Efficacy of Hi-tACS for Schizophrenia Negative Symptoms
Recruiting · NCT06888726 · Interventional (participants receive a specific treatment) · Lead sponsor: Shanghai Mental Health Center
View the official record on ClinicalTrials.gov →Interventions studied
High-intensity transcranial alternating current stimulation (Hi-tACS)Sham High-intensity transcranial alternating current stimulation (Sham-Hi-tACS)
What this trial is about
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 can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed.
- Shanghai Mental Health Center - Shanghai, Shanghai Municipality, China