Multi-target TMS for Schizophrenia Negative Symptoms
Recruiting · NCT07559084 · Interventional (participants receive a specific treatment) · Lead sponsor: Shanghai Mental Health Center
View the official record on ClinicalTrials.gov →Interventions studied
repetitive transcranial magnetic stimulation (rTMS)
What this trial is about
This randomized controlled trial (RCT) is the first to evaluate the efficacy and safety of a multi-target TMS protocol targeting the left dorsolateral prefrontal cortex (L-DLPFC), left inferior parietal lobule (L-IPL), and right orbitofrontal cortex (R-OFC) for negative symptoms of schizophrenia.
Who can take part
Age range
16 Years to 45 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Outpatients or inpatients at the Department of Psychiatry, Shanghai Mental Health Center;
- Meet the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for first-episode schizophrenia (diagnosed using the Structured Clinical Interview for DSM-5, SCID-5); disease duration less than 5 years at enrollment;
- Male or female aged 16-45 years;
- Education duration ≥ 9 years;
- Stable medication regimen for at least 6 weeks prior to baseline visit and throughout the study period; psychiatric symptoms generally stable within 1 month prior to baseline visit;
- Participants and their guardians can understand and sign written informed consent;
- Total score on the PANSS Negative Symptom subscale (PANSS-N) \> 15, and at least one item score ≥ 3.
Exclusion criteria
- Current or lifetime psychiatric disorders as determined by SCID-5 assessment;
- Severe or unstable physical illnesses, including: neurological disorders (delirium, dementia, stroke, epilepsy, migraine, etc.), congestive heart failure, angina pectoris, myocardial infarction, arrhythmia, hypertension, hyperglycemia, malignant tumors, and immunocompromised conditions;
- Alcohol abuse within 30 days prior to the study or alcohol/drug dependence within 6 months prior to the study; participation in any clinical trial within 30 days prior to baseline;
- Pregnant or breastfeeding women;
- Intellectual disability (IQ \< 70).
Where it is running
1 location listed.
- Shanghai Mental Health Center - Shanghai, Shanghai Municipality, China