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Completed

NCT Number: NCT05748288

Development of the Virtual Unified Huntington's Disease Rating Scale

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)

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alabama at Birmingham, Department of Neurology, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Unified Huntington's Disease Rating Scale

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. Safety of conducting the UHDRS remotely

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. Participant Satisfaction

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

    Survey

Sponsors and collaborators

Lead sponsor

Huntington Study Group

Network

Registry information

Acronym: vUHDRS

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 28, 2023
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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