The Effect of tDCS on Subcortical Brain Functioning

Overview

This research is being done to determine whether transcranial direct current stimulation (tDCS) can improve certain abilities related to cognition, emotion and/or physical functioning in individuals with subcortical brain damage.

Full Title of Study: “The Effect of Transcranial Direct Current Stimulation on Subcortical Brain Functioning”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: October 9, 2018

Detailed Description

While cortical brain structures are thought to be responsible for higher level cognitive functioning (i.e., perception, thoughts, language, memory, attention, and processing), subcortical brain regions (i.e., amygdala, midbrain, hippocampus, and thalamus) are generally believed to be responsible for more fundamental bases of such functions. A significant fraction of the population suffer from disabling disorders and diseases (i.e., Parkinson's disease, subcortical dementia, hypoxic brain damage) that affect subcortical areas. Despite their prevalence, very little success has been achieved in treating such impairments effectively. This study has two main goals. One is to examine the effect of stimulation on a variety of subcortical functions (i.e., level of alertness, mood, cognition, and motor responding). A second goal is to examine the effects of varying some of the stimulus parameters of tDCS, notably the placement of the electrodes and the duration and frequency of application of current. Adult participants with a confirmed diagnosis of subcortical brain damage, as well as healthy adults will be randomly assigned to anodal and cathodal stimulation in a counterbalanced order, and both will engage in simple behavioral tasks and/or physiological monitoring. These tasks will be specific to the deficit of interest.

Interventions

  • Procedure: Transcranial Direct Current Stimulation (tDCS)
    • Anodal, Cathodal or Sham tDCS

Arms, Groups and Cohorts

  • Experimental: Active Stimulation
    • Transcranial direct current stimulation using Anodal or Cathodal stimulation over the area of interest
  • Sham Comparator: Sham Stimulation
    • Transcranial direct current stimulation (tDCS) that is ramped up and ramped down providing the sensation of tDCS without delivering the full amount of tDCS.

Clinical Trial Outcome Measures

Primary Measures

  • Improvement in motor functioning
    • Time Frame: 1 month
  • Improvement in level of consciousness and alertness
    • Time Frame: 1 month
  • Improvement in cognitive functioning
    • Time Frame: 1 month

Participating in This Clinical Trial

Inclusion Criteria

  • Fluent in the English language – History of subcortical brain damage (patient group only) – No known neurological or cognitive impairment (control group only) Exclusion Criteria:
  • Appreciable deficits in hearing – Schizophrenia, bipolar disorder, or major depression (normal controls only) – Any neurological disorder associated with cognitive impairment or neuroanatomic abnormality (normal controls only) – Language-based learning disorder (normal controls only) – Dementia or Mini-Mental State Exam <24 for normal control participants – Any implanted metal device (precludes use of tDCS) – Any implanted cardiac pacemaker
  • Gender Eligibility: All

    Minimum Age: 18 Years

    Maximum Age: 79 Years

    Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

    Investigator Details

    • Lead Sponsor
      • Johns Hopkins University
    • Provider of Information About this Clinical Study
      • Sponsor
    • Overall Official(s)
      • Barry Gordon, M.D., Ph.D., Principal Investigator, Johns Hopkins University

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