Huntington DiseaseNCT06843252
Home-based TDCS (Transcranial Direct Current Stimulation) for Cognitive and Behavioral Symptoms in Huntington's Disease
A study testing Transcranial direct current stimulation (tDCS) in people with Huntington Disease, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
The researchers hope to find out effects of transcranial direct current stimulation (tDCS) sessions on the behavioral symptoms of Huntington's Disease. If participants are eligible to continue, they will be provided a device to administer the tDCS for 30 minutes each day and be asked to answer questions with the study… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Huntington Disease
- What is being tested?
- Transcranial direct current stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2025to Jun 2027
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- individuals aged 18-85 years with confirmed HD mutation 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 criteria, also known as the UHDRS total functional capacity (TFC) scale (Bates, Tabrizi, and Jones 2014);
- 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.
- Ability of subject to understand and the willingness to sign a written informed consent document.
- Have a caregiver willing to be present during tDCS sessions and answer questionnaires.
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- Caregiver
- An adult who serves as an unpaid caregiver for an individual enrolled in the study as interpreted by the PI or delegate physician.
- Adequate cognitive capacity to provide verbal consent to participate in the caregiver arm of the study.
- Adequate reading, writing, hearing, and verbal capacity to provide collateral information about the study participant as well as answer questions related to their health and care.
Who cannot join
- Unstable medical conditions (e.g. unstable angina, uncontrolled diabetes and hypertension, advanced cancer, etc.);
- History of epilepsy;
- Clinical diagnosis of major cognitive disorder (i.e., dementia);
- Have risk of suicidal behavior, defined as any suicidal behavior or suicidal ideation of type 4 (active suicidal ideation with some intent to act, without specific plan) or type 5 (active suicidal ideation with specific plan and intent) based on the Columbia-Suicide Severity Rating Scale (C-SSRS) in the 3 months prior to screening (Posner et al. 2011);
- Being an active participant in other therapeutic clinical trial;
- Determined to be incapable of consent per PMH or via assessment by the study staff at time of consent.
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- Participant has a pacemaker or any other implanted device/material contraindicated in the use of tDCS per current labeling requirements.
- Caregiver
- 1. Any individual who does not meet all the inclusion criteria
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
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Thiago Macedo e Cordeiro, MD, MSc, 210-450-8418, macedoecorde@uthscsa.edu
Antonio L Teixeira, MD, PhD, 210-450-8636, teixeiraa@uthscsa.edu
About this study
Official title: Home-based TDCS for Cognitive and Behavioral Symptoms in Huntington's Disease: a Pilot Feasibility and Mechanistic Study
The researchers hope to find out effects of transcranial direct current stimulation (tDCS) sessions on the behavioral symptoms of Huntington's Disease. If participants are eligible to continue, they will be provided a device to administer the tDCS for 30 minutes each day and be asked to answer questions with the study staff . Participants will be asked to return to the study center for follow ups and to undergo additional cognitive tests and questionnaires. Participants will also be asked to answer questionnaires via a web conferencing platform (Zoom) during the course of the study. Caregivers of the participants will be asked to answer questionnaires to collect more information about the participants.
Read the detailed description
This clinical trial will investigate the effects of transcranial direct current stimulation (tDCS) over cognitive and behavioral symptoms of patients with Huntington's disease (HD). The study will also investigate underlying neurobiological mechanisms of tDCS in HD.
- Conditions
- Huntington Disease
- Being tested
- Transcranial direct current stimulation (tDCS), Sham tDCS
- Keywords
- Transcranial direct current stimulation, Home-based, Behavioral symptoms, Cognitive symptoms
- Medical subject headings
- Huntington Disease, Behavioral Symptoms, Neurobehavioral Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulation (tDCS)Device
Also called tDCS
The active-tDCS treatment will consist of a constant 2mA current applied during daily 30-minute sessions with a 30 second ramp up and ramp down at the start and end of the stimulation. The anode electrode will be placed over the left dorsolateral prefrontal cortex (DLPFC) and the cathode electrode over the right DLPFC.
Sham tDCSDevice
Also called Control
Sham-tDCS treatment will consist of the same montage as the active TDCS with the built-in function of the device that has been shown to be indistinguishable from the active treatment in previous trials described in the literature.
| Study group | Role | What they receive |
|---|---|---|
| Active TDCS treatment | Experimental | The active-tDCS treatment will consist of a constant 2mA current applied during 30-minute sessions with a 30 second ramp up and ramp down at the start and end of the stimulation. Receives: Device: Transcranial direct current stimulation (tDCS) |
| Sham TDCS treatment | Sham comparator | Sham-tDCS treatment will consist of the same montage as the active TDCS with the built-in function of the device that has been shown to be indistinguishable from the active treatment in previous trials described in the literature. Receives: Device: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants that met Inclusion Criteria
Percentage of participants screened that met Inclusion Criteria
Measured: Baseline
Percentage of Participants that Agreed to Randomization
Percentage of eligible participants that were screened and met eligibility that agreed to be randomized.
