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Search / Trial NCT06231732

The Hi-tACS on Cognitive Function in Patients With Schizophrenia: a Pilot Study

Launched by SIR RUN RUN SHAW HOSPITAL · Jan 20, 2024

Trial Information

Current as of July 03, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial, titled "The Hi-tACS on Cognitive Function in Patients With Schizophrenia: a Pilot Study," is looking at whether a special type of brain stimulation called high-frequency transcranial alternating current stimulation (Hi-tACS) can help improve thinking and memory problems in people with schizophrenia. The study is currently recruiting participants who are at least 18 years old, right-handed, and have a stable diagnosis of schizophrenia. To join, participants must be stable on their antipsychotic medications for at least four weeks and have a certain level of cognitive function, as measured by a simple test.

If someone is eligible and chooses to participate, they will be part of a randomized group where they may receive the Hi-tACS treatment or a placebo (a treatment that looks the same but has no active effect). This study is designed to be safe, and participants will be carefully monitored throughout the process. It's important to note that certain individuals, such as those with specific medical conditions or other mental health disorders, cannot participate to ensure their safety and the integrity of the study. If you or someone you know is interested in this trial, it could be a unique opportunity to contribute to understanding treatments for cognitive challenges in schizophrenia.

Gender

ALL

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.

About Sir Run Run Shaw Hospital

Sir Run Run Shaw Hospital is a distinguished medical institution dedicated to advancing healthcare through innovative clinical research and high-quality patient care. As a leading sponsor of clinical trials, the hospital integrates state-of-the-art medical technology with a commitment to ethical standards and patient safety. With a multidisciplinary team of experienced healthcare professionals, Sir Run Run Shaw Hospital focuses on a wide range of therapeutic areas, aiming to contribute to medical knowledge and improve treatment outcomes. The institution fosters collaboration with academic and industry partners to drive scientific discovery and enhance the quality of life for patients.

Locations

Hanzhou, Zhejiang, China

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported