The Effect of tDCS on Subcortical Brain Functioning

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Barry Gordon, M.D., Ph.D., Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01602276
First received: May 14, 2012
Last updated: October 31, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Brain Damage, Chronic
Procedure: Transcranial Direct Current Stimulation (tDCS)

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Effect of Transcranial Direct Current Stimulation on Subcortical Brain Functioning

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Estimated Enrollment: 150
Study Start Date: February 2012
Estimated Study Completion Date: December 2015
Groups/Cohorts Assigned Interventions
Individuals w/ subcortical brain damage
Individuals with subcortical brain damage resulting from Parkinson's disease, subcortical dementia (i.e., Huntington's disease, Parkinson's related dementia, Lewy Body dementia), stroke, anoxia, or other brain injury.
Procedure: Transcranial Direct Current Stimulation (tDCS)
Anodal, Cathodal or Sham tDCS
Control Group
Healthy controls with no known cognitive deficits
Procedure: Transcranial Direct Current Stimulation (tDCS)
Anodal, Cathodal or Sham tDCS

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.

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

You must also belong to one of two groups to join this study:

  1. Healthy adults with no known deficits in cognition
  2. Adults with dysfunction due to damage to subcortical brain structures (i.e., thalamus, basal ganglia, limbic system, etc.) which may be associated with diagnoses such as diagnoses of Parkinson's disease, Korsakoff's syndrome, bipolar disorder, schizophrenia, depression, subcortical dementia, thalamic hypoperfusion, etc.).
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01602276

Locations
United States, Maryland
Department of Neurology; Cognitive Neurology/Neuropsychology
Baltimore, Maryland, United States, 21231
Sponsors and Collaborators
Johns Hopkins University
  More Information

No publications provided

Responsible Party: Barry Gordon, M.D., Ph.D., Editor-in-Chief, Cognitive and Behavioral Neurology/Therapeutic Cognitive Neuroscience Professor/Professor of Neurology and Cognitive Science, Johns Hopkins University, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01602276     History of Changes
Other Study ID Numbers: 47863
Study First Received: May 14, 2012
Last Updated: October 31, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Parkinson's disease
Lewy body dementia
Korsakoff's syndrome

Additional relevant MeSH terms:
Brain Damage, Chronic
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on April 14, 2014