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

NCT05326451 | Recruiting FDA Device

• 1 other identifier: HSC-MS-21-1065
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess feasibility, acceptability, and safety of providing transcranial direct current stimulation( tDCS) to Huntingtons Disease (HD) patients in the early to middle stages and to assess the efficacy of tDCS for HD-related behavioral, cognitive and other symptoms

Conditions

Huntington Disease

Keywords

transcranial direct current stimulation

Outcome Measures

Primary Outcomes (3)

• Feasibility as assessed by the number of participants included and who successfully completed the protocol

  through study completion, an average of 8 weeks

• Change in acceptability of the treatment as assessed by the tDCS acceptability questionnaire

  Acceptability will be evaluated using a Likert scale (from 0 \[strongly disagree\] to 10 \[strongly agree\]) to answer ten affirmatives regarding the use of home based tDCS, with a total score range of 0-10 and a higher score indicating higher acceptability.

  Baseline, week 2, week 4, week 8

• Change in safety of home-based tDCS treatment as as assessed by the tDCS side effect questionnaire

  Safety will be assessed with a 10-item questionnaire about side effects, including itching, burning, headache, fatigue, and dizziness. Each question is scored form 0-10, with a total score range of 0-10 and a higher score indicating more side effects.

  week 2, week 4

Secondary Outcomes (9)

• Change in Motor function as assessed by the Unified Huntington Disease Rating Scale (UHDRS)

  Baseline,week4

• Change in Cognitive function as assessed by the Unified Huntington Disease Rating Scale (UHDRS)

  Baseline,week4

• Change in Behavior as assessed by the Unified Huntington Disease Rating Scale (UHDRS)

  Baseline,week4

• Change in apathy as assessed by the Brief Dimensional Apathy Scale (bDAS)

  Baseline, week 2, week 4, week 8

• Change in depression as assessed by the Patient Health Questionnaire (PHQ-9)

  Baseline, week 2, week 4, week 8

Study Arms (1)

active tDCS

EXPERIMENTAL

Device: active tDCS

Interventions

active tDCS DEVICE

Participants will receive active tDCS with a constant current intensity of 2mA. Anodal tDCS will be applied to the left dorsolateral prefrontal cortex, while cathodal electrode will be positioned on the right dorsolateral prefrontal cortex. Caregivers will help setting up and administering tDCS for participants with HD at home. tDCS will be applied for 30min at an intensity of 2mA, with 30 s ramping up and down. Sessions will be remotely supervised by trained research staff (RA), and will run from Monday through Friday for four consecutive weeks.

active tDCS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• willingness to participate in the study
• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Huntington Disease

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Chorea; Dyskinesias; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Erin Stimming, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin Stimming, MD

CONTACT

(713) 500-7033; Erin.E.Furr@uth.tmc.edu

Thiago Macedo e Cordeiro, MD

CONTACT

210-450-7055; macedoecorde@uthscsa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 5, 2022
• First Posted: April 13, 2022
• Study Start: June 21, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 11, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)