RecruitingNot ApplicableNCT07176468

Personalized iTBS in Real-World Clinical Settings for Schizophrenia

Efficacy of Personalized iTBS in Real-World Clinical Settings for Alleviating Schizophrenia Symptoms : A Randomized Single-Blind Trial


Sponsor

Anhui Medical University

Enrollment

40 participants

Start Date

Oct 20, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria4

  • 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 Criteria6

  • 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

Interventions

OTHERNeuronavigation-guided individualized iTBS

Participants will receive individualized iTBS for 14 consecutive days in addition to their usual medication regimen. iTBS parameters: 50 Hz bursts every 200 ms (5 Hz), 2s on/8s off, total 600 pulses per session;6 sessions/day (3 in morning, 3 in afternoon, 3600 pulses/day); 100% RMT intensity; Neuronavigation: Brainsight system (Rogue Research, Canada)


Locations(2)

Anhui Medical University

Hefei, Anhui, China

Anhui Medical University

Hefei, Anhui, China

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NCT07176468


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