Testing Hi-tACS for treating negative symptoms of schizophrenia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness and safety of high-intensity transcranial alternating current stimulation (Hi-tACS) in alleviating negative symptoms associated with schizophrenia. A total of 60 participants will be randomly assigned to receive either Hi-tACS or sham stimulation over a two-week period, with assessments conducted at baseline, after treatment, and three months later. The study will measure changes in negative symptoms, cognitive functioning, social functioning, and quality of life. Both groups will continue their regular medication regimen throughout the trial.

Why it matters

Who can join: the full rules

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.

Where it's running

• Shanghai Mental Health Center
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Qing Fan — Shanghai Mental Health Center
• Study coordinator: Qing Fan, Doctor
• Email: fanqing_98@vip.sina.com
• Phone: 18017311322

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.