Background

Innovative therapeutic interventions for post-traumatic stress disorder (PTSD) are required. We opted to facilitate fear extinction by combining trauma script exposure with repetitive transcranial magnetic stimulation (rTMS) to reduce symptoms of PTSD.

Objective

The efficacy and safety of 10 Hz rTMS of the right dorsolateral prefrontal cortex simultaneously with exposure to personal traumatic narrative were studied in patients with PTSD.

Materials and Methods

This trial was a single-center randomized controlled trial (NCT02584894). Patients were randomly assigned 1:1 to receive eight daily sessions of 110% of motor threshold high frequency (HF) 10 Hz rTMS (110% HF rTMS) or 70% low frequency (LF) 1 Hz rTMS (70% LF rTMS) with trauma script exposure in both groups. Severity of PTSD, depression, and anxiety were assessed before and after study treatment (one month, three months) by an assessor masked to the trial group assignment. The primary outcome was the severity of PTSD assessed by the Clinician Administered PTSD Scale (CAPS). We used mixed linear regression models for statistical comparisons.

Results

Thirty-eight patients (65.8% females) were randomly assigned to 110% HF rTMS (n = 18, 31.3 ± 10.0 years, 13 females) or 70% LF rTMS (n = 20, 33.5 ± 11.1 years, 12 females). From baseline to three months, mean CAPS scores decreased by 51% in the 110% HF rTMS group (from 83.7 ± 14.4 to 41.8 ± 31.9) and by 36.9% in the 70% LF rTMS group (from 81.8 ± 15.6 to 51.6 ± 23.7), but with no significant difference in improvement (time by treatment interaction −3.61 [95% confidence interval (CI), −9.70 to 2.47]; p = 0.24; effect size 0.53). One serious adverse event occurred during the study (psychogenic nonepileptic seizure).

Conclusion

We found no evidence of difference in clinical improvement or remission rates between the 110% HF and 70% LF stimulation. These findings may reflect the importance of exposure procedure and that larger number of participants is needed.

中文翻译：

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将创伤脚本暴露与 rTMS 相结合以减少创伤后应激障碍的症状：随机对照试验

背景

需要对创伤后应激障碍 (PTSD) 进行创新的治疗干预。我们选择通过将创伤脚本暴露与重复经颅磁刺激 (rTMS) 相结合来促进恐惧消退，以减轻 PTSD 的症状。

客观的

在 PTSD 患者中研究了 10 Hz rTMS 右侧背外侧前额叶皮层同时暴露于个人创伤性叙述的有效性和安全性。

材料和方法

该试验是一项单中心随机对照试验（NCT02584894）。患者被随机分配 1:1 每天接受 8 次 110% 运动阈值高频 (HF) 10 Hz rTMS (110% HF rTMS) 或 70% 低频 (LF) 1 Hz rTMS (70% LF rTMS)两组的创伤脚本暴露。在研究治疗之前和之后（1 个月、3 个月），PTSD、抑郁和焦虑的严重程度由一名对试验组分配不知情的评估员进行评估。主要结果是由临床医生管理的 PTSD 量表 (CAPS) 评估的 PTSD 的严重程度。我们使用混合线性回归模型进行统计比较。

结果

38 名患者（65.8% 女性）被随机分配到 110% HF rTMS（n  = 18, 31.3 ± 10.0 岁，13 名女性）或 70% LF rTMS（n  = 20, 33.5 ± 11.1 岁，12 名女性）。从基线到三个月，110% HF rTMS 组的平均 CAPS 分数下降了 51%（从 83.7 ± 14.4 到 41.8 ± 31.9），在 70% LF rTMS 组中下降了 36.9%（从 81.8 ± 15.6 到 51.6 ± 23.7 )，但在改善方面没有显着差异（治疗相互作用的时间 -3.61 [95% 置信区间 (CI)，-9.70 至 2.47]；p  = 0.24；效应大小 0.53）。研究期间发生了一起严重的不良事件（心因性非癫痫发作）。

结论

我们没有发现 110% HF 和 70% LF 刺激之间临床改善或缓解率存在差异的证据。这些发现可能反映了暴露程序的重要性以及需要更多的参与者。