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Electrical Brain Stimulation for Cognitive Impairment in Schizophrenia: a tDCS-fMRI Study

Primary Purpose

Schizophrenia, Cognitive Impairment

Status
Recruiting
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
transcranial direct current stimulation
Sponsored by
The National Brain Mapping Laboratory (NBML)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Schizophrenia focused on measuring Schizophrenia, cognitive impairment, Transcranial direct current stimulation, fMRI

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • men or women (18-50 yrs old) with a DSM 5 SCZ diagnosis,
  • If female, negative urine pregnancy test
  • significant cognitive impairment (1 SD below the norm on the working memory/executive functioning task performance)
  • feasibility for tDCS interventions according to safety guidelines
  • stable medication regime especially the classical neuroleptics and all CNS-activating medications, if taken, 4-6 weeks before the experiment
  • fluency in the native language
  • right-handed
  • ability to provide informed consent.

Exclusion Criteria:

  • pregnancy
  • alcohol or substance dependence
  • history of seizure
  • history of neurological disorder
  • history of head injury
  • Presence of ferromagnetic objects in the body that are contraindicated for MRI of the head (pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips, metallic prostheses, permanent eyeliner, implanted delivery pump, or shrapnel fragments) or fear of enclosed spaces). Eligibility will be determined by the "MRI Safety Screening Questionnaire" and verified, if necessary, by a radiology consultant.

Sites / Locations

  • The National Brain Mapping Laboratory (NBML)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active tDCS group

sham tDCS group

Arm Description

The experimental arm receives real (or active) electrical stimulation for 20 minutes

The sham arm receives sham (or no real) intervention in which stimulation lasts for 30 seconds and ends afterward.

Outcomes

Primary Outcome Measures

Working memory behavioral performance
A computerized version of 3- back letter task, optimized for administration in a functional MRI environment will be employed during the experiment
Modifications to blood-oxygen-level-dependent (BOLD) signal
Changes to blood-oxygen-level-dependent (BOLD) signal (arbitrary units) of brain areas that are implicated in cognitive impairment and pathophysiology of schizophrenia during the working memory task, as measured by fMRI following the intervention between the active and sham groups.

Secondary Outcome Measures

Full Information

First Posted
December 22, 2021
Last Updated
March 24, 2022
Sponsor
The National Brain Mapping Laboratory (NBML)
Collaborators
University of British Columbia, Ruhr University of Bochum, Leibniz Research Centre for Working Environment and Human Factors, University of Tehran
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1. Study Identification

Unique Protocol Identification Number
NCT05200962
Brief Title
Electrical Brain Stimulation for Cognitive Impairment in Schizophrenia: a tDCS-fMRI Study
Official Title
Investigating the Mechanism of Action of Electrical Brain Stimulation for Cognitive Impairment in Schizophrenia: a tDCS-fMRI Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
August 30, 2022 (Anticipated)
Study Completion Date
February 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The National Brain Mapping Laboratory (NBML)
Collaborators
University of British Columbia, Ruhr University of Bochum, Leibniz Research Centre for Working Environment and Human Factors, University of Tehran

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to investigate the mechanism of action of transcranial electrical brain stimulation over the dorsolateral prefrontal cortex for cognitive impairment in schizophrenia. To do so the effect of a novel stimulation protocol will be investigated in the fMRI scanner.
Detailed Description
Thirty schizophrenic patients will be recruited after meeting the inclusion criteria and will be randomly assigned to active and sham stimulation groups. A single session of concurrent prefrontal tDCS/fMRI will be conducted. Participants will undergo baseline task performance before the intervention. One week later, they will undergo the tDCS intervention (active or sham) in the scanner during which they perform the working memory task varying in cognitive load. They will perform the task 12 and 24 h later again.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Cognitive Impairment
Keywords
Schizophrenia, cognitive impairment, Transcranial direct current stimulation, fMRI

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active tDCS group
Arm Type
Experimental
Arm Description
The experimental arm receives real (or active) electrical stimulation for 20 minutes
Arm Title
sham tDCS group
Arm Type
Sham Comparator
Arm Description
The sham arm receives sham (or no real) intervention in which stimulation lasts for 30 seconds and ends afterward.
Intervention Type
Device
Intervention Name(s)
transcranial direct current stimulation
Other Intervention Name(s)
tDCS, tES
Intervention Description
In tDCS, direct electrical currents are generated by an electrical stimulator and are noninvasively delivered to the scalp through a pair of saline-soaked sponge electrodes (7×5 cm).
Primary Outcome Measure Information:
Title
Working memory behavioral performance
Description
A computerized version of 3- back letter task, optimized for administration in a functional MRI environment will be employed during the experiment
Time Frame
up to 24 hours after the intervention
Title
Modifications to blood-oxygen-level-dependent (BOLD) signal
Description
Changes to blood-oxygen-level-dependent (BOLD) signal (arbitrary units) of brain areas that are implicated in cognitive impairment and pathophysiology of schizophrenia during the working memory task, as measured by fMRI following the intervention between the active and sham groups.
Time Frame
up to 1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: men or women (18-50 yrs old) with a DSM 5 SCZ diagnosis, If female, negative urine pregnancy test significant cognitive impairment (1 SD below the norm on the working memory/executive functioning task performance) feasibility for tDCS interventions according to safety guidelines stable medication regime especially the classical neuroleptics and all CNS-activating medications, if taken, 4-6 weeks before the experiment fluency in the native language right-handed ability to provide informed consent. Exclusion Criteria: pregnancy alcohol or substance dependence history of seizure history of neurological disorder history of head injury Presence of ferromagnetic objects in the body that are contraindicated for MRI of the head (pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips, metallic prostheses, permanent eyeliner, implanted delivery pump, or shrapnel fragments) or fear of enclosed spaces). Eligibility will be determined by the "MRI Safety Screening Questionnaire" and verified, if necessary, by a radiology consultant.
Facility Information:
Facility Name
The National Brain Mapping Laboratory (NBML)
City
Tehran
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammad Ali Salehinejad, PhD
Phone
+4917642062686
Email
salehinejadmohammadali@gmail.com
First Name & Middle Initial & Last Name & Degree
Mohammad Ali Salehinejad, PhD
First Name & Middle Initial & Last Name & Degree
Amir-Homayun Hallajian, MSc

12. IPD Sharing Statement

Plan to Share IPD
No

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Electrical Brain Stimulation for Cognitive Impairment in Schizophrenia: a tDCS-fMRI Study

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