Effects of Transcranial Direct Current Stimulation in Individuals With Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
transcranial direct current stimulation
Sponsored by

About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Cognitive Improvement, tDCS, stimulation
Eligibility 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
Sites / Locations
- Department of Neurology
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Sham Comparator
Arm Label
Anodal Stimulation
Cathodal
Sham Stimulation
Arm Description
transcranial direct current stimulation using Anodal stimulation over the area of interest
transcranial direct current stimulation using cathodal stimulation over the brain area of interest
transcranial direct current stimulation that is ramped up and ramped down providing the sensation of tDCS without actually delivering tDCS
Outcomes
Primary Outcome Measures
Cognitive Test Performance
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
Pre- and post- stimulation MRI's will be conducted to determine if tDCS is associated with changes in neural activity.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01607840
Brief Title
Effects of Transcranial Direct Current Stimulation in Individuals With Schizophrenia
Official Title
Effects of Transcranial Direct Current Stimulation in Individuals With Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Cognitive Improvement, tDCS, stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anodal Stimulation
Arm Type
Experimental
Arm Description
transcranial direct current stimulation using Anodal stimulation over the area of interest
Arm Title
Cathodal
Arm Type
Experimental
Arm Description
transcranial direct current stimulation using cathodal stimulation over the brain area of interest
Arm Title
Sham Stimulation
Arm Type
Sham Comparator
Arm Description
transcranial direct current stimulation that is ramped up and ramped down providing the sensation of tDCS without actually delivering tDCS
Intervention Type
Procedure
Intervention Name(s)
transcranial direct current stimulation
Intervention Description
delivery of transcranial direct current stimulation or sham for 20 to 60 minutes
Primary Outcome Measure Information:
Title
Cognitive Test Performance
Description
Cognitive test performance by subjects will be evaluated upon completion of enrollment to determine if tDCS improved performance on cognitive tests.
Time Frame
The average time frame is approximately 2 hours
Secondary Outcome Measure Information:
Title
Functional Connectivity Changes Associated with tDCS
Description
Pre- and post- stimulation MRI's will be conducted to determine if tDCS is associated with changes in neural activity.
Time Frame
Time frame is approximately 2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barry Gordon
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurology
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effects of Transcranial Direct Current Stimulation in Individuals With Schizophrenia
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