Personalized iTBS in Real-World Clinical Settings for Schizophrenia
NCT ID: NCT07176468
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2025-10-20
2026-09-20
Brief Summary
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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.
Detailed Description
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Before treatment, structural and resting-state functional MRI data wil be collected from each patient. Clinical symptom severity will be assessed using the Positive and Negative Syndrome Scale (PANSS), Hamilton Anxiety Rating Scale (HAMA), and Hamilton Depression Rating Scale (HAMD). For patients experiencing auditory verbal hallucinations, the Auditory Hallucination Rating Scale (AHRS) will be also administered. Additionally, a battery of neuropsychological tests will be conducted, including the Montreal Cognitive Assessment (MoCA), Digit Span Test (DST), Verbal Fluency Test (VFT), Stroop Test, and Chinese Auditory Verbal Learning Test (AVLT).
After completing the 2-week iTBS treatment, clinical symptom severity, treatment-related adverse events wil be reassessed.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Experimental:Neuronavigation-guided individualized intermittent theta burst stimulation (iTBS)
Participants will receive iTBS daily for 2 week within real-world treatment settings
Neuronavigation-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)
Control group: ordinary drug treatment
The participants will receive regular medication treatment every day for 2 week.
No interventions assigned to this group
Interventions
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Neuronavigation-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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
No
Sponsors
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Anhui Medical University
OTHER
Responsible Party
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WANG KAI
Head of the Department, Department of Neurology, The First Affiliated Hospital of Anhui Medical University
Locations
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Anhui Medical University
Hefei, Anhui, China
Anhui Medical University
Hefei, Anhui, China
Countries
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Central Contacts
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Facility Contacts
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Gong-Jun Ji
Role: primary
Kai Wang, PhD
Role: primary
Gong-Jun, PhD
Role: backup
Other Identifiers
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AHMU-SCZ-RWTBS
Identifier Type: -
Identifier Source: org_study_id