Home-based brain stimulation for symptoms in Huntington's Disease

Home-based Transcranial Direct Current Stimulation Open Trial for Behavioral and Cognitive Symptoms in Huntington's Disease

This study is testing if a type of brain stimulation can help people with Huntington's Disease feel better by reducing symptoms like apathy, irritability, and depression.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: The University of Texas Health Science Center, Houston (other)
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT05326451 on ClinicalTrials.gov

What this trial studies

This study evaluates the feasibility, acceptability, and safety of using transcranial direct current stimulation (tDCS) in patients with Huntington's Disease (HD) who are in the early to middle stages of the condition. The intervention aims to assess its efficacy in alleviating behavioral and cognitive symptoms associated with HD, such as apathy, irritability, and depression. Participants will receive active tDCS while maintaining stable medication doses for at least one month prior to the study. Caregivers will also be involved to support participants throughout the process.

Who should consider this trial

Good fit: Ideal candidates include confirmed HD mutation carriers in early to moderate stages of the disease who exhibit mild to moderate behavioral symptoms.

Not a fit: Patients with unstable medical conditions, a history of epilepsy, or major cognitive disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a non-invasive treatment option to improve behavioral and cognitive symptoms in patients with Huntington's Disease.

How similar studies have performed: While the use of tDCS in other neurological conditions has shown promise, this specific application in Huntington's Disease is relatively novel and untested.

Eligibility criteria

Participant:

Inclusion Criteria:

* confirmed HD mutation carriers 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
* 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
* Have a caregiver willing to be present during tDCS sessions and answer questionnaires.

Exclusion Criteria:

* unstable medical conditions
* history of epilepsy
* metallic objects in the brain
* Have a caregiver willing to be present during tDCS sessions and answer questionnaires.
* clinical diagnosis of major cognitive disorder or dementia
* Have risk of suicidal behavior, defined as any suicidal behavior or suicidal ideation of type 4 or type 5 based on the Columbia-Suicide Severity Rating Scale (C-SSRS) in the 3 months prior to screening
* simultaneous participation in other clinical trial
* Individuals determined to be incapable of consent per past medical history or via assessment by the study staff at time of consent.

Caregiver:

Inclusion Criteria:

-willingness to participate in the study

Exclusion Criteria:

-motor/cognitive symptoms related to Alzheimer's disease or Huntington's disease that might impair the ability to assist the participant during the research study.

Where this trial is running

Houston, Texas

• The University of Texas Health Science Center at Houston — Houston, Texas, United States (RECRUITING)

Study contacts

• Principal investigator: Erin Stimming, MD — The University of Texas Health Science Center, Houston
• Study coordinator: Erin Stimming, MD

Conditions: Huntington Disease, transcranial direct current stimulation