RecruitingNot ApplicableNCT05326451

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


Sponsor

The University of Texas Health Science Center, Houston

Enrollment

10 participants

Start Date

Jun 21, 2023

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria7

  • Participant:
  • 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.
  • willingness to participate in the study

Exclusion Criteria10

  • 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:
  • 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.

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Interventions

DEVICEactive 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 from Monday through Friday for four consecutive weeks.


Locations(1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States

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NCT05326451


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