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: a Pilot Study

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

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sir Run Run Shaw Hospital (other)
• Locations: 1 site (Hanzhou, Zhejiang)
• Trial ID: NCT06231732 on ClinicalTrials.gov

What this trial studies

This pilot study investigates the effects of high-frequency transcranial alternating current stimulation (Hi-tACS) on cognitive impairment in patients diagnosed with schizophrenia. It employs a double-blind, randomized, controlled design to compare the effects of active Hi-tACS against a sham treatment. The study aims to address the significant cognitive deficits experienced by individuals with schizophrenia, which are often resistant to conventional pharmacological treatments. Participants will be clinically stable and receiving a stable dose of antipsychotic medication, ensuring a controlled environment for assessing the intervention's efficacy.

Who should consider this trial

Good fit: Ideal candidates for this study are 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 there have been studies exploring the effects of transcranial stimulation on cognitive function, the specific application of Hi-tACS in schizophrenia is relatively novel and has not been 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

• Zhejiang Tongde Hospital — Hanzhou, Zhejiang, China (RECRUITING)

Study contacts

• Study coordinator: Jinsong Tang, Doctorate

Conditions: Schizophrenia