Home-based tDCS to help thinking and behavior in Huntington's disease
Home-based TDCS for Cognitive and Behavioral Symptoms in Huntington's Disease: a Pilot Feasibility and Mechanistic Study
This project will test whether daily at-home transcranial direct current stimulation (tDCS) can help thinking and behavioral symptoms in adults with early-to-moderate Huntington's disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | The University of Texas Health Science Center at San Antonio Academic / other |
| Locations | 1 site (San Antonio, Texas) |
| Trial ID | NCT06843252 on ClinicalTrials.gov |
What this trial studies
This interventional protocol gives eligible participants a home tDCS device to use for 30 minutes each day, with a caregiver present, and compares active stimulation to sham stimulation. Participants will answer questionnaires remotely by web conference, and caregivers will complete parallel questionnaires about symptoms. Study staff will ask participants to return to the center for in-person follow-up visits with cognitive testing and additional assessments. The study also includes measures designed to explore underlying neurobiological mechanisms of tDCS in Huntington's disease.
Who should consider this trial
Good fit: Adults aged 18–85 with a confirmed Huntington's disease mutation (early to moderate stages), mild-to-moderate behavioral symptoms, stable medications, and a caregiver willing to be present and complete questionnaires are ideal candidates.
Not a fit: Patients with advanced disease or very severe behavioral symptoms, those without a caregiver or unable to attend required in-person follow-up visits, or those with unstable medications are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, home tDCS could reduce behavioral symptoms and improve cognitive function, helping patients with daily activities and quality of life.
How similar studies have performed: Small pilot studies of tDCS in Huntington's and related neurological conditions have shown mixed or modest benefits, so the approach is promising but not yet proven.
Eligibility criteria
Show full inclusion / exclusion 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 1\. Any individual who does not meet all the inclusion criteria
Where this trial is running
San Antonio, Texas
- University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Thiago Macedo e Cordeiro, MD, MSc — The University of Texas Health Science Center at San Antonio
- Study coordinator: Thiago Macedo e Cordeiro, MD, MSc
- Email: macedoecorde@uthscsa.edu
- Phone: 210-450-7055
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.