Status:
RECRUITING
Efficacy of Hi-tACS for Schizophrenia Negative Symptoms
Lead Sponsor:
Shanghai Mental Health Center
Conditions:
Schizophrenia; Negative Type
Transcranial Alternating Current Stimulation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Detailed Description
Objective: To investigate the therapeutic effects and short-term and long-term efficacy of high-intensity transcranial alternating current stimulation (Hi-tACS) on negative symptoms of schizophrenia. ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 27 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06888726
Start Date
June 27 2024
End Date
November 30 2026
Last Update
June 4 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China, 200030