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

NCT06843252 | Recruiting FDA Device

• 1 other identifier: STUDY00000882
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (7)

• Percentage of Participants that met Inclusion Criteria

  Percentage of participants screened that met Inclusion Criteria

  Baseline

• Percentage of Participants that Agreed to Randomization

  Percentage of eligible participants that were screened and met eligibility that agreed to be randomized.

  Baseline

• Completed period 1 of study

  Percentage of participants who completed first 2 weeks of treatment or sham

  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

  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

  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.

  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.

  Day 8, 14, 29 and 35

Secondary Outcomes (2)

• Problem Behaviors Assessment Scale (PBA-S)

  Baseline, and days 14, 22, and 35.

• Frontal Assessment Battery (FAB)

  Baseline, and days 14 and 35.

Study Arms (2)

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.

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.

Device: Sham tDCS

Interventions

Transcranial direct current stimulation (tDCS) 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.

Also known as: tDCS

Active TDCS treatment

Sham tDCS 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.

Also known as: Control

Sham TDCS treatment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• Participant has a pacemaker or any other implanted device/material contraindicated in the use of tDCS per current labeling requirements.
• Caregiver

Sponsors & Collaborators

• Huntington's Disease Society of America: collaborator
• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

MeSH Terms

Conditions

Huntington Disease; Behavioral Symptoms; Neurobehavioral Manifestations

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Chorea; Dyskinesias; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Thiago Macedo e Cordeiro, MD, MSc

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thiago Macedo e Cordeiro, MD, MSc

CONTACT

210-450-7055; macedoecorde@uthscsa.edu

Antonio L Teixeira, MD, PhD

CONTACT

210-450-8636; teixeiraa@uthscsa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Patients will be blinded throughout the trial. As the application of tDCS electrical current over the skin can be perceived by the participants, the study team will employ a sham condition that has been shown to be reliable and indistinguishable from active treatment in previous clinical trials published in the available scientific literature. An individual on the study team will be delegated to randomize and program and re-program devices. Participants will act as their own control. The researcher supervising the stimulation will be blinded to the intervention the participant is receiving.
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: February 24, 2025
• Study Start: September 2, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: When the study is completed and data is analyzed.

Locations

US (1)