Personalized brain-guided iTBS for schizophrenia in routine clinics
Efficacy of Personalized iTBS in Real-World Clinical Settings for Alleviating Schizophrenia Symptoms : A Randomized Single-Blind Trial
NA · Anhui Medical University · NCT07176468
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Anhui Medical University (other) |
| Locations | 2 sites (Hefei, Anhui and 1 other locations) |
| Trial ID | NCT07176468 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Hefei, Anhui and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Schizophrenia, Transcranial Magnetic Stimulation, schizophrenia, transcranial magnetic stimulation, Functional Magnetic Resonance Imaging