Efficacy of Hi-tACS for Schizophrenia Negative Symptoms
Efficacy of High-Intensity Transcranial Alternating Current Stimulation (Hi-tACS) in Treating Negative Symptoms of Schizophrenia
Shanghai Mental Health Center
60 participants
Jun 27, 2024
INTERVENTIONAL
Conditions
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 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.
Eligibility
Inclusion Criteria7
- 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 Criteria11
- 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.
Interventions
The equipment used is the transcranial microcurrent stimulator (Nexalin ADI), operated by trained therapists following standardized instructions. Three Nexalin conductive electrodes are placed on the patient's head. A 4.45×9.53 cm electrode is placed on the forehead, corresponding to the Fpz region of the 10/20 international standard electrode placement system. Two 3.18×3.81 cm electrodes are placed on the bilateral dorsolateral prefrontal cortex, corresponding to the F3 and F4 regions of the international standard electrode placement system. The stimulation frequency is 77.5 Hz, and the current intensity is 15 mA.
A sham device looks exactly the same as Nexalin ADI is used.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06888726