Personalized iTBS in Real-World Clinical Settings for Schizophrenia

Recruiting · NCT07176468 · Interventional (participants receive a specific treatment) · Lead sponsor: Anhui Medical University

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Schizophrenia

Interventions studied

Neuronavigation-guided individualized iTBS

What this trial is about

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.

Who can take part

Age range

18 Years to 60 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

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 is running

2 locations listed.

Anhui Medical University - Hefei, Anhui, China
Anhui Medical University - Hefei, Anhui, China

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →