Huntington DiseaseNCT05326451
Home-based Transcranial Direct Current Stimulation Open Trial for Behavioral and Cognitive Symptoms in Huntington's Disease
A study testing active tDCS in people with Huntington Disease, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to assess feasibility, acceptability, and safety of providing transcranial direct current stimulation( tDCS) to Huntingtons Disease (HD) patients in the early to middle stages and to assess the efficacy of tDCS for HD-related behavioral, cognitive and other symptoms Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Huntington Disease
- What is being tested?
- active tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- confirmed HD mutation carriers and/or established family history alongside typical symptoms (i.e. chorea) of HD;
- early (stages 1 and 2) or moderate (stage 3) stages according to Shoulson-Fahn
- exhibit mild to moderate behavioral symptoms defined by severity scores in the PBA-S between 1 and 3 for any of the evaluated symptoms and no symptoms with a severity score of 4
- stable doses of medications for at least one month
- Have a caregiver willing to be present during tDCS sessions and answer questionnaires.
- -willingness to participate in the study
Who cannot join
- unstable medical conditions
- history of epilepsy
- metallic objects in the brain
- Have a caregiver willing to be present during tDCS sessions and answer questionnaires.
- clinical diagnosis of major cognitive disorder or dementia
- Have risk of suicidal behavior, defined as any suicidal behavior or suicidal ideation of type 4 or type 5 based on the Columbia-Suicide Severity Rating Scale (C-SSRS) in the 3 months prior to screening
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- simultaneous participation in other clinical trial
- Individuals determined to be incapable of consent per past medical history or via assessment by the study staff at time of consent.
- Caregiver:
- -motor/cognitive symptoms related to Alzheimer's disease or Huntington's disease that might impair the ability to assist the participant during the research study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Erin Stimming, MD, (713) 500-7033, Erin.E.Furr@uth.tmc.edu
Thiago Macedo e Cordeiro, MD, 210-450-7055, macedoecorde@uthscsa.edu
About this study
The purpose of this study is to assess feasibility, acceptability, and safety of providing transcranial direct current stimulation( tDCS) to Huntingtons Disease (HD) patients in the early to middle stages and to assess the efficacy of tDCS for HD-related behavioral, cognitive and other symptoms
- Conditions
- Huntington Disease
- Being tested
- active tDCS
- Keywords
- transcranial direct current stimulation
- Medical subject headings
- Huntington Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active tDCSDevice
Participants will receive active tDCS with a constant current intensity of 2mA. Anodal tDCS will be applied to the left dorsolateral prefrontal cortex, while cathodal electrode will be positioned on the right dorsolateral prefrontal cortex. Caregivers will help setting up and administering tDCS for participants with HD at home. tDCS will be applied for 30min at an intensity of 2mA, with 30 s ramping up and down. Sessions will be remotely supervised by trained research staff (RA), and will run from Monday through Friday for four consecutive weeks.
| Study group | Role | What they receive |
|---|---|---|
| active tDCS | Experimental | Not described Receives: Device: active tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility as assessed by the number of participants included and who successfully completed the protocol
Measured: through study completion, an average of 8 weeks
Change in acceptability of the treatment as assessed by the tDCS acceptability questionnaire
Acceptability will be evaluated using a Likert scale (from 0 [strongly disagree] to 10 [strongly agree]) to answer ten affirmatives regarding the use of home based tDCS, with a total score range of 0-10 and a higher score indicating higher acceptability.
Measured: Baseline, week 2, week 4, week 8
Change in safety of home-based tDCS treatment as as assessed by the tDCS side effect questionnaire
Safety will be assessed with a 10-item questionnaire about side effects, including itching, burning, headache, fatigue, and dizziness. Each question is scored form 0-10, with a total score range of 0-10 and a higher score indicating more side effects.
Measured: week 2, week 4
Secondary outcomes (9)
Change in Motor function as assessed by the Unified Huntington Disease Rating Scale (UHDRS)
The motor section of the UHDRS consists of 31 items rated on a 5-point ordinal scale ranging from 0 to 4, with a score of 0 indicating no abnormalities and 4 indicating the most severe impairment. Total score range is 0 to 124, with a higher score indicating decreased inability to perform motor tasks.
Measured: Baseline,week4
Change in Cognitive function as assessed by the Unified Huntington Disease Rating Scale (UHDRS)
The cognitive function section of the UHDRS consists of 5 items rated on a 5-point ordinal scale ranging from 0- to 4, with a total score range of 0 to 20 and with a higher score indicating better cognitive performance.
Measured: Baseline,week4
Change in Behavior as assessed by the Unified Huntington Disease Rating Scale (UHDRS)
The behavioral section of the UHDRS consists of 11 items evaluating various behavioral signs and symptoms. Individuals are ranked on both severity and frequency on a 0 to 4 scale, with 0 being not present and 4 being severe and frequent. Total behavioral scores are calculated by summing the severity and frequency items, with a total score range of 0 (no behavioral symptoms) to 88 (most severe behavioral symptoms).
Measured: Baseline,week4
Change in apathy as assessed by the Brief Dimensional Apathy Scale (bDAS)
This scale consists of 9 questions, each scored from 0 (almost always) to 3 (hardly ever), with a total score range of 0 to 27 and a higher score indicating more apathy.
Measured: Baseline, week 2, week 4, week 8
Change in depression as assessed by the Patient Health Questionnaire (PHQ-9)
This questionnaire has 9 questions. with each scored form 0 (not at all) to 3 (nearly every day), with a total score range of 0 to 27 and a higher score indicating more depression.
Measured: Baseline, week 2, week 4, week 8
Change in irritability as assessed by the Irritability Questionnaire
This is a 21-item questionnaire, with each item scored form 0 (never) to 3 (most of the time), for a total score range of of 0 to 63 and a higher score indicating more irritability.
Measured: Baseline, week 2, week 4, week 8
Change in cognition as assessed by the Montreal Cognitive Assessment (MoCA)
MoCA is scored from 0 to 30, with a higher score indicating better performance.
Measured: Baseline, week 2, week 4, week 8
Change in anxiety and depressive symptoms as assessed by the Hospital Anxiety and Depression Scale (HADS)
HADS is a 14-item scale, with seven items each for anxiety and depression subscales. Scoring for each item ranges from 0 to 3, with a total score range of 0 to 42 and a total subscale score range of 0 to 21. A subscale score greater than 8 denotes anxiety or depression.
Measured: Baseline, week 2, week 4, week 8
Change in behavioral symptoms as assessed by the Problem Behaviours Assessment (PBA-s)
Each symptom is rated for severity on a 5-point scale : 0 = not at all; 1 = trivial; 2 = mild; 3 = moderate (disrupting everyday activities); and 4 = severe or intolerable. Each symptom is also scored for frequency on a 5-point scale as follows: 0 = symptom absent; 1 = less than once weekly; 2 = at least once a week; 3 = most days (up to and including some part of everyday); and 4 = all day, every day. Severity and frequency scores are multiplied to produce an overall 'PBA score' for each symptom.
Measured: Baseline, 2 weeks of treatment, at the end of treatment (week 4) and 4 weeks post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start21 Jun 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erin Furr Stimming, The University of Texas Health Science Center, Houston
- Investigators
- Erin Stimming, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05326451
- Sponsor's protocol ID
- HSC-MS-21-1065
- Status last verified
- Dec 2025
- First submitted
- 5 Apr 2022
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-based Transcranial Direct Current Stimulation Open Trial for Behavioral and Cognitive Symptoms in Huntington's Disease
- ClinicalTrials.gov ID
- NCT05326451
- Acronym / sponsor ID
- HSC-MS-21-1065
- Conditions
- Huntington Disease
- Keywords
- transcranial direct current stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 21 Jun 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Apr 2022 (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 purpose of this study is to assess feasibility, acceptability, and safety of providing transcranial direct current stimulation( tDCS) to Huntingtons Disease (HD) patients in the early to middle stages and to assess the efficacy of tDCS for HD-related behavioral, cognitive and other symptoms
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| active tDCS | Experimental | Device: active tDCS |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- confirmed HD mutation carriers and/or established family history alongside typical symptoms (i.e. chorea) of HD;
- early (stages 1 and 2) or moderate (stage 3) stages according to Shoulson-Fahn
- exhibit mild to moderate behavioral symptoms defined by severity scores in the PBA-S between 1 and 3 for any of the evaluated symptoms and no symptoms with a severity score of 4
- stable doses of medications for at least one month
- Have a caregiver willing to be present during tDCS sessions and answer questionnaires.
