NCT07176468 Personalized iTBS in Real-World Clinical Settings for Schizophrenia
| NCT ID | NCT07176468 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Anhui Medical University |
| Condition | Schizophrenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-10-20 |
| Primary Completion | 2026-09-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2025-10-20 with a primary completion date of 2026-09-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07176468 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Schizophrenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07176468 currently recruiting?
Yes, NCT07176468 is actively recruiting participants. Contact the research team at wangkai1964@126.com for enrollment information.
Where is the NCT07176468 trial being conducted?
This trial is being conducted at Hefei, China, Hefei, China.
Who is sponsoring the NCT07176468 clinical trial?
NCT07176468 is sponsored by Anhui Medical University. The trial plans to enroll 40 participants.
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