Abstract：
BACKGROUND: Post-traumatic stress disorder (PTSD) is a prevalent and severe psychiatric disorder. Repetitive transcranial magnetic stimulation (rTMS) targeting the dorsolateral prefrontal cortex provides limited relief for symptoms of PTSD. This study will be conducted to validate the efficacy of MRI-guided rTMS in targeting the sites most closely associated with the amygdala for patients with PTSD. We hypothesise that the intervention will improve clinical symptoms by decreasing amygdala activity in patients.
METHODS: A randomised, double-blind, sham-controlled trial will be conducted. Forty-eight eligible patients with PTSD will be randomly assigned to receive either active or sham MRI-guided rTMS for 10 consecutive days after the initial MRI scans. MRI scans will be recollected at the end of the intervention. Clinical assessments will be performed at baseline, treatment day 5, treatment day 10, and 2 weeks, 4 weeks, 8 weeks after completion of the intervention to monitor changes in clinical symptoms. The primary assessment outcome is the change in PTSD symptoms between baseline and treatment day 10, as measured by the PTSD Checklist for DSM-5. Repeated measures analysis of variance will be performed using statistical software SPSS V.26.0. The significance level will be set at 0.05.
BACKGROUND: Ethical approval has been obtained from the Ethics Committee of Xijing Hospital in Xi\'an, China (KY20222176-X-1), and the trial has been registered on ClinicalTrials.gov. The findings of this trial will be disseminated at academic conferences or published in peer-reviewed scientific journals.
BACKGROUND: NCT05544110.
METHODS: A randomised, double-blind, sham-controlled trial will be conducted. Forty-eight eligible patients with PTSD will be randomly assigned to receive either active or sham MRI-guided rTMS for 10 consecutive days after the initial MRI scans. MRI scans will be recollected at the end of the intervention. Clinical assessments will be performed at baseline, treatment day 5, treatment day 10, and 2 weeks, 4 weeks, 8 weeks after completion of the intervention to monitor changes in clinical symptoms. The primary assessment outcome is the change in PTSD symptoms between baseline and treatment day 10, as measured by the PTSD Checklist for DSM-5. Repeated measures analysis of variance will be performed using statistical software SPSS V.26.0. The significance level will be set at 0.05.
BACKGROUND: Ethical approval has been obtained from the Ethics Committee of Xijing Hospital in Xi\'an, China (KY20222176-X-1), and the trial has been registered on ClinicalTrials.gov. The findings of this trial will be disseminated at academic conferences or published in peer-reviewed scientific journals.
BACKGROUND: NCT05544110.
摘要：
背景：创伤后应激障碍（PTSD）是一种普遍且严重的精神疾病。针对背外侧前额叶皮层的重复经颅磁刺激（rTMS）对PTSD症状的缓解有限。这项研究将用于验证MRI引导的rTMS在靶向PTSD患者与杏仁核最密切相关的部位方面的功效。我们假设干预将通过降低患者的杏仁核活性来改善临床症状。
方法：随机，双盲,将进行假对照试验.48名符合条件的PTSD患者将被随机分配在初始MRI扫描后连续10天接受主动或假MRI引导的rTMS。MRI扫描将在干预结束时重新收集。临床评估将在基线进行，治疗第5天，治疗第10天和2周，4周,8周后完成干预监测临床症状的变化。主要评估结果是基线和治疗第10天之间PTSD症状的变化，如DSM-5的PTSD清单所测量的。重复测量方差分析将使用统计软件SPSSV.26.0进行。显著性水平将设定为0.05。
背景：已获得西安市西京医院伦理委员会的伦理批准，中国(KY20222176-X-1),审判已在ClinicalTrials.gov上注册。该试验的结果将在学术会议上传播或在同行评审的科学期刊上发表。
背景：NCT05544110。
方法：随机，双盲,将进行假对照试验.48名符合条件的PTSD患者将被随机分配在初始MRI扫描后连续10天接受主动或假MRI引导的rTMS。MRI扫描将在干预结束时重新收集。临床评估将在基线进行，治疗第5天，治疗第10天和2周，4周,8周后完成干预监测临床症状的变化。主要评估结果是基线和治疗第10天之间PTSD症状的变化，如DSM-5的PTSD清单所测量的。重复测量方差分析将使用统计软件SPSSV.26.0进行。显著性水平将设定为0.05。
背景：已获得西安市西京医院伦理委员会的伦理批准，中国(KY20222176-X-1),审判已在ClinicalTrials.gov上注册。该试验的结果将在学术会议上传播或在同行评审的科学期刊上发表。
背景：NCT05544110。
