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NCT07176468Recruiting

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

Source: ClinicalTrials.gov · Last updated 30 Dec 2025

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
40 (estimated)
First submitted
9 Sept 2025
Start date
20 Oct 2025
Primary completion date
20 Sept 2026
Lead sponsor
Anhui Medical University
NCT number
NCT07176468

What you commit to

  • Study type: Interventional
  • Planned participants: 40
  • From 20 Oct 2025 to the primary completion date, 20 Sept 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Contraindications to MRI or TMS (e.g., metal implants, pacemakers)

Other illness

  • Major neurological disorders (e.g., epilepsy, organic brain lesions, severe head trauma)

Other

  • Active suicidal ideation or behavior
  • Pregnancy or lactation
  • Receipt of TMS or ECT within the past 6 months
  • Judged by investigators to be unsuitable for participation

Who the study is looking for

  • 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

Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Anhui Medical University
Coordinator of this site? Confirm its status
HefeiChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.