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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05200962
Other study ID # 2021_01_GF16
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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