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

The Impact of High-frequency Transcranial Alternating Current Stimulation (Hi-tACS) on Cognitive Function in Patients With Schizophrenia

This study is testing whether a new brain stimulation technique can help improve thinking and memory skills in people with schizophrenia.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sir Run Run Shaw Hospital (other)
• Locations: 2 sites (Hanzhou, Zhejiang and 1 other locations)
• Trial ID: NCT06470516 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include right-handed adults aged 18 and older who have a diagnosis of schizophrenia and are clinically stable on antipsychotic medication.

Not a fit: Patients with psychotic disorders stemming from other conditions or those with severe organic diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved cognitive function in patients with schizophrenia, enhancing their quality of life.

How similar studies have performed: While some studies have shown promise with transcranial stimulation techniques, the specific application of Hi-tACS in this context is relatively novel and not extensively tested.

Eligibility criteria

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 this trial is running

Hanzhou, Zhejiang and 1 other locations

• Sir Run Run Shaw Hospital — Hanzhou, Zhejiang, China (RECRUITING)
• Quzhou Third Hospital — Quzhou, Zhejiang, China (RECRUITING)

Study contacts

• Study coordinator: Jinsong Tang, Doctorate

Conditions: Schizophrenia