Clinical trial NCT01607840: 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
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: Schizophrenia
Cognitive Improvement
tDCS
stimulation
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2012-05-30
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Cognitive Test Performance
timeFrame: The average time frame is approximately 2 hours
Secondary outcomes:
measure: Functional Connectivity Changes Associated with tDCS
timeFrame: Time frame is approximately 2 hours
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Department of Neurology
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Barry Gordon
role: PRINCIPAL_INVESTIGATOR
References: