Transcranial Direct Current Stimulation (tDCS) and Cognitive Processing

Sponsor
Johns Hopkins University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01602263
Collaborator
(none)
300
1
263
1.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Transcranial Direct Current Stimulation (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 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Transcranial Direct Current Stimulation (tDCS)and Cognitive Processing
Study Start Date :
Jan 1, 2009
Anticipated Primary Completion Date :
Jan 1, 2025
Anticipated Study Completion Date :
Dec 1, 2030

Arms and Interventions

Arm Intervention/Treatment
Controls

Healthy Controls with no known cognitive impairment will have Transcranial Direct Current Stimulation (tDCS) administered and receive either Anodal, Cathodal or Sham tDCS.

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

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

Individuals with aphasia

Individuals with aphasia will have Transcranial Direct Current Stimulation (tDCS) administered and receive either Anodal, Cathodal or Sham tDCS.

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

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

Outcome Measures

Primary Outcome Measures

  1. Indices of cognitive function [The average time frame is 1 hour]

Secondary Outcome Measures

  1. Persistence of cognitive enhancements following tDCS [The average time frame is 1 hour]

  2. Initiation, endurance and cessation of skin sensations caused by tDCS [The average time frame is 1 hour]

    The initiation, endurance and cessation of skin sensations caused by tDCS will be examined in order to develop a more effective blinding procedure.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 79 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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

Locations

Site City State Country Postal Code
1 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., Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01602263
Other Study ID Numbers:
  • NA_00015657
  • 15657
First Posted:
May 18, 2012
Last Update Posted:
Dec 16, 2021
Last Verified:
Dec 1, 2021
Keywords provided by Johns Hopkins University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 16, 2021