Key exclusion criteria (10 listed)
- unstable medical conditions
- history of epilepsy
- metallic objects in the brain
- Have a caregiver willing to be present during tDCS sessions and answer questionnaires.
- clinical diagnosis of major cognitive disorder or dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| active tDCSParticipants will receive active tDCS with a constant current intensity of 2mA. Anodal tDCS will be applied to the left dorsolateral prefrontal cortex, while cathodal electrode will be positioned on the right dorsolateral prefrontal cortex. Caregivers will help setting up and administering tDCS for participants with HD at home. tDCS will be applied for 30min at an intensity of 2mA, with 30 s ramping up and down. Sessions will be remotely supervised by trained research staff (RA), and will run from Monday through Friday for four consecutive weeks. | Device | active tDCS |
Primary outcome
Feasibility as assessed by the number of participants included and who successfully completed the protocol
Time frame: through study completion, an average of 8 weeks
Change in acceptability of the treatment as assessed by the tDCS acceptability questionnaire
Time frame: Baseline, week 2, week 4, week 8
Acceptability will be evaluated using a Likert scale (from 0 [strongly disagree] to 10 [strongly agree]) to answer ten affirmatives regarding the use of home based tDCS, with a total score range of 0-10 and a higher score indicating higher acceptability.
Change in safety of home-based tDCS treatment as as assessed by the tDCS side effect questionnaire
Time frame: week 2, week 4
Safety will be assessed with a 10-item questionnaire about side effects, including itching, burning, headache, fatigue, and dizziness. Each question is scored form 0-10, with a total score range of 0-10 and a higher score indicating more side effects.
9 secondary outcomes
Change in Motor function as assessed by the Unified Huntington Disease Rating Scale (UHDRS)
Time frame: Baseline,week4
Change in Cognitive function as assessed by the Unified Huntington Disease Rating Scale (UHDRS)
Time frame: Baseline,week4
Change in Behavior as assessed by the Unified Huntington Disease Rating Scale (UHDRS)
Time frame: Baseline,week4
Change in apathy as assessed by the Brief Dimensional Apathy Scale (bDAS)
Time frame: Baseline, week 2, week 4, week 8
Change in depression as assessed by the Patient Health Questionnaire (PHQ-9)
Time frame: Baseline, week 2, week 4, week 8
Change in irritability as assessed by the Irritability Questionnaire
Time frame: Baseline, week 2, week 4, week 8
Change in cognition as assessed by the Montreal Cognitive Assessment (MoCA)
Time frame: Baseline, week 2, week 4, week 8
Change in anxiety and depressive symptoms as assessed by the Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline, week 2, week 4, week 8
Change in behavioral symptoms as assessed by the Problem Behaviours Assessment (PBA-s)
Time frame: Baseline, 2 weeks of treatment, at the end of treatment (week 4) and 4 weeks post-treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Erin Stimming, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active tDCS in people with Huntington Disease, run by The University of Texas Health Science Center, Houston at 1 site 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 6 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erin Stimming, MD ((713) 500-7033, Erin.E.Furr@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility as assessed by the number of participants included and who successfully completed the protocol (time frame: through study completion, an average of 8 weeks). The study lists 3 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 11 Feb 2026.