Measured: Baseline
Completed period 1 of study
Percentage of participants who completed first 2 weeks of treatment or sham
Measured: Day 13
Completed period 2 of study
Percentage of participants that completed both the first period, the washout period and the second period of the study
Measured: Day 35
Completion of study to last visit
Percentage of participants that completed study from randomization to tDCS/Sham crossed over to alternate treatment/sham and returned for final visit
Measured: Day 36 (or day 37)
TDCS Acceptability Scale
This Likert scale scores 10 items for user acceptability. Each item is scored from 0-10 giving. Some items have negative valence, in which lower scores indicate higher acceptability. An averaged of adjusted scores for all items is calculated to produce a global acceptability score ranging from 0 to 10. A higher score on the global score indicates better acceptability.
Measured: Day 14 and Day 35
tDCS Side Effects Scale
This Likert scale includes 10 items scored from 0-10 for possible side effects. The first 9 items include a list of possible side effects and the last item is free field for the report of any additional side effects. Lower scores indicate less intensity of side effects. Scores will be reported for each individual item.
Measured: Day 8, 14, 29 and 35
Secondary outcomes (2)
Problem Behaviors Assessment Scale (PBA-S)
This scale rates the participant's average behavior over the past weeks by taking into account the severity and frequency of a range of psychiatric symptoms. There are 11 items assessed with a possible total score range of 0-176. A lower score indicates less psychiatric symptoms.
Measured: Baseline, and days 14, 22, and 35.
Frontal Assessment Battery (FAB)
This scale is a brief cognitive and behavioral battery. The total maximum score is 18, with higher scores indicating better performance.
Measured: Baseline, and days 14 and 35.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start2 Sep 2025
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a randomized double-blind cross-over clinical trial. Participants will be their own control and in addition, caregivers will provide collateral information regarding the participant via structured interviews or questionnaires.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Sponsor type
- University, hospital or other
- Collaborators
- Huntington's Disease Society of America
- Responsible party
- Sponsor
- Investigators
- Thiago Macedo e Cordeiro, MD, MSc, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06843252
- Sponsor's protocol ID
- STUDY00000882
- Status last verified
- Feb 2026
- First submitted
- 24 Jan 2025
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Data collected for this study will be analyzed and stored at the Glenn Bigs Institute for Alzheimer's and Neurodegenerative diseases at UT Health San Antonio. After the study is completed, the de-identified, archived data will be transmitted to and stored at the Glenn Bigs Institute for Alzheimer's and Neurodegenerative diseases at UT Health San Antonio, for use by other researchers including those outside of the study. Permission to transmit data to the Glenn Biggs Institute for Alzheimer's and Neurodegenerative diseases at UT Health San Antonio will be included in the informed consent.
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 TDCS for Cognitive and Behavioral Symptoms in Huntington's Disease: a Pilot Feasibility and Mechanistic Study
- ClinicalTrials.gov ID
- NCT06843252
- Acronym / sponsor ID
- STUDY00000882
- Conditions
- Huntington Disease
- Keywords
- Transcranial direct current stimulation, Home-based, Behavioral symptoms, Cognitive symptoms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- Huntington's Disease Society of America
- Study start
- 2 Sep 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 24 Feb 2025 (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 researchers hope to find out effects of transcranial direct current stimulation (tDCS) sessions on the behavioral symptoms of Huntington's Disease. If participants are eligible to continue, they will be provided a device to administer the tDCS for 30 minutes each day and be asked to answer questions with the study staff . Participants will be asked to return to the study center for follow ups and to undergo additional cognitive tests and questionnaires. Participants will also be asked to answer questionnaires via a web conferencing platform (Zoom) during the course of the study. Caregivers of the participants will be asked to answer questionnaires to collect more information about the participants.
Detailed description
This clinical trial will investigate the effects of transcranial direct current stimulation (tDCS) over cognitive and behavioral symptoms of patients with Huntington's disease (HD). The study will also investigate underlying neurobiological mechanisms of tDCS in HD.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a randomized double-blind cross-over clinical trial. Participants will be their own control and in addition, caregivers will provide collateral information regarding the participant via structured interviews or questionnaires.
| Arm | Type | Receives |
|---|---|---|
| Active TDCS treatment | Experimental | Device: Transcranial direct current stimulation (tDCS)The active-tDCS treatment will consist of a constant 2mA current applied during 30-minute sessions with a 30 second ramp up and ramp down at the start and end of the stimulation. |
| Sham TDCS treatment | Sham comparator | Device: Sham tDCSSham-tDCS treatment will consist of the same montage as the active TDCS with the built-in function of the device that has been shown to be indistinguishable from the active treatment in previous trials described in the literature. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- individuals aged 18-85 years with confirmed HD mutation 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 criteria, also known as the UHDRS total functional capacity (TFC) scale (Bates, Tabrizi, and Jones 2014);
- 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.
- Ability of subject to understand and the willingness to sign a written informed consent document.
Key exclusion criteria (9 listed)
- Unstable medical conditions (e.g. unstable angina, uncontrolled diabetes and hypertension, advanced cancer, etc.);
- History of epilepsy;
- Clinical diagnosis of major cognitive disorder (i.e., dementia);
- Have risk of suicidal behavior, defined as any suicidal behavior or suicidal ideation of type 4 (active suicidal ideation with some intent to act, without specific plan) or type 5 (active suicidal ideation with specific plan and intent) based on the Columbia-Suicide Severity Rating Scale (C-SSRS) in the 3 months prior to screening (Posner et al. 2011);
- Being an active participant in other therapeutic clinical trial;
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 |
|---|---|---|
| Transcranial direct current stimulation (tDCS)Also: tDCSThe active-tDCS treatment will consist of a constant 2mA current applied during daily 30-minute sessions with a 30 second ramp up and ramp down at the start and end of the stimulation. The anode electrode will be placed over the left dorsolateral prefrontal cortex (DLPFC) and the cathode electrode over the right DLPFC. | Device | Active TDCS treatment |
| Sham tDCSAlso: ControlSham-tDCS treatment will consist of the same montage as the active TDCS with the built-in function of the device that has been shown to be indistinguishable from the active treatment in previous trials described in the literature. | Device | Sham TDCS treatment |
Primary outcome
Percentage of Participants that met Inclusion Criteria
Time frame: Baseline
Percentage of participants screened that met Inclusion Criteria
Percentage of Participants that Agreed to Randomization
Time frame: Baseline
Percentage of eligible participants that were screened and met eligibility that agreed to be randomized.
Completed period 1 of study
Time frame: Day 13
Percentage of participants who completed first 2 weeks of treatment or sham
Completed period 2 of study
Time frame: Day 35
Percentage of participants that completed both the first period, the washout period and the second period of the study
Completion of study to last visit
Time frame: Day 36 (or day 37)
Percentage of participants that completed study from randomization to tDCS/Sham crossed over to alternate treatment/sham and returned for final visit
TDCS Acceptability Scale
Time frame: Day 14 and Day 35
This Likert scale scores 10 items for user acceptability. Each item is scored from 0-10 giving. Some items have negative valence, in which lower scores indicate higher acceptability. An averaged of adjusted scores for all items is calculated to produce a global acceptability score ranging from 0 to 10. A higher score on the global score indicates better acceptability.
tDCS Side Effects Scale
Time frame: Day 8, 14, 29 and 35
This Likert scale includes 10 items scored from 0-10 for possible side effects. The first 9 items include a list of possible side effects and the last item is free field for the report of any additional side effects. Lower scores indicate less intensity of side effects. Scores will be reported for each individual item.
2 secondary outcomes
Problem Behaviors Assessment Scale (PBA-S)
Time frame: Baseline, and days 14, 22, and 35.
Frontal Assessment Battery (FAB)
Time frame: Baseline, and days 14 and 35.
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: Yes. Data collected for this study will be analyzed and stored at the Glenn Bigs Institute for Alzheimer's and Neurodegenerative diseases at UT Health San Antonio. After the study is completed, the de-identified, archived data will be transmitted to and stored at the Glenn Bigs Institute for Alzheimer's and Neurodegenerative diseases at UT Health San Antonio, for use by other researchers including those outside of the study. Permission to transmit data to the Glenn Biggs Institute for Alzheimer's and Neurodegenerative diseases at UT Health San Antonio will be included in the informed consent.
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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.
Thiago Macedo e Cordeiro, MD, MSc principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial direct current stimulation (tDCS) in people with Huntington Disease, run by The University of Texas Health Science Center at San Antonio 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 10 inclusion and 9 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. Some participants in this study may receive a placebo. 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 Thiago Macedo e Cordeiro, MD, MSc (210-450-7055, macedoecorde@uthscsa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants that met Inclusion Criteria (time frame: Baseline). The study lists 7 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.