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

The National Brain Mapping Laboratory (NBML)

Status and phase

Active, not recruiting

Phase 1

Conditions

Cognitive Impairment

Schizophrenia

Treatments

Device: transcranial direct current stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT05200962

2021_01_GF16

Details and patient eligibility

About

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.

Full 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

Enrollment

30 estimated patients

Sex

All

Ages

18 to 50 years old

Volunteers

No 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.