Using high-frequency brain stimulation to improve cognitive function in schizophrenia patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This intervention explores the effects of high-frequency transcranial alternating current stimulation (Hi-tACS) on cognitive impairment in individuals diagnosed with schizophrenia. The study is designed as a double-blind, randomized, controlled trial, comparing the effects of active Hi-tACS against a sham treatment. Cognitive impairment is a significant issue for schizophrenia patients, and traditional pharmacological treatments often do not address these deficits effectively. By employing Hi-tACS, which uses higher electrical currents than conventional methods, the study aims to directly stimulate brain regions associated with cognitive functions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Meets the diagnostic criteria for schizophrenia according to DSM-5.
2. Age ≥ 18 years old.
3. Right-handed.
4. Willing to participate in this study and sign an informed consent form. If the participant is unable to read and sign the informed consent form due to lack of capacity, a legal guardian must act as a proxy during the informed consent process and sign the form.
5. Clinically stable, receiving antipsychotic medication treatment with a stable dose for 4 weeks without any changes.
6. Montreal Cognitive Assessment score ≥ 10 points.

Exclusion Criteria:

1. Psychotic disorders caused by split affective disorder, bipolar disorder, intellectual disability, anxiety spectrum disorders, drugs, alcohol, and other psychoactive substances according to DSM-V diagnostic criteria.
2. Those with severe or unstable organic diseases, with a history of brain tumors or epilepsy.
3. Those who have received MECT or TMS treatment within 1 month before enrollment.
4. Skin integrity at the electrode placement site is compromised. Allergy to electrode gel or adhesive.
5. Implants of metal or electronic devices (such as pacemakers, cochlear implants, deep brain stimulators, aneurysm clips, internal fixation devices after ventriculoperitoneal shunt surgery, etc.).
6. Participation in any other clinical trials within 1 month prior to baseline.
7. Pregnant and lactating women.
8. The investigator believes that there are inappropriate conditions for participating in this study.

Where it's running

• Sir Run Run Shaw Hospital
  Hanzhou, Zhejiang, China Recruiting
• Quzhou Third Hospital
  Quzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Jinsong Tang, Doctorate
• Email: tangjinsong@zju.edu.cn
• Phone: +8613627311963

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.