Home-based TDCS (Transcranial Direct Current Stimulation) for Cognitive and Behavioral Symptoms in Huntington's Disease

NCT ID: NCT06843252

Last Updated: 2026-02-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-02
• Study Completion Date: 2027-06-30

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Transcranial direct current stimulation (tDCS)

Intervention Type: DEVICE

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 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.

Group Type: SHAM_COMPARATOR

Sham tDCS

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Other Intervention Names

tDCS; Control

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Huntington's Disease Society of America

OTHER

Sponsor Role: collaborator

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thiago Macedo e Cordeiro, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center at San Antonio

Locations

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Thiago Macedo e Cordeiro, MD, MSc

Role: CONTACT

macedoecorde@uthscsa.edu

210-450-7055

Antonio L Teixeira, MD, PhD

Role: CONTACT

teixeiraa@uthscsa.edu

210-450-8636

Facility Contacts

Thiago Macedo e Cordeiro, MD, MSc

Role: primary

macedoecorde@uthscsa.edu

210-450-8418

Antonio L Teixeira, MD, PhD

Role: backup

teixeiraa@uthscsa.edu

210-450-8636

Other Identifiers

STUDY00000882

Identifier Type: -

Identifier Source: org_study_id