Efficacy of Hi-tACS for Schizophrenia Negative Symptoms

Launched by SHANGHAI MENTAL HEALTH CENTER · Mar 16, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Hi-tACS (high-frequency transcranial alternating current stimulation) to see if it can help improve negative symptoms in people with schizophrenia. Negative symptoms can include things like lack of motivation, social withdrawal, and difficulty experiencing pleasure. The trial will involve treating patients for two weeks and then assessing their progress in areas like cognitive functioning, social skills, and overall quality of life at the start, two weeks later, and three months after the treatment.

To participate in this study, individuals must be at least 18 years old, have been diagnosed with schizophrenia, and have specific negative symptoms as measured by a standard assessment. They also need to be able to fill out questionnaires on their own and not have other serious mental or physical health issues. Participants will receive either the Hi-tACS treatment or a control treatment and will be closely monitored throughout the study. This trial is currently recruiting participants, and it’s important that those interested sign an informed consent form to confirm they understand and agree to be part of the study.

Gender

ALL

Eligibility criteria

• 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 a total score of ≥24 on the PANSS negative subscales (N1-N7) and a score of ≥4 on at least 2 core symptoms (N1, N4, and N6);
• • 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) or score ≥4 on at least 2 core symptoms (P1, P3, P5, P6);
• • 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.

Trial Officials