Effects of Transcranial Direct Current Stimulation in Individuals With Schizophrenia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Transcranial Direct Current Stimulation in Individuals With Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Procedure: transcranial direct current stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anodal Stimulation<br>transcranial direct current stimulation using Anodal stimulation over the area of interest | Procedure: transcranial direct current stimulation<br>* delivery of transcranial direct current stimulation or sham for 20 to 60 minutes<br>|
| Experimental: Cathodal<br>transcranial direct current stimulation using cathodal stimulation over the brain area of interest | Procedure: transcranial direct current stimulation<br>* delivery of transcranial direct current stimulation or sham for 20 to 60 minutes<br>|
| Sham Comparator: Sham Stimulation<br>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<br>* delivery of transcranial direct current stimulation or sham for 20 to 60 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive Test Performance | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, Cognitive Improvement, tDCS, stimulation