Home-based TDCS (Transcranial Direct Current Stimulation) for Cognitive and Behavioral Symptoms in Huntington's Disease
Purpose
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 more time for follow ups and to undergo additional thinking tests and questionnaires. Participants will also be asked to answer questionnaires over the phone or via a web conferencing platform (Zoom) 3 times during the course of the study. Caregivers of the participants will be asked to complete questionnaires to collect more information about the participants.
Condition
- Huntington Disease
Eligibility
- Eligible Ages
- Between 18 Years and 85 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- Intervention 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.
- Primary Purpose
- Device Feasibility
- Masking
- Double (Participant, Investigator)
- Masking Description
- 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 method has been shown to be reliable and indistinguishable from active treatment. 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.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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 but the electric current will be applied only in the first and final 30s of stimulation. |
|
Recruiting Locations
University of Texas Health Science Center at San Antonio
San Antonio 4726206, Texas 4736286 78229
San Antonio 4726206, Texas 4736286 78229
More Details
- Status
- Recruiting
- Sponsor
- The University of Texas Health Science Center at San Antonio
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 with functional and structural neuroimaging techniques.