Huntington DiseasevUHDRSNCT05748288
Development of the Virtual Unified Huntington's Disease Rating Scale
An observational study of Huntington Disease, run by Huntington Study Group at 17 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Huntington Disease
- How many people
- 60 participants
- Where
- 17 sitesUnited States
- Study dates
- 22 Sep 2022to 2 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be enrolled from clinics with physicians who are members of the Huntington Study Group
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
University of Alabama at Birmingham, Department of Neurology
Birmingham, Alabama, 35233
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
University of Vermont Medical Center
Burlington, Vermont, 05401
Massachusetts General Hospital
Charlestown, Massachusetts, 02129
Northwestern University Medical Center, Department of Neurology
Chicago, Illinois, 60611
Rush University Medical Center
Chicago, Illinois, 60612
Ohio State University Medical Center
Columbus, Ohio, 43210
Sanford Brain and Spine Clinic
Fargo, North Dakota, 58103
University of Texas, Health Science Center
Houston, Texas, 77030
Indiana University School of Medicine
Indianapolis, Indiana, 46202
University of California, San Diego
La Jolla, California, 93037
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Washington University
St Louis, Missouri, 63110
University of South Florida, Huntington Disease Center of Excellence
Tampa, Florida, 33612
Georgetown University
Washington D.C., District of Columbia, 20007
Hereditary Neurological Disease Center
Wichita, Kansas, 67226
About this study
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)
Read the 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.
- Conditions
- Huntington Disease
- Medical subject headings
- Huntington Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Personal Equipment | Participants assigned to use technology they currently own | |
| HSG Equipment | Participants provided technology by the sponsor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unified Huntington's Disease Rating Scale
Total Motor Score:
Minimum Score = 0 Maximum Score = 124 Higher scores indicate more impaired motor functioning
Measured: 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
Measured: 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
Measured: 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
Measured: from TeleVisit to the second In-Person Visit, up to 6 weeks
Secondary outcomes (5)
Safety of conducting the UHDRS remotely
Reported adverse events
Measured: from initial informed consent and continue until 30 days following the Participant's completion of the study
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
Measured: from the TeleVisit to the second In-Person Visit, up to 6 weeks
Unified Huntington's Disease Rating Scale
Total Motor Score Minimum Score = 0 Maximum Score = 124 Higher scores indicate more impaired motor functioning
Measured: Week 2, and Week 0 or Week 4
virtual Unified Huntington's Disease Rating Scale
Feasibility of completing the vUHDRS™ using participant personal equipment vs. Huntington Study Group provided equipment.
Measured: from first In-Person visit through Follow-Up, up to 6 weeks
Unified Huntington's Disease Rating Scale
Behavior minimum = 0, maximum = 88 Higher scores indicate more behavioral symptoms
Measured: from the TeleVisit to the second In-Person Visit, up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start22 Sep 2022
- Primary completion2 May 2023
- Study completion2 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Huntington DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huntington Study Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Samuel Frank, MD, Principal investigator, Huntington Study GroupJody Goldstein, Study director, Huntington Study Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05748288
- Sponsor's protocol ID
- vUHDRS
- Acronym
- vUHDRS
- Status last verified
- Sep 2023
- First submitted
- 20 Oct 2022
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of the Virtual Unified Huntington's Disease Rating Scale
- ClinicalTrials.gov ID
- NCT05748288
- Acronym / sponsor ID
- vUHDRS / vUHDRS
- Conditions
- Huntington Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Huntington Study GroupResearch network
- Study start
- 22 Sep 2022 (actual)
- Primary completion
- 2 May 2023 (actual)
- Study completion
- 2 May 2023 (actual)
- First posted
- 28 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personal Equipment | – | –Participants assigned to use technology they currently own |
| HSG Equipment | – | –Participants provided technology by the sponsor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be enrolled from clinics with physicians who are members of the Huntington Study Group
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
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
5 secondary outcomes
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
Unified Huntington's Disease Rating Scale
Time frame: from the TeleVisit to the second In-Person Visit, up to 6 weeks
Unified Huntington's Disease Rating Scale
Time frame: Week 2, and Week 0 or Week 4
virtual Unified Huntington's Disease Rating Scale
Time frame: from first In-Person visit through Follow-Up, up to 6 weeks
Unified Huntington's Disease Rating Scale
Time frame: from the TeleVisit to the second In-Person Visit, up to 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel Frank, MD principal investigator
Huntington Study Group
Jody Goldstein study director
Huntington Study Group
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Huntington Disease, run by Huntington Study Group at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unified Huntington's Disease Rating Scale (time frame: from the TeleVisit to the second In-Person Visit, up to 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.