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Transcranial Direct Current Stimulation Influences on Cognitive Inhibition in Schizophrenia

Primary Purpose

Schizophrenia

Status
Terminated
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
transcranial direct current stimulation
sham tDCS
Sponsored by
Bar-Ilan University, Israel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenic patients, tDCS, Executive functions, Dorsolateral prefrontal cortex

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • must be 18 years old or above.
  • Clinical diagnosis of schizophrenia or schizoaffective disorder
  • must be with a stable mental status as demonstrated by a stable Positive and -Negative Symptom Score (PANSS) score over a period of 2 weeks.
  • must have no medication changes in the 2 weeks prior to obtaining informed consent.
  • must be able to give informed consent for the trial.

Exclusion Criteria:

  • Unwilling or unable, in the opinion of the Investigator, to comply with study instructions
  • Pregnant or breast-feeding.
  • current DSM-V substance or alcohol abuse.
  • Concurrent delirium
  • mental retardation
  • drug-induced psychosis
  • history of clinically significant brain trauma documented by CT or MRI.
  • epilepsy or had seizures 6 months prior the beginning of the study

Sites / Locations

  • The Chaim Sheba Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

bilateral Anodal-L/R Cathodal-R/L tDCS

Sham tDCS

Arm Description

bilateral Anodal-left and cathodal-right tDCS over DLPFC or bilateral Anodal-right and cathodal-left tDCS over DLPFC. Intervention: Device: transcranial direct current stimulation

Sham tDCS

Outcomes

Primary Outcome Measures

Progression score on cognitive tasks
Improve performance in cognitive tasks in particular, higher scores on the MATRICS Consensus Cognitive Battery in the post vs. before intervention tests.

Secondary Outcome Measures

Full Information

First Posted
October 12, 2013
Last Updated
April 25, 2018
Sponsor
Bar-Ilan University, Israel
Collaborators
Sheba Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01971073
Brief Title
Transcranial Direct Current Stimulation Influences on Cognitive Inhibition in Schizophrenia
Official Title
Transcranial Direct Current Stimulation Influences on Cognitive Inhibition in Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Terminated
Why Stopped
Difficulty in financing the research
Study Start Date
January 2015 (undefined)
Primary Completion Date
March 7, 2018 (Actual)
Study Completion Date
March 7, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bar-Ilan University, Israel
Collaborators
Sheba Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A deficit in cognitive suppression is a trait of patients with schizophrenia. Cognitive suppression is the ability to control or suppress irrelevant responses and to adopt relevant responses instead. The purpose of this study is to investigate the effects of transcranial direct current stimulation (tDCS) on information suppression in schizophrenic patients. This is a noninvasive technique of brain stimulation that induces prolonged functional changes in the cerebral cortex through the application of a weak direct current to the scalp (Nitsche & Paulus, 2001). The aim of this study is to test whether bilateral tDCS over the dorsolateral prefrontal cortex (DLPFC) differentially modify performance on several cognitive tasks.
Detailed Description
A deficit in cognitive suppression is a trait of patients with schizophrenia. Cognitive suppression is the ability to control or suppress irrelevant information and to adopt relevant responses instead. This ability is a basic skill which is essential to maintain a normal well-adjusted life. We need to suppress distracting information in order to focus attention, to suppress irrelevant cues in order to retrieve particular memories, and to suppress habitual responses in order to make adaptive choices (Dillon & Pizzagalli, 2007). The purpose of this study is to investigate the effects of transcranial direct current stimulation (tDCS) on information suppression in schizophrenic patients. This is a noninvasive technique of brain stimulation that induces prolonged functional changes in the cerebral cortex through the application of a weak direct current to the scalp (Nitsche & Paulus, 2001; Nitsche et al., 2003, 2004; Antal et al., 2004). The aim of this study is to test whether anodal and cathodal tDCS differentially modify performance on several cognitive tasks when applied to the left/right dorsolateral prefrontal cortex (DLPFC). Sixty patients will be divided into four groups: 1) 15 schizophrenic subjects in a tDCS treatment group; 2) 15 schizophrenic subjects in a sham tDCS group; 3) 15 healthy subjects in a tDCS treatment group; 4) 15 healthy subjects in a sham tDCS group. All participants will complete baseline tests including an n-back test, the Hayling test and metaphoric comprehension test. The schizophrenic subjects only, will complete a bank of cognitive tests as a baseline (MATRICS Consensus Cognitive Battery (MCCB). The first meeting for the schizophrenic subjects only will be used to determine the best stimulation area (right/left DLPFC) and type (anodal/ cathodal). Schizophrenic subjects in both the treatment and the control groups will undergo six treatment sessions in total. The cognitive tests will be given to all participants once again at the end of the study. In order to evaluate improvement between the pre-test and the post-test, differences in reaction times and error rate will be calculated for each participant. This study is important for few reasons. First, this study focus on the difficulty of suppressing irrelevant information, executive function ability essential to leading a normal life. Special populations, and specifically people with schizophrenia, have difficulty suppressing irrelevant information, and a correlation has been noted between this characteristic and weak executive functioning capabilities. In this study we evaluate the potential of minimizing these difficulties through use of tDCS. This particular tool was chosen for the study because it is easy to use, non-invasive, and painless. Research has shown that tDCS stimulation of the DLPFC can improve performance in cognitive tasks, a result that has not been mirrored through use of medications. Second, in recognition of the heterogeneity of schizophrenic patients (substantiated by the fact that the success of other treatments varies from patient to patient), our study will perform tests to identify the preferred stimulation region, DLPFC left/right. The results will help determine more specifically if there is a degree of heterogeneity in terms of the region responsible for suppressing irrelevant information . Related to this, we will be able to assess the impact of stimulation, including whether or not stimulation benefits all schizophrenic patients or, alternatively, if there are unknown variables involved which determine the relative success of this treatment amongst individuals. In addition, we will be able to explore differences or correlations between healthy subjects' verbal abilities in relation to the various tests conducted, and assess the impact of these tests on healthy subjects' cognitive inhibition and working memory. Finally, this study is critical because if the treatment method proves to be successful, we would be able to extend this study to other populations that have difficulties with executive functioning, and in addition, to examine the effect of electrical stimulation on other cognitive abilities.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
schizophrenic patients, tDCS, Executive functions, Dorsolateral prefrontal cortex

