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Effects of Transcranial Direct Current Stimulation in Individuals With Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01607840
Recruitment Status : Completed
First Posted : May 30, 2012
Last Update Posted : September 1, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Schizophrenia Procedure: transcranial direct current stimulation

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effects of Transcranial Direct Current Stimulation in Individuals With Schizophrenia
Study Start Date : June 2012
Primary Completion Date : September 2014
Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01607840


Locations
United States, Maryland
Department of Neurology
Baltimore, Maryland, United States, 21231
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Barry Gordon Johns Hopkins University
More Information

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: NCT01607840     History of Changes
Other Study ID Numbers: 15657-S
First Posted: May 30, 2012    Key Record Dates
Last Update Posted: September 1, 2015
Last Verified: August 2015

Keywords provided by Barry Gordon, M.D., Ph.D., Johns Hopkins University:
Schizophrenia
Cognitive Improvement
tDCS
stimulation

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders