Effects of Transcranial Direct Current Stimulation in Individuals With Schizophrenia

NCT ID: NCT01607840

Last Updated: 2015-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2014-09-30

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.

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Anodal Stimulation

transcranial direct current stimulation using Anodal stimulation over the area of interest

Group Type EXPERIMENTAL

transcranial direct current stimulation

Intervention Type PROCEDURE

delivery of transcranial direct current stimulation or sham for 20 to 60 minutes

Cathodal

transcranial direct current stimulation using cathodal stimulation over the brain area of interest

Group Type EXPERIMENTAL

transcranial direct current stimulation

Intervention Type PROCEDURE

delivery of transcranial direct current stimulation or sham for 20 to 60 minutes

Sham Stimulation

transcranial direct current stimulation that is ramped up and ramped down providing the sensation of tDCS without actually delivering tDCS

Group Type SHAM_COMPARATOR

transcranial direct current stimulation

Intervention Type PROCEDURE

delivery of transcranial direct current stimulation or sham for 20 to 60 minutes

Interventions

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transcranial direct current stimulation

delivery of transcranial direct current stimulation or sham for 20 to 60 minutes

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Barry Gordon, M.D., Ph.D.

Editor-in-Chief, Cognitive and Behavioral Neurology/Therapeutic Cognitive Neuroscience Professor/Professor of Neurology and Cognitive Science

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Barry Gordon

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Department of Neurology

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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15657-S

Identifier Type: -

Identifier Source: org_study_id

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