Personalized iTBS in Real-World Clinical Settings for Schizophrenia
Recruiting now · Not applicable
Conditions studied: Schizophrenia, Transcranial Magnetic Stimulation
In brief
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.
Key facts
- Study ID
- NCT07176468
- Run by
- Anhui Medical University
- People needed
- 40
- Starts
- 2025-10-20
- Expected to finish
- 2026-09-20
- Last updated by the study team
- 2025-12-30
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Anhui Medical University — Hefei, Anhui, China (enrolling)
- Anhui Medical University — Hefei, Anhui, China
Full record on ClinicalTrials.gov
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