The Effect of tDCS on Subcortical Brain Functioning

This study is enrolling participants by invitation only.
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: August 31, 2015
Last verified: August 2015
  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: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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:

Primary Outcome Measures:
  • Improvement in motor functioning [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Improvement in level of consciousness and alertness [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Improvement in cognitive functioning [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: February 2012
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: September 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Barry Gordon, M.D., Ph.D. The Johns Hopkins University School of Medicine
  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: August 31, 2015
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 03, 2015