Transcranial Direct Current Stimulation (tDCS) and Cognitive Processing

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2015 by Johns Hopkins University
Sponsor:
Information provided by (Responsible Party):
Barry Gordon, M.D., Ph.D., Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01602263
First received: May 14, 2012
Last updated: August 31, 2015
Last verified: August 2015

May 14, 2012
August 31, 2015
January 2009
January 2025   (final data collection date for primary outcome measure)
Indices of cognitive function [ Time Frame: The average time frame is 1 hour ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT01602263 on ClinicalTrials.gov Archive Site
  • Persistence of cognitive enhancements following tDCS [ Time Frame: The average time frame is 1 hour ] [ Designated as safety issue: No ]
  • Initiation, endurance and cessation of skin sensations caused by tDCS [ Time Frame: The average time frame is 1 hour ] [ Designated as safety issue: No ]
    The initiation, endurance and cessation of skin sensations caused by tDCS will be examined in order to develop a more effective blinding procedure.
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Transcranial Direct Current Stimulation (tDCS) and Cognitive Processing
Transcranial Direct Current Stimulation (tDCS)and Cognitive Processing

This research is being done to determine whether transcranial direct current stimulation (tDCS) can improve certain mental abilities. In this research, battery powered device is used to deliver very weak electrical current to the surface of the scalp while participants complete cognitive tasks. Our aim is to find out whether tDCS will improve task performance in both healthy adults and those with neurological impairment.

Participants enrolled into this study may be asked to do the following:

  • Grant permission for the researchers to view medical records associated with their language/cognitive difficulties (if applicable.
  • Complete a questionnaire, provide a health history, and take some pencil-and-paper tests of problem-solving and memory in order to verify eligibility to participate and to able to safely undergo the experimental procedures.
  • Complete several tasks (i.e., saying words out loud, naming objects, drawing designs, remembering lists of words, searching for images or letters, and/or completing puzzles) based upon a number of cognitive functions such as language, memory, vision, processing, and perception.
  • Wear electrodes that will be placed on the scalp with a large rubberized band. These electrodes will administer very weak electrical current (tDCS) from a battery powered device for 20 to 60 minutes.
  • Participation in several study conditions. The exact conditions and their order will be randomized. Under some conditions, participants may receive active stimulation (tDCS) and under other conditions, they may receive sham stimulation.
  • The experimental sessions will last approximately 2 hours and participants may be asked to have more than one testing session in a day or to return for additional sessions.
  • Have a Magnetic Resonance Imaging (MRI) brain scan.
Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
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Non-Probability Sample

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

  1. Healthy adults with no known deficits in cognition
  2. Adults with acquired language problems (i.e., stroke, mental illness)
  3. Adults with developmental language delays
  • Aphasia
  • Autism
  • Schizophrenia
Procedure: Transcranial Direct Current Stimulation (tDCS)
Anodal, Cathodal or Sham tDCS.
  • Controls
    Healthy Controls with no known cognitive impairment will have Transcranial Direct Current Stimulation (tDCS) administered and receive either Anodal, Cathodal or Sham tDCS.
    Intervention: Procedure: Transcranial Direct Current Stimulation (tDCS)
  • Individuals with schizophrenia
    Individuals with schizophrenia and first-degree relatives will have Transcranial Direct Current Stimulation (tDCS) administered and receive either Anodal, Cathodal or Sham tDCS.
    Intervention: Procedure: Transcranial Direct Current Stimulation (tDCS)
  • Individuals with aphasia
    Individuals with aphasia will have Transcranial Direct Current Stimulation (tDCS) administered and receive either Anodal, Cathodal or Sham tDCS.
    Intervention: Procedure: Transcranial Direct Current Stimulation (tDCS)
  • Individuals with high-functioning autism
    Individuals with high-functioning autism will have Transcranial Direct Current Stimulation (tDCS) administered and receive either Anodal, Cathodal or Sham tDCS.
    Intervention: Procedure: Transcranial Direct Current Stimulation (tDCS)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
December 2030
January 2025   (final data collection date for primary outcome measure)

Eligibility Criteria by Study Group

Normal Controls Inclusion Criteria:

  • Right handed (as determined by the Edinburgh battery)
  • English as native language

Normal Controls Exclusion Criteria:

  • Appreciable deficits in hearing
  • Appreciable problems with articulation
  • Schizophrenia, bipolar disorder, or major depression
  • Appreciable accent
  • Any neurological disorder associated with cognitive impairment or neuroanatomic abnormality
  • Language-based learning disorder
  • Any implanted metal device (precludes use of tDCS)
  • Any implanted cardiac pacemaker
  • Dementia or Mini-Mental State Exam < 24
  • Estimated verbal intelligence < 70

Aphasia Group Inclusion Criteria:

  • Right handed (as determined by the Edinburgh battery)
  • English as native language
  • History of acquired left-hemisphere dysfunction

Aphasia Group Exclusion Criteria:

  • Appreciable deficits in hearing
  • Schizophrenia, bipolar disorder, or major depression
  • Appreciable accent
  • Language-based learning disorder
  • Any implanted metal device
  • Any implanted cardiac pacemaker
  • Mini-Mental State Exam < 21/27 (omitting naming & items)
  • Estimated verbal intelligence < 70

Schizophrenia/First-degree Family Members Inclusion Criteria:

  • Right handed (as determined by the Edinburgh battery)
  • English as native language
  • Diagnosis of schizophrenia (SZ) or bipolar disorder (BD)
  • First degree family member of individual with SZ or BD

Schizophrenia/First-degree Family Members Exclusion Criteria:

  • Appreciable deficits in hearing
  • Appreciable accent
  • Any implanted metal device (precludes use of tDCS)
  • Any implanted cardiac pacemaker
  • Dementia or Mini-Mental State Exam < 24
  • Estimated verbal intelligence < 70

High-functioning Autism Inclusion Criteria:

  • Right handed (as determined by the Edinburgh battery)
  • English as native language
  • Diagnosis of High-functioning autism (i.e., Asperger's)

High-functioning Autism Exclusion Criteria:

  • Appreciable deficits in hearing
  • Schizophrenia, bipolar disorder, or major depression
  • Appreciable accent
  • Any implanted metal device
  • Any implanted cardiac pacemaker
  • Dementia or Mini-Mental State Exam < 24
  • Estimated verbal intelligence < 70
Both
18 Years to 79 Years
Yes
Contact: Julia Hernandez 410-955-7789
United States
 
NCT01602263
15657
Yes
Barry Gordon, M.D., Ph.D., Johns Hopkins University
Johns Hopkins University
Not Provided
Principal Investigator: Barry Gordon, M.D., Ph.D. The Johns Hopkins University School of Medicine
Johns Hopkins University
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP