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The Effect of tDCS on Subcortical Brain Functioning

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01602276
Recruitment Status : Terminated (Difficulty identifying appropriate patients)
First Posted : May 18, 2012
Last Update Posted : December 20, 2018
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
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 or disease Intervention/treatment Phase
Brain Damage, Chronic Procedure: Transcranial Direct Current Stimulation (tDCS) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Effect of Transcranial Direct Current Stimulation on Subcortical Brain Functioning
Actual Study Start Date : February 2012
Actual Primary Completion Date : October 9, 2018
Actual Study Completion Date : October 10, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Active Stimulation
Transcranial direct current stimulation using Anodal or Cathodal stimulation over the area of interest
Procedure: Transcranial Direct Current Stimulation (tDCS)
Anodal, Cathodal or Sham tDCS

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

Primary Outcome Measures :
  1. Improvement in motor functioning [ Time Frame: 1 month ]
  2. Improvement in level of consciousness and alertness [ Time Frame: 1 month ]
  3. Improvement in cognitive functioning [ Time Frame: 1 month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01602276

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United States, Maryland
Department of Neurology; Cognitive Neurology/Neuropsychology
Baltimore, Maryland, United States, 21231
Sponsors and Collaborators
Johns Hopkins University
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Principal Investigator: Barry Gordon, M.D., Ph.D. Johns Hopkins University

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Responsible Party: Johns Hopkins University Identifier: NCT01602276     History of Changes
Other Study ID Numbers: NA_00047863
First Posted: May 18, 2012    Key Record Dates
Last Update Posted: December 20, 2018
Last Verified: December 2018

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

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