Clinical trial for Huntington Disease
Official title Home-based TDCS (Transcranial Direct Current Stimulation) for Cognitive and Behavioral Symptoms in Huntington's Disease
ClinicalTrials.gov ID: NCT06843252
What this study is testing
- What it's testing
- The study wants to learn whether daily tDCS can change behavioral symptoms in Huntington’s disease.
- Who it's for
- Adults who have Huntington’s disease and can use a home device.
- What's involved
- Participants will use a tDCS device for 30 minutes a day, answer questions with staff, attend center visits for tests, and complete online questionnaires. Caregivers will also fill out questionnaires.
- Time commitment
- The study lasts several weeks, with daily home sessions, periodic center visits, and online questionnaire periods.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join 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)...
- 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...
- stable doses of medications for at least one month.
- Ability of subject to understand and the willingness to sign a written informed consent document.
You likely can't join 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...
- 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.
See the full eligibility criteria
- 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.
- 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...
- 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 1\. Any individual who does not meet all the inclusion criteria
The study team makes the final eligibility decision.
Where it is enrolling
- San Antonio, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at San Antonio, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.