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RecruitingNCT07176468

Personalized iTBS in Real-World Clinical Settings for Schizophrenia

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Trial Parameters

ConditionSchizophrenia
SponsorAnhui Medical University
Study TypeINTERVENTIONAL
PhaseN/A
Enrollment40
SexALL
Min Age18 Years
Max Age60 Years
Start Date2025-10-20
Completion2026-09-20
Interventions
Neuronavigation-guided individualized iTBS

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Brief Summary

This study is designed to determine whether neuronavigation-guided, personalized Intermittent Theta-Burst Stimulation (iTBS) can produce clinically benefits for patients with schizophrenia when delivered in real-world treatment settings. By situating the intervention within real-world treatment settings-without imposing restrictions on concurrent pharmacotherapy-this trial seeks to generate evidence that is both scientifically rigorous and clinically relevant. The main questions it seeks to address are: Does the personalized iTBS target TMS protocol improve clinical symptoms in patients with schizophrenia within real-world treatment settings? What neural circuit changes, as assessed by functional MRI, occur following TMS treatment? Participants will: Undergo personalized,personalized iTBS target treatment daily for 2 weeks. Complete baseline and post-treatment assessments, including clinical symptom scales (PANSS, HAMA, HAMD) and neuropsychological tests (MoCA, DST, VFT, Stroop Test, and AVLT). Have structural and resting-state functional MRI scans before and after treatment. Be monitored for any treatment-related adverse events.

Eligibility Criteria

Inclusion Criteria: * Aged 18-60 years, any gender * Meets DSM-5 criteria for schizophrenia * Antipsychotic medication change (initiation, dose adjustment, or switch) occurred within the past 3 days * Capable of understanding the study and providing written informed consent Able to comply with study procedures and complete assessments Exclusion Criteria: * Active suicidal ideation or behavior * Major neurological disorders (e.g., epilepsy, organic brain lesions, severe head trauma) * Contraindications to MRI or TMS (e.g., metal implants, pacemakers) * Pregnancy or lactation * Receipt of TMS or ECT within the past 6 months * Judged by investigators to be unsuitable for participation

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