Transcranial Direct and Alternating Stimulation of the Prefrontal Cortex for Cognitive Improvement in Schizophrenia

The National Brain Mapping Laboratory (NBML)

Status and phase: Completed; Phase 1

Conditions: Schizophrenia; Cognitive Dysfunction

Treatments: Device: transcranial alternating current stimulation (tACS); Device: transcranial direct current stimulation (tDCS)

Study type: Interventional

Funder types: Other

Identifiers

NCT05342727

IR.ARUMS.REC.1400.043

Details and patient eligibility

About

The purpose of this study is to investigate different stimulation intensities and frequencies of transcranial direct and alternating current stimulation over the dorsolateral prefrontal cortex for cognitive improvement in schizophrenia.

Full description

In this randomized, double-blind study, 50 patients diagnosed with schizophrenia are randomly assigned into two arms. The first group receives transcranial direct current stimulation (tDCS) at three intensities (2 mA, 3 mA, and sham) and the second group receives transcranial alternating current stimulation (tACS) at three different frequencies (8 Hz, 40 Hz, and sham) over the left dorsolateral prefrontal cortex for 20 min. There are at least 72 hours between stimulation sessions. The patients conduct three cognitive tasks from the CANTAB neuropsychological battery for schizophrenia during stimulation including a working memory task, a cognitive flexibility task, and an emotion recognition task. Mood stability is also evaluated before and after each stimulation session with the Positive and Negative Affect Scale (PANAS).

Enrollment: 50 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of schizophrenia based on DSM V,
• Being 18-50 years old (male and female)
• If female, negative urine pregnancy test
• 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
• Required written informed consent signed by patients' guardian

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 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) or fear of enclosed spaces).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

50 participants in 2 patient groups

tDCS group

Active Comparator group

Description:

The tDCS arm receives two real (or active) stimulation at 2 mA and 3 mA intensities and one placebo electrical stimulation for 20 minutes.

Treatment:

Device: transcranial direct current stimulation (tDCS)

tACS group

Active Comparator group

Description:

The tACS arm receives two real (or active) stimulation at 8 Hz and 40 Hz frequencies and one placebo alternating electrical stimulation for 20 minutes.

Treatment:

Device: transcranial alternating current stimulation (tACS)