Efficacy of Personalized iTBS in Real-World Clinical Settings for Alleviating Schizophrenia Symptoms : A Randomized Single-Blind Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- The Positive and Negative Syndrome Scale (PANSS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Experimental:Neuronavigation-guided individualized intermittent theta burst stimulation (iTBS)
Participants will receive iTBS daily for 2 week within real-world treatment settings
干预措施: Neuronavigation-guided individualized iTBS (Other)
Control group: ordinary drug treatment
The participants will receive regular medication treatment every day for 2 week.
结局指标
主要结局
The Positive and Negative Syndrome Scale (PANSS)
时间窗: baseline and week 2 (post-treatment)
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.
The Positive and Negative Syndrome Scale (PANSS)
时间窗: baseline and week 2 (post-treatment)
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.
次要结局
- 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))
- Auditory Hallucination Rating Scale (AHRS)(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))
- Positive and Negative Syndrome Scale (PANSS) subscales(baseline and week 2 (post-treatment))
研究者
WANG KAI
Head of the Department, Department of Neurology, The First Affiliated Hospital of Anhui Medical University
Anhui Medical University