Effects of Transcranial Direct Current Stimulation in Individuals With Schizophrenia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Johns Hopkins University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Barry Gordon, M.D., Ph.D., Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01607840
First received: May 24, 2012
Last updated: June 1, 2012
Last verified: June 2012
  Purpose

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 Intervention
Schizophrenia
Procedure: transcranial direct current stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effects of Transcranial Direct Current Stimulation in Individuals With Schizophrenia

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Cognitive Test Performance [ Time Frame: The average time frame is approximately 2 hours ] [ Designated as safety issue: No ]
    Cognitive test performance by subjects will be evaluated upon completion of enrollment to determine if tDCS improved performance on cognitive tests.


Secondary Outcome Measures:
  • Functional Connectivity Changes Associated with tDCS [ Time Frame: Time frame is approximately 2 hours ] [ Designated as safety issue: No ]
    Pre- and post- stimulation MRI's will be conducted to determine if tDCS is associated with changes in neural activity.


Estimated Enrollment: 12
Study Start Date: June 2012
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Anodal Stimulation
tDCS 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
tDCS 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
tDCS 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01607840

Contacts
Contact: Mark Varvaris 410-502-6345 mvarvar2@jhmi.edu

Locations
United States, Maryland
Department of Neurology 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 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: NCT01607840     History of Changes
Other Study ID Numbers: 15657-S
Study First Received: May 24, 2012
Last Updated: June 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Schizophrenia
Cognitive Improvement
tDCS
stimulation

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on October 23, 2014