit, up to 6 weeks]

      Independence Scale Minimum Score = 0 Maximum Score = 100 Greater scores indicate greater independence

    4. United 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

    1. 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

    2. Unified Huntington's Disease Rating Scale [from the TeleVisit to the second In-Person Visit, up to 6 weeks]

      Cognitive Function: Verbal Fluency minimum = 0, maximum is based upon participant responses Symbol Digit Modality (SDMT) minimum = 0, maximum = 110 Stroop minimum = 0, maximum is based upon participant responses Higher scores indicate greater cognitive function

    3. Unified Huntington's Disease Rating Scale [Week 2, and Week 0 or Week 4]

      Total Motor Score Minimum Score = 0 Maximum Score = 124 Higher scores indicate more impaired motor functioning

    4. 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.

    5. 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

    Other Outcome Measures

    1. Participant Satisfaction [from first In-Person visit through Follow-Up, up to 6 weeks]

      Survey

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Are male or female and 18 years or older at the time of signing the informed consent

    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

    1. in the huntingtin (HTT) gene at or before Screening/Baseline visit from a validated laboratory

    1. Have oral and written communication skills that are sufficient/adequate to complete all cognitive assessments

    2. Are ambulatory, but may use any assistive device or require help

    3. Are able to maintain stable medications for 30 days prior to Screening/Baseline through the second in-person visit

    4. Have a study partner available to help with technology and set-up and to attend all study visits

    5. Have the ability to get email on the device used for the study

    Exclusion Criteria:

    1. Are unable to complete cognitive or functional assessments due to inability to communicate

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham, Department of Neurology Birmingham Alabama United States 35233
    2 University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205
    3 University of California, San Diego La Jolla California United States 93037
    4 Georgetown University Washington District of Columbia United States 20007
    5 University of South Florida, Huntington Disease Center of Excellence Tampa Florida United States 33612
    6 Northwestern University Medical Center, Department of Neurology Chicago Illinois United States 60611
    7 Rush University Medical Center Chicago Illinois United States 60612
    8 Indiana University School of Medicine Indianapolis Indiana United States 46202
    9 Hereditary Neurological Disease Center Wichita Kansas United States 67226
    10 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
    11 Massachusetts General Hospital Charlestown Massachusetts United States 02129
    12 Washington University Saint Louis Missouri United States 63110
    13 Sanford Brain and Spine Clinic Fargo North Dakota United States 58103
    14 Ohio State University Medical Center Columbus Ohio United States 43210
    15 University of Pittsburgh Pittsburgh Pennsylvania United States 15213
    16 University of Texas, Health Science Center Houston Texas United States 77030
    17 University of Vermont Medical Center Burlington Vermont United States 05401

    Sponsors and Collaborators

    • Huntington Study Group

    Investigators

    • Principal Investigator: Samuel Frank, MD, Huntington Study Group
    • Study Director: Jody Goldstein, Huntington Study Group

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Huntington Study Group
    ClinicalTrials.gov Identifier:
    NCT05748288
    Other Study ID Numbers:
    • vUHDRS
    First Posted:
    Feb 28, 2023
    Last Update Posted:
    Feb 28, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Huntington Disease

    Study Results

    No Results Posted as of Feb 28, 2023