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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05748288
Other study ID # vUHDRS
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 22, 2022
Est. completion date May 2, 2023

Study information

Verified date September 2023
Source Huntington Study Group
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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)


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 information / eligibility

Status Completed
Enrollment 60
Est. completion date May 2, 2023
Est. primary completion date May 2, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 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: 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States University of Alabama at Birmingham, Department of Neurology Birmingham Alabama
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States University of Vermont Medical Center Burlington Vermont
United States Massachusetts General Hospital Charlestown Massachusetts
United States Northwestern University Medical Center, Department of Neurology Chicago Illinois
United States Rush University Medical Center Chicago Illinois
United States Ohio State University Medical Center Columbus Ohio
United States Sanford Brain and Spine Clinic Fargo North Dakota
United States University of Texas, Health Science Center Houston Texas
United States Indiana University School of Medicine Indianapolis Indiana
United States University of California, San Diego La Jolla California
United States University of Arkansas for Medical Sciences Little Rock Arkansas
United States University of Pittsburgh Pittsburgh Pennsylvania
United States Washington University Saint Louis Missouri
United States University of South Florida, Huntington Disease Center of Excellence Tampa Florida
United States Georgetown University Washington District of Columbia
United States Hereditary Neurological Disease Center Wichita Kansas

Sponsors (1)

Lead Sponsor Collaborator
Huntington Study Group

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Participant Satisfaction Survey from first In-Person visit through Follow-Up, up to 6 weeks
Primary Unified Huntington's Disease Rating Scale Total Motor Score:
Minimum Score = 0 Maximum Score = 124 Higher scores indicate more impaired motor functioning
from the TeleVisit to the second In-Person Visit, up to 6 weeks
Primary Unified Huntington's Disease Rating Scale Total Functional Capacity:
Minimum Score = 0 Maximum Score = 13 Greater scores indicate higher functioning
from the TeleVisit to the second In-Person Visit, up to 6 weeks
Primary United Huntington's Disease Rating Scale Independence Scale Minimum Score = 0 Maximum Score = 100 Greater scores indicate greater independence from the TeleVisit to the second In-Person Visit, up to 6 weeks
Primary United Huntington's Disease Rating Scale Functional Assessment Minimum Score = 0 Maximum Score = 25 Higher scores indicate greater functionality from TeleVisit to the second In-Person Visit, up to 6 weeks
Secondary Safety of conducting the UHDRS remotely Reported adverse events from initial informed consent and continue until 30 days following the Participant's completion of the study
Secondary Unified Huntington's Disease Rating Scale 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
from the TeleVisit to the second In-Person Visit, up to 6 weeks
Secondary Unified Huntington's Disease Rating Scale Total Motor Score Minimum Score = 0 Maximum Score = 124 Higher scores indicate more impaired motor functioning Week 2, and Week 0 or Week 4
Secondary virtual Unified Huntington's Disease Rating Scale Feasibility of completing the vUHDRS™ using participant personal equipment vs. Huntington Study Group provided equipment. from first In-Person visit through Follow-Up, up to 6 weeks
Secondary Unified Huntington's Disease Rating Scale Behavior minimum = 0, maximum = 88 Higher scores indicate more behavioral symptoms from the TeleVisit to the second In-Person Visit, up to 6 weeks
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