Personalized iTBS in Real-World Clinical Settings for Schizophrenia

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorAnhui Medical University

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Neuronavigation-guided individualized iTBS

Treatment groups

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators