NCT01971073

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable schizophrenia

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2013

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 29, 2013

Completed
1.2 years until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2018

Completed
Last Updated

April 27, 2018

Status Verified

April 1, 2018

Enrollment Period

3.2 years

First QC Date

October 12, 2013

Last Update Submit

April 25, 2018

Conditions

Schizophrenia

Keywords

schizophrenic patientstDCSExecutive functionsDorsolateral prefrontal cortex

Outcome Measures

Primary Outcomes (1)

  • 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.

    two years

Study Arms (2)

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

EXPERIMENTAL

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

Device: transcranial direct current stimulation

Sham tDCS

SHAM COMPARATOR

Sham tDCS

Device: sham tDCS

Interventions

transcranial direct current stimulationDEVICE

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 ).

Also known as: Active Comparator: sham tDCS
bilateral Anodal-L/R Cathodal-R/L tDCS
sham tDCSDEVICE

the sham tDCS group. Neuropsychological testing and symptom ratings will be conducted at baseline and 4 weeks after the end of treatment

Sham tDCS

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chaim Sheba Medical Center

Ramat Gan, 52621, Israel

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Nira Mashal, Ph.D.

    Bar Ilan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Mashal, PI

Study Record Dates

First Submitted

October 12, 2013

First Posted

October 29, 2013

Study Start

January 1, 2015

Primary Completion

March 7, 2018

Study Completion

March 7, 2018

Last Updated

April 27, 2018

Record last verified: 2018-04

Locations

IL(1)