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RECRUITINGINTERVENTIONAL

Efficacy of Hi-tACS for Schizophrenia Negative Symptoms

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Han Chinese population; - Age ≥ 18 years; - Education level ≥ 6 years, able to fill out questionnaires on their own, and having sufficient audiovisual level to complete the necessary examinations; - Meets DSM-5 diagnostic criteria for schizophrenia as assessed by MINI 7.0; - Residual negative symptoms, with at least one item ≥2 on the negative subscale of PANSS (N1-N7); - Taking second-generation atypical antipsychotic medication, with no medication or dosage adjustments in the last two weeks - Patients and guardians agreed to participate in the study and signed an willing to sign a consent form form. Who Should NOT Join This Trial: - Meets DSM-5 diagnostic criteria for other mental disorders; - Total score ≥19 on the PANSS positive subscales (P1-P7) ; - Severe negative symptoms that prevent the patient from completing the required assessments and interventions; - Serious physical or central nervous system disease (intracranial infection, intracranial tumor, presence of metal objects in the skull; epilepsy, seizures; history of hydrocephalus or central nervous system tumors; with implanted electronic devices; serious cardiac disease and fitted with a pacemaker, etc.); - Impaired skin integrity at the site of electrode placement or hypersensitivity to electrode gels or adhesives; - Mental retardation (Wechsler Adult Intelligence Scale WAIS \<70) and/or severe cognitive impairment (Brief Mental State Examination MMSE \<24); - Presence of vision and/or hearing problems that prevent completion of relevant tests; - Alcohol or drug abuse/dependence; - Pregnancy; - Those who have participated or are participating in other clinical studies 3 months ago; - Failure or refusal to sign the willing to sign a consent form form. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Han Chinese population; * Age ≥ 18 years; * Education level ≥ 6 years, able to fill out questionnaires on their own, and having sufficient audiovisual level to complete the necessary examinations; * Meets DSM-5 diagnostic criteria for schizophrenia as assessed by MINI 7.0; * Residual negative symptoms, with at least one item ≥2 on the negative subscale of PANSS (N1-N7); * Taking second-generation atypical antipsychotic medication, with no medication or dosage adjustments in the last two weeks * Patients and guardians agreed to participate in the study and signed an informed consent form. Exclusion Criteria: * Meets DSM-5 diagnostic criteria for other mental disorders; * Total score ≥19 on the PANSS positive subscales (P1-P7) ; * Severe negative symptoms that prevent the patient from completing the required assessments and interventions; * Serious physical or central nervous system disease (intracranial infection, intracranial tumor, presence of metal objects in the skull; epilepsy, seizures; history of hydrocephalus or central nervous system tumors; with implanted electronic devices; serious cardiac disease and fitted with a pacemaker, etc.); * Impaired skin integrity at the site of electrode placement or hypersensitivity to electrode gels or adhesives; * Mental retardation (Wechsler Adult Intelligence Scale WAIS \<70) and/or severe cognitive impairment (Brief Mental State Examination MMSE \<24); * Presence of vision and/or hearing problems that prevent completion of relevant tests; * Alcohol or drug abuse/dependence; * Pregnancy; * Those who have participated or are participating in other clinical studies 3 months ago; * Failure or refusal to sign the informed consent form.

Treatments Being Tested

DEVICE

High-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.

DEVICE

Sham 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