Recruiting

tDCS

Sponsor:

The University of Texas Health Science Center at San Antonio

Code:

NCT06843252

Conditions

Huntington Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Transcranial direct current stimulation (tDCS)

Sham tDCS

Study Details

Brief 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 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.

Conditions

Huntington Disease

Study ID

NCT06843252

Start date

Sep 2, 2025

Status verified date

Feb, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. individuals aged 18-85 years with confirmed HD mutation and/or established family history alongside typical symptoms (i.e., chorea) of HD;
2. 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);
3. 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;
4. stable doses of medications for at least one month.
5. Ability of subject to understand and the willingness to sign a written informed consent document.
6. Have a caregiver willing to be present during tDCS sessions and answer questionnaires.

Caregiver

1. An adult who serves as an unpaid caregiver for an individual enrolled in the study as interpreted by the PI or delegate physician.
2. Adequate cognitive capacity to provide verbal consent to participate in the caregiver arm of the study.
3. 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.

Exclusion Criteria:

1. Unstable medical conditions (e.g. unstable angina, uncontrolled diabetes and hypertension, advanced cancer, etc.);
2. History of epilepsy;
3. Clinical diagnosis of major cognitive disorder (i.e., dementia);
4. 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);
5. Being an active participant in other therapeutic clinical trial;
6. Determined to be incapable of consent per PMH or via assessment by the study staff at time of consent.
7. 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

Study Design

Enrollment

16 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Active TDCS treatment

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 comparator: Sham TDCS treatment

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.

Interventions

Transcranial direct current stimulation (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 tDCS

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.

Primary outcome measure

  • Percentage of Participants that met Inclusion Criteria [ Time Frame: Baseline ]
  • Percentage of Participants that Agreed to Randomization [ Time Frame: Baseline ]
  • Completed period 1 of study [ Time Frame: Day 13 ]
  • Completed period 2 of study [ Time Frame: Day 35 ]
  • Completion of study to last visit [ Time Frame: Day 36 (or day 37) ]
  • TDCS Acceptability Scale [ Time Frame: Day 14 and Day 35 ]
  • tDCS Side Effects Scale [ Time Frame: Day 8, 14, 29 and 35 ]

Central Contacts and Locations

Central contacts

Thiago Macedo e Cordeiro, MD, MSc

210-450-7055macedoecorde@uthscsa.edu

Antonio L Teixeira, MD, PhD

210-450-8636teixeiraa@uthscsa.edu

Locations

University of Texas Health Science Center at San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Thiago Macedo e Cordeiro, MD, MSc

210-450-8418macedoecorde@uthscsa.edu

Antonio L Teixeira, MD, PhD

210-450-8636teixeiraa@uthscsa.edu

More Information

Sponsor

The University of Texas Health Science Center at San Antonio

Last update posted

Feb 11, 2026

Last verified

Feb, 2026

Keywords

  • Transcranial direct current stimulation
  • Home-based
  • Behavioral symptoms
  • Cognitive symptoms

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center at San Antonio on 2026-02-11.