Testing Hi-tACS for treating negative symptoms of schizophrenia
Efficacy of High-Intensity Transcranial Alternating Current Stimulation (Hi-tACS) in Treating Negative Symptoms of Schizophrenia
This study is testing if a new brain stimulation treatment can help people with schizophrenia feel better by reducing negative symptoms like lack of motivation and social withdrawal.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shanghai Mental Health Center Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06888726 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness and safety of high-intensity transcranial alternating current stimulation (Hi-tACS) in alleviating negative symptoms associated with schizophrenia. A total of 60 participants will be randomly assigned to receive either Hi-tACS or sham stimulation over a two-week period, with assessments conducted at baseline, after treatment, and three months later. The study will measure changes in negative symptoms, cognitive functioning, social functioning, and quality of life. Both groups will continue their regular medication regimen throughout the trial.
Who should consider this trial
Good fit: Ideal candidates are Han Chinese adults aged 18 and older with schizophrenia and residual negative symptoms who are stable on their medication.
Not a fit: Patients with other mental disorders or severe positive symptoms of schizophrenia may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life and social functioning for patients suffering from negative symptoms of schizophrenia.
How similar studies have performed: While the use of transcranial stimulation techniques is gaining traction, the specific application of Hi-tACS for negative symptoms in schizophrenia is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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 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 this trial is running
Shanghai, Shanghai Municipality
- Shanghai Mental Health Center — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: Qing Fan — Shanghai Mental Health Center
- Study coordinator: Qing Fan, Doctor
- Email: fanqing_98@vip.sina.com
- Phone: 18017311322
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.