Personalized brain-guided iTBS for schizophrenia in routine clinics
Official title: Efficacy of Personalized iTBS in Real-World Clinical Settings for Alleviating Schizophrenia Symptoms : A Randomized Single-Blind Trial
Run by Anhui Medical University · NCT07176468 · Data updated 2026-11-12
This project will test whether personalized, neuronavigation-guided intermittent theta-burst stimulation (iTBS) can help reduce symptoms in adults with schizophrenia treated in routine clinical settings.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Anhui Medical University Academic / other |
| Locations | 2 sites (Hefei, Anhui and 1 other locations) |
| Status | Recruiting |
| Started | October 20, 2025 |
| Main results expected | September 20, 2026 |
| Study ends | September 20, 2026 |
| Registry record updated | December 30, 2025 |
| Trial ID | NCT07176468 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–60 with DSM-5 schizophrenia who can consent, have had any antipsychotic medication change within the past three days, and have no contraindications to MRI or TMS are ideal candidates.
✕Probably not a fit
Patients with active suicidal behavior, major neurological disorders, recent TMS/ECT within six months, pregnancy or incompatible implants (or other contraindications to MRI/TMS) are unlikely to benefit or to be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This open clinical intervention delivers individualized iTBS targets guided by each patient’s structural and resting-state fMRI and is given daily for two weeks in outpatient clinical settings. Baseline and post-treatment clinical ratings (PANSS, HAMA, HAMD and AHRS when applicable) and a battery of neuropsychological tests (MoCA, DST, VFT, Stroop, AVLT) are collected to measure change. Resting-state fMRI is used to identify personalized stimulation targets and to examine neural circuit changes after treatment. The protocol permits concurrent pharmacotherapy to reflect real-world care while monitoring adverse events and clinical outcomes.
Why it matters
Potential benefit: If successful, this approach could speed symptom improvement and offer a targeted, noninvasive treatment that can be added to routine medication regimens.
How similar studies have gone: Prior TMS and iTBS studies in schizophrenia have shown mixed but sometimes promising symptom improvements, while neuronavigation-guided, individualized targeting in real-world clinical settings remains relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Anhui Medical University
Hefei, Anhui, China Recruiting -
Anhui Medical University
Hefei, Anhui, China Not yet recruiting
Study contacts
- Study coordinator: Kai Wang, MD
- Email: wangkai1964@126.com
- Phone: 0551 6516 7581
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.