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
bilateral Anodal-L/R Cathodal-R/L tDCS
Arm Type
Experimental
Arm Description
bilateral Anodal-left and cathodal-right tDCS over DLPFC or bilateral Anodal-right and cathodal-left tDCS over DLPFC. Intervention: Device: transcranial direct current stimulation
Arm Title
Sham tDCS
Arm Type
Sham Comparator
Arm Description
Sham tDCS
Intervention Type
Device
Intervention Name(s)
transcranial direct current stimulation
Other Intervention Name(s)
Active Comparator: sham tDCS
Intervention Description
arm Participants will receive bilateral anodal-left cathodal-right tDCS or anodal-right cathodal-left tDCS over the DLPFC. The following parameters will be used: stimulation intensity of 2 milliAmps for 20 minutes (6 consecutive sessions ).
Intervention Type
Device
Intervention Name(s)
sham tDCS
Intervention Description
the sham tDCS group. Neuropsychological testing and symptom ratings will be conducted at baseline and 4 weeks after the end of treatment
Primary Outcome Measure Information:
Title
Progression score on cognitive tasks
Description
Improve performance in cognitive tasks in particular, higher scores on the MATRICS Consensus Cognitive Battery in the post vs. before intervention tests.
Time Frame
two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: must be 18 years old or above. Clinical diagnosis of schizophrenia or schizoaffective disorder must be with a stable mental status as demonstrated by a stable Positive and -Negative Symptom Score (PANSS) score over a period of 2 weeks. must have no medication changes in the 2 weeks prior to obtaining informed consent. must be able to give informed consent for the trial. Exclusion Criteria: Unwilling or unable, in the opinion of the Investigator, to comply with study instructions Pregnant or breast-feeding. current DSM-V substance or alcohol abuse. Concurrent delirium mental retardation drug-induced psychosis history of clinically significant brain trauma documented by CT or MRI. epilepsy or had seizures 6 months prior the beginning of the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nira Mashal, Ph.D.
Organizational Affiliation
Bar-Ilan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Chaim Sheba Medical Center
City
Ramat-Gan
ZIP/Postal Code
52621
Country
Israel

12. IPD Sharing Statement

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Transcranial Direct Current Stimulation Influences on Cognitive Inhibition in Schizophrenia

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