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

Overview

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

Interventions

• Device active tDCS
  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 fr

Primary outcome measures

• Feasibility as assessed by the number of participants included and who successfully completed the protocol [Time frame: through study completion, an average of 8 weeks]
• Change in acceptability of the treatment as assessed by the tDCS acceptability questionnaire [Time frame: Baseline, week 2, week 4, week 8]
• Change in safety of home-based tDCS treatment as as assessed by the tDCS side effect questionnaire [Time frame: week 2, week 4]

Secondary outcome measures (9)

• Change in Motor function as assessed by the Unified Huntington Disease Rating Scale (UHDRS) [Time frame: Baseline,week4]
• Change in Cognitive function as assessed by the Unified Huntington Disease Rating Scale (UHDRS) [Time frame: Baseline,week4]
• Change in Behavior as assessed by the Unified Huntington Disease Rating Scale (UHDRS) [Time frame: Baseline,week4]
• Change in apathy as assessed by the Brief Dimensional Apathy Scale (bDAS) [Time frame: Baseline, week 2, week 4, week 8]
• Change in depression as assessed by the Patient Health Questionnaire (PHQ-9) [Time frame: Baseline, week 2, week 4, week 8]
• Change in irritability as assessed by the Irritability Questionnaire [Time frame: Baseline, week 2, week 4, week 8]
• Change in cognition as assessed by the Montreal Cognitive Assessment (MoCA) [Time frame: Baseline, week 2, week 4, week 8]
• Change in anxiety and depressive symptoms as assessed by the Hospital Anxiety and Depression Scale (HADS) [Time frame: Baseline, week 2, week 4, week 8]
• Change in behavioral symptoms as assessed by the Problem Behaviours Assessment (PBA-s) [Time frame: Baseline, 2 weeks of treatment, at the end of treatment (week 4) and 4 weeks post-treatment.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• The University of Texas Health Science Center at Houston — Houston

Identifiers

NCT: NCT05326451 · HSC-MS-21-1065

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