NCT06888726Recruiting
Efficacy of Hi-tACS for Schizophrenia Negative Symptoms
Efficacy of High-Intensity Transcranial Alternating Current Stimulation (Hi-tACS) in Treating Negative Symptoms of Schizophrenia
Source: ClinicalTrials.gov · Last updated 4 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 20 Feb 2025
- Start date
- 27 Jun 2024
- Primary completion date
- 30 Nov 2025
- Lead sponsor
- Shanghai Mental Health Center
- Diseases
- Schizophrenia
- NCT number
- NCT06888726
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 27 Jun 2024 to the primary completion date, 30 Nov 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Alcohol or drug abuse/dependence;
Other illness
- 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.
Other
- 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;
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Mental Health Center Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.