Text Size

Transcranial Direct Current Stimulation (tDCS) and Cognitive Processing

This study is currently recruiting participants.
Verified May 2012 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: May 16, 2012
Last verified: May 2012
History of Changes
  Purpose

This research is being done to determine whether transcranial direct current stimulation (tDCS) can improve certain mental abilities. In this research, a 9 volt battery 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.


Condition Intervention
Aphasia
Autism
Schizophrenia
 Procedure: Transcranial Direct Current Stimulation (tDCS)

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Transcranial Direct Current Stimulation (tDCS)and Cognitive Processing

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Estimated Enrollment: 300
Study Start Date: January 2009
Estimated Study Completion Date: December 2017
Groups/Cohorts Assigned Interventions
Controls
Healthy Controls with no known cognitive impairment
 Procedure: Transcranial Direct Current Stimulation (tDCS)
Anodal, Cathodal or Sham tDCS.
Individuals with schizophrenia
Individuals with schizophrenia and first-degree relatives
 Procedure: Transcranial Direct Current Stimulation (tDCS)
Anodal, Cathodal or Sham tDCS.
Individuals with aphasia Procedure: Transcranial Direct Current Stimulation (tDCS)
Anodal, Cathodal or Sham tDCS.
Individuals with high-functioning autism Procedure: Transcranial Direct Current Stimulation (tDCS)
Anodal, Cathodal or Sham tDCS.

Detailed Description:

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 9 volt battery 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.
  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 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
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01602263

Contacts
Contact: Julia Hernandez 410-955-7789
Contact: Patrick Chambers 410-502-2640 pchambe3@jhmi.edu

Locations
United States, Maryland
Department of Neurology; Cognitive Neurology/Neuropsychology Recruiting
Baltimore, Maryland, United States, 21231
Principal Investigator: Barry Gordon, M.D., Ph.D.            
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
ClinicalTrials.gov Identifier: NCT01602263     History of Changes
Other Study ID Numbers: 15657
Study First Received: May 14, 2012
Last Updated: May 16, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Normal cognitive function
Aphasia
Autism
Schizophrenia

Additional relevant MeSH terms:
Aphasia
Autistic Disorder
Schizophrenia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
 Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on May 16, 2013