Development of the Virtual Unified Huntington's Disease Rating Scale

NCT05748288 | Completed

• 1 other identifier: vUHDRS
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 17

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)

Conditions

Huntington Disease

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (5)

• Safety of conducting the UHDRS remotely

  from initial informed consent and continue until 30 days following the Participant's completion of the study

• Unified Huntington's Disease Rating Scale

  from the TeleVisit to the second In-Person Visit, up to 6 weeks

• Unified Huntington's Disease Rating Scale

  Week 2, and Week 0 or Week 4

• virtual Unified Huntington's Disease Rating Scale

  from first In-Person visit through Follow-Up, up to 6 weeks

• Unified Huntington's Disease Rating Scale

  from the TeleVisit to the second In-Person Visit, up to 6 weeks

Other Outcomes (1)

• Participant Satisfaction

  from first In-Person visit through Follow-Up, up to 6 weeks

Study Arms (2)

Personal Equipment

Participants assigned to use technology they currently own

HSG Equipment

Participants provided technology by the sponsor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be enrolled from clinics with physicians who are members of the Huntington Study Group

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.

Sponsors & Collaborators

• Huntington Study Group: lead

Study Sites (17)

University of Alabama at Birmingham, Department of Neurology

Birmingham, Alabama, 35233, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

University of California, San Diego

La Jolla, California, 93037, United States

Location

Georgetown University

Washington D.C., District of Columbia, 20007, United States

Location

University of South Florida, Huntington Disease Center of Excellence

Tampa, Florida, 33612, United States

Location

Northwestern University Medical Center, Department of Neurology

Chicago, Illinois, 60611, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

Hereditary Neurological Disease Center

Wichita, Kansas, 67226, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Massachusetts General Hospital

Charlestown, Massachusetts, 02129, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Sanford Brain and Spine Clinic

Fargo, North Dakota, 58103, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Texas, Health Science Center

Houston, Texas, 77030, United States

Location

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Location

MeSH Terms

Conditions

Huntington Disease

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Chorea; Dyskinesias; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Samuel Frank, MD

  Huntington Study Group

  PRINCIPAL INVESTIGATOR

• Jody Goldstein

  Huntington Study Group

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: February 28, 2023
• Study Start: September 22, 2022
• Primary Completion: May 2, 2023
• Study Completion: May 2, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

US (17)