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

Sponsor

The National Brain Mapping Laboratory (NBML) (Other)

Overall Status

Recruiting

CT.gov ID

NCT05200962

Collaborator

University of British Columbia (Other), Ruhr University of Bochum (Other), Leibniz Research Centre for Working Environment and Human Factors (Other), University of Tehran (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia Cognitive Impairment	Device: transcranial direct current stimulation	Phase 1

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

Investigating the Mechanism of Action of Electrical Brain Stimulation for Cognitive Impairment in Schizophrenia: a tDCS-fMRI Study

Actual Study Start Date :

Feb 1, 2022

Anticipated Primary Completion Date :

Aug 30, 2022

Anticipated Study Completion Date :

Feb 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active tDCS group The experimental arm receives real (or active) electrical stimulation for 20 minutes	Device: transcranial direct current stimulation 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). Other Names: tDCS tES
Sham Comparator: sham tDCS group The sham arm receives sham (or no real) intervention in which stimulation lasts for 30 seconds and ends afterward.	Device: transcranial direct current stimulation 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). Other Names: tDCS tES

Arm

Intervention/Treatment

Experimental: Active tDCS group

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

Device: transcranial direct current stimulation

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).

Other Names:

tDCS

tES

Sham Comparator: sham tDCS group

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

Device: transcranial direct current stimulation

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).

Other Names:

tDCS

tES

Outcome Measures

Primary Outcome Measures

Working memory behavioral performance [up to 24 hours after the intervention]
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 [up to 1 hour]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts 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.