Transcranial Direct Current Stimulation (tDCS) and Cognitive Processing

March 3, 2023 updated by: Johns Hopkins University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

307

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • Department of Neurology; Cognitive Neurology/Neuropsychology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Indices of cognitive function
Time Frame: The average time frame is 1 hour
The average time frame is 1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Persistence of cognitive enhancements following tDCS
Time Frame: The average time frame is 1 hour
The average time frame is 1 hour
Initiation, endurance and cessation of skin sensations caused by tDCS
Time Frame: 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.
The average time frame is 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Investigators

  • Principal Investigator: Barry Gordon, M.D., Ph.D., Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

December 23, 2017

Study Completion (Actual)

March 2, 2023

Study Registration Dates

First Submitted

May 14, 2012

First Submitted That Met QC Criteria

May 16, 2012

First Posted (Estimate)

May 18, 2012

Study Record Updates

Last Update Posted (Estimate)

March 7, 2023

Last Update Submitted That Met QC Criteria

March 3, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NA_00015657
  • 15657 (Other Identifier: Other)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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