Effects of Transcranial Direct Current Stimulation in Individuals With Schizophrenia

August 31, 2015 updated by: Barry Gordon, M.D., Ph.D., Johns Hopkins University
This research is being done to determine whether transcranial direct current stimulation (tDCS) can improve certain mental abilities and alter functional connectivity in individuals with Schizophrenia. 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. Participants also receive a brain scan before and after stimulation. Our aim is to determine if tDCS can improve mental abilities in individuals with schizophrenia.

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

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 (e.g., 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.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

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

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of Schizophrenia
  • English as a native language

Exclusion Criteria:

  • appreciable deficits in hearing or vision
  • appreciable accent
  • any implanted metal device or pacemaker
  • Dementia or Mini Mental Exam below 24
  • History of Seizures

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Anodal Stimulation
transcranial direct current stimulation using Anodal stimulation over the area of interest
Procedure: transcranial direct current stimulation
delivery of transcranial direct current stimulation or sham for 20 to 60 minutes
Experimental: Cathodal
transcranial direct current stimulation using cathodal stimulation over the brain area of interest
Procedure: transcranial direct current stimulation
delivery of transcranial direct current stimulation or sham for 20 to 60 minutes
Sham Comparator: Sham Stimulation
transcranial direct current stimulation that is ramped up and ramped down providing the sensation of tDCS without actually delivering tDCS
Procedure: transcranial direct current stimulation
delivery of transcranial direct current stimulation or sham for 20 to 60 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive Test Performance
Time Frame: The average time frame is approximately 2 hours
Cognitive test performance by subjects will be evaluated upon completion of enrollment to determine if tDCS improved performance on cognitive tests.
The average time frame is approximately 2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Connectivity Changes Associated with tDCS
Time Frame: Time frame is approximately 2 hours
Pre- and post- stimulation MRI's will be conducted to determine if tDCS is associated with changes in neural activity.
Time frame is approximately 2 hours

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, Johns Hopkins University

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

June 1, 2012

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

May 24, 2012

First Submitted That Met QC Criteria

May 25, 2012

First Posted (Estimate)

May 30, 2012

Study Record Updates

Last Update Posted (Estimate)

September 1, 2015

Last Update Submitted That Met QC Criteria

August 31, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15657-S

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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