Development of the Virtual Unified Huntington's Disease Rating Scale

Huntington Disease Clinical Trial

— vUHDRS  

Official title:

Development of the Virtual Unified Huntington's Disease Rating Scale

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05748288
• Other study ID #: vUHDRS
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Huntington Disease

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