Cognitive Effects of tDCS and tRNS in Schizophrenia

The National Brain Mapping Laboratory (NBML)

Status: Completed

Conditions: Cognitive Impairment; Schizophrenia

Treatments: Device: transcranial direct current stimulation (tDCS) sham stimulator; Device: transcranial random noise stimulation (tRNS); Device: transcranial direct current stimulation (tDCS) active stimulator

Study type: Interventional

Funder types: Other

Identifiers

NCT06155786

ifado-PNU

Details and patient eligibility

About

The purpose of this study is to investigate the cognitive effects of different electrical stimulation modalities, such as transcranial direct and random-noise stimulation over the dorsolateral prefrontal cortex, in schizophrenia.

Enrollment: 36 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of schizophrenia based on Diagnostic and Statistical Manual (DSM)5
• Being 18-50 years old (male and female)
• If female, negative urine pregnancy test
• feasibility for tDCS/tRNS interventions according to safety guidelines
• stable medication regime, especially for classical neuroleptics and all central nervous system activating medications, if taken, 4-6 weeks before the experiment
• fluency in the native language
• right-handed
• Required written informed consent signed by patients' guardian

Exclusion criteria

• pregnancy
• alcohol or substance dependence
• comorbid bipolar disorder and mood disorder
• history of seizure
• history of neurological disorder
• history of head injury
• Presence of ferromagnetic objects in the body that are contraindicated for brain stimulation 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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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36 participants in 3 patient groups

tDCS group

Active Comparator group

Description:

In tDCS, direct electrical currents at the intensity of 2 mA are generated by an electrical stimulator and are noninvasively delivered to the left and right dorsolateral prefrontal cortex through a pair of saline-soaked sponge electrodes (7×5 cm) for 30 minutes.

Treatment:

Device: transcranial direct current stimulation (tDCS) active stimulator

tRNS group

Active Comparator group

Description:

In tRNS, direct electrical currents at the intensity of 2 mA amplitude (offset at 1 mA) and frequency of 100-640 Hz are generated by an electrical stimulator and are noninvasively delivered to the left and right dorsolateral prefrontal cortex through a pair of saline-soaked sponge electrodes (7×5 cm) for 30 minutes.

Treatment:

Device: transcranial random noise stimulation (tRNS)

sham group

Sham Comparator group

Description:

In sham group, placebo stimulation is generated by an electrical stimulator and is noninvasively delivered to the left and right dorsolateral prefrontal cortex through a pair of saline-soaked sponge electrodes (7×5 cm) for 30 minutes.

Treatment:

Device: transcranial direct current stimulation (tDCS) sham stimulator