Multi-target brain stimulation for negative symptoms of schizophrenia

Development of a Multi-target Transcranial Magnetic Intervention Technique for Negative Symptoms of Schizophrenia

This trial will test whether multi-target TMS can reduce negative symptoms in people with first-episode schizophrenia.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 64 (estimated)
• Ages: 16 Years to 45 Years
• Sex: All
• Sponsor: Shanghai Mental Health Center (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07559084 on ClinicalTrials.gov

What this trial studies

This randomized controlled study applies a multi-target repetitive transcranial magnetic stimulation (rTMS) protocol aimed at the left dorsolateral prefrontal cortex, left inferior parietal lobule, and right orbitofrontal cortex to treat negative symptoms. MRI-guided neuronavigation will localize targets for each participant and theta burst stimulation (iTBS and cTBS) will be delivered at 100% of resting motor threshold. The protocol delivers 600 pulses per target (1800 pulses total) across repeated sessions, with a planned total of up to 50 TBS sessions and multiple sessions per day. Participants are randomized and must be 16–45 years old with first-episode schizophrenia on stable medication and significant negative symptoms on the PANSS-N scale.

Who should consider this trial

Good fit: Ideal candidates are people aged 16–45 with first-episode schizophrenia (duration <5 years), on a stable medication regimen, and with significant negative symptoms (PANSS-N > 15).

Not a fit: Patients with comorbid or lifetime psychiatric disorders, severe or unstable physical or neurological illnesses, or unstable medication regimens are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, this approach could lessen negative symptoms like social withdrawal and lack of motivation, improving daily functioning and quality of life.

How similar studies have performed: Previous single-target rTMS/TBS studies have shown modest and mixed benefits for negative symptoms (overall low/Level C evidence), while multi-target protocols of this kind are novel.

Eligibility criteria

Inclusion Criteria:

1. Outpatients or inpatients at the Department of Psychiatry, Shanghai Mental Health Center;
2. 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;
3. Male or female aged 16-45 years;
4. Education duration ≥ 9 years;
5. 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;
6. Participants and their guardians can understand and sign written informed consent;
7. Total score on the PANSS Negative Symptom subscale (PANSS-N) \> 15, and at least one item score ≥ 3.

Exclusion Criteria:

1. Current or lifetime psychiatric disorders as determined by SCID-5 assessment;
2. 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;
3. 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;
4. Pregnant or breastfeeding women;
5. Intellectual disability (IQ \< 70).

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai Mental Health Center — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Huiru Cui, Ph.D

Conditions SCHIZOPHRENIA 1; schizophrenia; TMS; repetitive transcranial magnetic stimulation; rTMS; TBS