Safety Considerations for the Use of Transcranial Magnetic Stimulation as Treatment for Coma Recovery in People With Severe Traumatic Brain Injury.
Safety Considerations for the Use of Transcranial Magnetic Stimulation as Treatment for Coma Recovery in People With Severe Traumatic Brain Injury.
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DOI：
10.1097/htr.0000000000000636
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发表时间：
2020-11
期刊：
影响因子：
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通讯作者：
Bender Pape TL
中科院分区：
文献类型：
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作者：
Kletzel SL;Aaronson AL;Guernon A;Carbone C;Chaudhry N;Walsh E;Conneely M;Patil V;Roth E;Steiner M;Pacheco M;Rosenow J;Bender Pape TL
对于严重创伤性脑损伤（sTBI）后意识紊乱状态（DoC）的人，我们报告了2项不同研究中重复性经颅磁刺激（rTMS）参数方案的累积安全性检查结果，包括严重不良事件（ae）。7人在sTBI后出现DoC状态，伴有广泛的神经病理，但在rTMS部位附近没有大的病变。一名参与者接受了带有可编程瓣膜的脑室腹腔分流术。两项临床试验分别向右或左背外侧前额叶皮层提供30次rTMS，每天1或2次，涉及300至600次脉冲。一项研究提供了伴随金刚烷胺。监测的安全指标与睡眠、体温、血压、皮肤完整性、出汗、体重减轻、感染和癫痫发作有关。监测指标的平均变化程度为轻度，有75例非严重AE和1例严重AE（癫痫发作）。发生癫痫发作的参与者在服用抗癫痫药物的同时恢复了rTMS，没有进一步的癫痫发作活动。考虑到该患者群体的高风险和保守的患者选择，研究结果表明指定的rTMS方案相对安全；然而，必须监测诱发癫痫发作的可能性。未来对这一人群的研究可以扩大到包括以前因安全性问题而被排除在外的患者。
For persons in states of disordered consciousness (DoC) after severe traumatic brain injury (sTBI), we report cumulative findings from safety examinations, including serious adverse events (AEs) of a repetitive transcranial magnetic stimulation (rTMS) parameter protocol in 2 different studies. Seven persons in states of DoC after sTBI with widespread neuropathology, but no large lesions in proximity to the site of rTMS. One participant had a ventriculoperitoneal shunt with programmable valve. Two clinical trials each providing 30 rTMS sessions to the right or left dorsolateral prefrontal cortex, involving 300 to 600 pulses over 1 or 2 sessions daily. One study provided concomitant amantadine. Safety indicators monitored related to sleep, temperature, blood pressure, skin integrity, sweating, weight loss, infections, and seizure. Average changes for monitored indicators were of mild severity, with 75 nonserious AEs and 1 serious AE (seizure). The participant incurring a seizure resumed rTMS while taking antieplieptics without further seizure activity. Considering elevated risks for this patient population and conservative patient selection, findings indicate a relatively safe profile for the specified rTMS protocols; however, potential for seizure induction must be monitored. Future research for this population can be broadened to include patients previously excluded on the basis of profiles raising safety concerns.