Personalized iTBS in Real-World Clinical Settings for Schizophrenia
EPSREAL-SC
Efficacy of Personalized iTBS in Real-World Clinical Settings for Alleviating Schizophrenia Symptoms : A Randomized Single-Blind Trial
1 other identifier
interventional
40
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable schizophrenia
Started Oct 2025
Shorter than P25 for not_applicable schizophrenia
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 9, 2025
CompletedFirst Posted
Study publicly available on registry
September 16, 2025
CompletedStudy Start
First participant enrolled
October 20, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 20, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 20, 2026
December 30, 2025
December 1, 2025
11 months
September 9, 2025
December 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Positive and Negative Syndrome Scale (PANSS)
The primary outcome was the changes in the Positive and Negative Syndrome Scale (PANSS) total scores from baseline to week 2. PANSS total score range 30 to 210, the higher scores indicate more severe symptoms.
baseline and week 2 (post-treatment)
Secondary Outcomes (4)
Positive and Negative Syndrome Scale (PANSS) subscales
baseline and week 2 (post-treatment)
Hamilton Anxiety Rating Scale (HAMA)
baseline and week 2 (post-treatment)
Hamilton Depression Rating Scale (HAMD)
baseline and week 2 (post-treatment)
Auditory Hallucination Rating Scale (AHRS)
baseline and week 2 (post-treatment)
Study Arms (2)
Experimental:Neuronavigation-guided individualized intermittent theta burst stimulation (iTBS)
EXPERIMENTALParticipants will receive iTBS daily for 2 week within real-world treatment settings
Control group: ordinary drug treatment
NO INTERVENTIONThe participants will receive regular medication treatment every day for 2 week.
Interventions
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)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Anhui Medical University
Hefei, Anhui, 230000, China
Anhui Medical University
Hefei, Anhui, 230032, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of the Department, Department of Neurology, The First Affiliated Hospital of Anhui Medical University
Study Record Dates
First Submitted
September 9, 2025
First Posted
September 16, 2025
Study Start
October 20, 2025
Primary Completion (Estimated)
September 20, 2026
Study Completion (Estimated)
September 20, 2026
Last Updated
December 30, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share