Multi-target TMS for Schizophrenia Negative Symptoms

NCT07559084 | Recruiting

• 1 other identifier: IRB, SMHC, 2025-97
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

SCHIZOPHRENIA 1 (Disorder)

Keywords

schizophrenia; TMS; repetitive transcranial magnetic stimulation; rTMS; TBS

Outcome Measures

Primary Outcomes (1)

• Change in severity of negative symptoms before and after TBS intervention, i.e., change in Positive and Negative Syndrome Scale - Negative subscale (PANSS-N)

  Schizophrenia negative symptoms assessed using Positive and Negative Syndrome Scale - Negative subscale (PANSS-N) Minimum value: 7 (each of the 7 items scored 1 = absent) Maximum value: 49 (each of the 7 items scored 7 = extreme) Higher score indicates: Worse outcome (greater severity of negative symptoms)

  Negative symptoms will be measured at baseline (Day-4±2), immediately after the 50th session of TBS (Day 14), and at 1 week (Day 21), 2 weeks (Day 28), and 4 weeks ( Day 42) after completion of TBS treatment.

Secondary Outcomes (7)

• Change in cognitive function scores before and after intervention

  MATRICS Consensus Cognitive Battery (MCCB) will be measured at baseline (Day-4±2), immediately after the 50th session of TBS (Day 14), and 4 weeks ( Day 42) after completion of TBS treatment.

• Change in positive symptom scores before and after intervention

  Positive symptoms will be measured at baseline (Day-4±2), immediately after the 50th session of TBS (Day 14), and at 1 week (Day 21), 2 weeks (Day 28), and 4 weeks ( Day 42) after completion of TBS treatment.

• Change in general symptom scores before and after intervention

  General symptoms will be measured at baseline (Day-4±2), immediately after the 50th session of TBS (Day 14), and at 1 week (Day 21), 2 weeks (Day 28), and 4 weeks ( Day 42) after completion of TBS treatment.

• Change in anxiety symptoms before and after intervention

  Anxiety symptoms will be measured at baseline (Day-4±2), immediately after the 50th session of TBS (Day 14), and at 1 week (Day 21), 2 weeks (Day 28), and 4 weeks ( Day 42) after completion of TBS treatment.

• Depressive symptoms changes

  Depressive symptoms will be measured at baseline (Day-4±2), immediately after the 50th session of TBS (Day 14), and at 1 week (Day 21), 2 weeks (Day 28), and 4 weeks ( Day 42) after completion of TBS treatment.

Study Arms (2)

TBS intervention targeting multiple targets (L-DLPFC, L-IPL, R-OFC)

ACTIVE COMPARATOR

Device: repetitive transcranial magnetic stimulation (rTMS)

Control group

SHAM COMPARATOR

Same targets, same TBS parameters, coil rotated 180°

Device: repetitive transcranial magnetic stimulation (rTMS)

Interventions

repetitive transcranial magnetic stimulation (rTMS) DEVICE

Repetitive transcranial magnetic stimulation (rTMS) is a recently developed neuromodulation technique.

Control group; TBS intervention targeting multiple targets (L-DLPFC, L-IPL, R-OFC)

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Central Study Contacts

Huiru Cui, Ph.D

CONTACT

+86 21 34773230; cuihuiru@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 30, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): January 30, 2028
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)