Personalized iTBS in Real-World Clinical Settings for Schizophrenia (EPSREAL-SC)

Anhui Medical University

Status

Enrolling

Conditions

Schizophrenia

Transcranial Magnetic Stimulation

Treatments

Other: Neuronavigation-guided individualized iTBS

Study type

Interventional

Funder types

Other

Identifiers

NCT07176468

AHMU-SCZ-RWTBS

Details and patient eligibility

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.

Full description

Effective intervention is critical for reducing relapse risk, improving long-term prognosis, and lowering healthcare costs for schizophrenia.The present study therefore aims to assess whether neuronavigation-guided, individualized Intermittent Theta-Burst Stimulation (iTBS) can accelerate symptom improvement in schizophrenia when delivered in real-world clinical 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. Patients with schizophrenia will be prospectively recruited and received 2 weeks of iTBS treatment.

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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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