Personalized Repetitive Transcranial Magnetic Stimulation for Patients with Refractory Schizophrenia: an Open-label Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Positive And Negative Syndrome Scale (PANSS)
研究概览
简要总结
The goal of this clinical trial is to evaluate the efficacy of personalized dual-target rTMS for treating patients with refractory schizophrenia and to investigate its underlying neural mechanisms using functional MRI.
The main questions it seeks to address are:
Does the dual-target rTMS protocol improve clinical symptoms in patients with refractory schizophrenia? What neural circuit changes, as assessed by functional MRI, occur following rTMS treatment?
Participants will:
Undergo personalized, dual-target rTMS treatment daily for 3 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
This open-label clinical trial aimed to evaluate the efficacy and underlying neural mechanisms of a personalized dual-target rTMS protocol for treating patients with refractory schizophrenia. Patients with refractory schizophrenia were prospectively recruited and underwent 3 weeks of rTMS treatment.
Before treatment, structural and resting-state functional MRI data were collected from each patient. Clinical symptom severity was 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) was also administered. Additionally, a battery of neuropsychological tests was 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 3-week rTMS treatment, clinical symptom severity, treatment-related adverse events, and structural and resting-state functional MRI data were reassessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •diagnosed by independent psychiatrists using the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition;
- •disease duration longer than six years;
- •hospitalization two or more times;
- •aged 18-60 years;
- •a stable dosage of antipsychotic medication for at least four weeks before inclusion, and retention of this stable dose for the duration of the study.
排除标准
- •accompanied by other mental illnesses or histories;
- •a history of severe head trauma or neurological disease;
- •focal brain lesions on T1- or T2-weighted fluid-attenuated inversion-recovery MRI;
- •a history of rTMS or electroconvulsive therapy in the six months prior to the study; and
- •metal objects in the head or any other contraindication to MRI.
研究组 & 干预措施
Personalized dual-target active rTMS treatment
Active rTMS was sequentially administered over the left DLPFC and left TPJ sites one hour apart, for 3 weeks.
干预措施: Active rTMS was administered using a transcranial magnetic stimulator (Rapid2; MagStim). (Device)
结局指标
主要结局
Positive And Negative Syndrome Scale (PANSS)
时间窗: baseline and week 3 (post-treatment)
The primary outcome was the changes in the Positive and Negative Syndrome Scale (PANSS) total scores from baseline to week 3. 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 3 (post-treatment))
- Hamilton Anxiety Rating Scale (HAMA)(baseline and week 3 (post-treatment))
- Hamilton Depression Rating Scale (HAMD)(baseline and week 3 (post-treatment))
- Auditory Hallucination Rating Scale (AHRS)(baseline and week 3 (post-treatment))
研究者
WANG KAI
MD
Anhui Medical University