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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05200962
• Other study ID #: 2021_01_GF16
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: February 1, 2022
• Est. completion date: August 1, 2024

Study information

• Verified date: November 2023
• Source: The National Brain Mapping Laboratory (NBML)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 3-mA stimulation protocol on neurocognitive functions will be investigated using behavioral performance and fMRI.

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) next to the scanner during which they perform the working memory task varying in cognitive load. They will perform the task 24 h later again. They will be then transferred to MRI scanner right after stimulation

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: August 1, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Schizophrenia

Intervention

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).

Locations

Country	Name	City	State
Iran, Islamic Republic of	The National Brain Mapping Laboratory (NBML)	Tehran

Sponsors (5)

Lead Sponsor	Collaborator
The National Brain Mapping Laboratory (NBML)	Leibniz Research Centre for Working Environment and Human Factors, Ruhr University of Bochum, University of British Columbia, University of Tehran

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	up to 24 hours after the intervention
Primary	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.	up to 1 hour