Tests a brain stimulation device for negative symptoms of schizophrenia
Tests whether a brain stimulation device helps adults with schizophrenia negative symptoms.
Plain-language title generated from the registry record
Registry title: Efficacy of Hi-tACS for Schizophrenia Negative Symptoms
Key facts
- Where
- Shanghai, ChinaSee the site
Where in China
- Shanghai Mental Health CenterShanghai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Shanghai Mental Health Center
- Trial code
- NCT06888726
- Record updated
- 4 June 2025
- Original description
The goal of this clinical trial is to investigate whether Hi-tACS is effective and safe in treating negative symptoms of schizophrenia.Read full original descriptionShow less
Efficacy of High-Intensity Transcranial Alternating Current Stimulation (Hi-tACS) in Treating Negative Symptoms of Schizophrenia
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.
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: Alcohol or drug abuse/dependence; Meets DSM-5 diagnostic criteria for other mental disorders; 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); Failure or refusal to sign the informed consent form; Total score ≥19 on the PANSS positive subscales (P1-P7) ; Severe negative symptoms that prevent the patient from completing the required assessments and interventions; Presence of vision and/or hearing problems that prevent completion of relevant tests; Pregnancy; Those who have participated or are participating in other clinical studies 3 months ago.