Actively Recruiting
Personalized iTBS in Real-World Clinical Settings for Schizophrenia
Led by Anhui Medical University · Updated on 2025-12-30
40
Participants Needed
2
Research Sites
47 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Personalized iTBS in Real-World Clinical Settings for Schizophrenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 60 years, any gender
- Diagnosed with schizophrenia according to DSM-5 criteria
- Changed antipsychotic medication (start, dose change, or switch) within the past 3 days
- Able to understand the study and provide written informed consent
- Able to follow study procedures and complete assessments
You will not qualify if you...
- Active suicidal thoughts or behaviors
- Major neurological disorders such as epilepsy, organic brain lesions, or severe head trauma
- Contraindications to MRI or TMS, including metal implants or pacemakers
- Pregnancy or breastfeeding
- Received TMS or ECT treatments within the past 6 months
- Considered unsuitable for participation by the study investigators
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Anhui Medical University
Hefei, Anhui, China, 230000
Actively Recruiting
2
Anhui Medical University
Hefei, Anhui, China, 230032
Not Yet Recruiting
Research Team
K
Kai Wang, MD
CONTACT
G
Gong-Jun Ji, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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