RecruitingNot ApplicableNCT07176468

Personalized iTBS in Real-World Clinical Settings for Schizophrenia

Efficacy of Personalized iTBS in Real-World Clinical Settings for Alleviating Schizophrenia Symptoms : A Randomized Single-Blind Trial

Sponsor

Anhui Medical University

Enrollment

40 participants

Start Date

Oct 20, 2025

Study Type

INTERVENTIONAL

Conditions

Schizophrenia Transcranial Magnetic Stimulation

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

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether personalized brain stimulation — called intermittent theta burst stimulation (iTBS), a type of non-invasive repetitive transcranial magnetic stimulation (rTMS) — can improve symptoms in people with schizophrenia who have recently had their antipsychotic medication changed. **You may be eligible if...** - You are between 18 and 60 years old - You have a confirmed DSM-5 diagnosis of schizophrenia - Your antipsychotic medication was recently started, adjusted, or switched within the last 3 days - You can understand the study and provide written informed consent **You may NOT be eligible if...** - You have active thoughts of harming yourself - You have a major neurological disorder such as epilepsy or a history of severe head injury - You have metal implants, a pacemaker, or other contraindications to MRI or brain stimulation (TMS) - You are pregnant or breastfeeding - You have already received TMS treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERNeuronavigation-guided individualized iTBS

Participants will receive individualized iTBS for 14 consecutive days in addition to their usual medication regimen. iTBS parameters: 50 Hz bursts every 200 ms (5 Hz), 2s on/8s off, total 600 pulses per session;6 sessions/day (3 in morning, 3 in afternoon, 3600 pulses/day); 100% RMT intensity; Neuronavigation: Brainsight system (Rogue Research, Canada)