RecruitingNot ApplicableNCT06888726

Efficacy of Hi-tACS for Schizophrenia Negative Symptoms

Efficacy of High-Intensity Transcranial Alternating Current Stimulation (Hi-tACS) in Treating Negative Symptoms of Schizophrenia


Sponsor

Shanghai Mental Health Center

Enrollment

60 participants

Start Date

Jun 27, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to investigate whether Hi-tACS is effective and safe in treating negative symptoms of schizophrenia. Schizophrenic patients will receive treatment (Hi-tACS or shame stimulation) for 2 weeks. Negative symptoms, cognitive functioning, social functioning, and quality of life of intervention group and control group were assessed and compared between the two groups at baseline, 2 weeks, and 3 months post-intervention.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a brain stimulation technique called Hi-tACS (high-intensity transcranial alternating current stimulation) — a non-invasive method using mild electrical currents applied to the scalp — to reduce "negative symptoms" of schizophrenia. Negative symptoms include things like reduced motivation, flat emotions, and social withdrawal, which are hard to treat with medications. **You may be eligible if...** - You are 18 or older and of Han Chinese ethnicity - You have a confirmed diagnosis of schizophrenia - You have residual negative symptoms despite medication - You have been on stable antipsychotic medication with no dose changes recently - You completed at least 6 years of schooling and can fill out questionnaires independently **You may NOT be eligible if...** - You have a history of seizures or epilepsy - You have metal implants in your head or a pacemaker - Your medications have changed recently - You have other major psychiatric or neurological conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEHigh-intensity transcranial alternating current stimulation (Hi-tACS)

The equipment used is the transcranial microcurrent stimulator (Nexalin ADI), operated by trained therapists following standardized instructions. Three Nexalin conductive electrodes are placed on the patient's head. A 4.45×9.53 cm electrode is placed on the forehead, corresponding to the Fpz region of the 10/20 international standard electrode placement system. Two 3.18×3.81 cm electrodes are placed on the bilateral dorsolateral prefrontal cortex, corresponding to the F3 and F4 regions of the international standard electrode placement system. The stimulation frequency is 77.5 Hz, and the current intensity is 15 mA.

DEVICESham High-intensity transcranial alternating current stimulation (Sham-Hi-tACS)

A sham device looks exactly the same as Nexalin ADI is used.


Locations(1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

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NCT06888726


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