💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
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