Efficacy of Hi-tACS for Schizophrenia Negative Symptoms (NCT06888726) | Clinical Trial Compass
RecruitingNot Applicable
Efficacy of Hi-tACS for Schizophrenia Negative Symptoms
China60 participantsStarted 2024-06-27
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 preve…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in negative symptoms of schizophrenia
Timeframe: change between baseline (W0), the end of intervention at 2 weeks (W2) and 3 months after intervention (M3)