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

Launched by THE UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT SAN ANTONIO · Feb 20, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a treatment called transcranial direct current stimulation (tDCS) on the cognitive and behavioral symptoms of Huntington's Disease, a condition that affects movement, thinking, and mood. The researchers want to see if daily sessions using a tDCS device, which participants will use at home for about 30 minutes each day, can help improve symptoms. Participants will also answer questions about their experience and undergo some thinking tests at the study center. Caregivers will be involved too, as they will provide additional information about the participants' health and behavior.

To be eligible for the study, participants must be between 18 and 85 years old, have a confirmed diagnosis of Huntington's Disease, and show mild to moderate behavioral symptoms. They should also be stable on their medications for at least a month and have a caregiver who can help during the sessions. The trial is not yet recruiting participants, but it aims to gather important information that could help improve the lives of those living with Huntington's Disease.

Gender

ALL

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
• • 1. Any individual who does not meet all the inclusion criteria