The Department of Veterans Affairs (VA), Research Service, Edward Hines Jr VA Hospital, Hines, Illinois (Drs Kletzel, Aaronson, Guernon, Walsh, Patil, Steiner, Pacheco, and Bender Pape and Mr Chaudhry); The Department of Veterans Affairs Mental Health Service Line, Hines VA, Hines, Illinois (Dr Aaronson) Marianjoy Rehabilitation Hospital/Northwestern Medicine, Wheaton, Illinois (Drs Guernon and Bender Pape); Battle Creek VA Medical Center, Kalamazoo, Michigan (Dr Carbone); Department of Physical Medicine and Rehabilitation, Northwestern University Feinberg School of Medicine, Chicago, Illinois (Drs Roth, Rosenow, and Bender Pape); Departments of Neurosurgery and Neurology, Northwestern University Feinberg School of Medicine, Chicago, Illinois (Dr Rosenow); The Department of Psychiatry and Behavioral Sciences, Northwestern University Feinberg School of Medicine Chicago, Illinois (Drs Aaronson and Pacheco); Chicago Medical School, Rosalind Franklin University of Science and Medicine, North Chicago, Illinois, (Dr Conneely); Loyola University Chicago, Stritch School of Medicine, Maywood, Illinois (Drs Patil and Steiner); University of Illinois at Chicago, Chicago, Illinois (Mr Chaudhry).
J Head Trauma Rehabil. 2020 Nov-Dec;35(6):430-438. doi: 10.1097/HTR.0000000000000636.
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.
对于因严重创伤性脑损伤（sTBI）而处于意识障碍（DoC）状态的患者，我们报告了两项不同研究中重复经颅磁刺激（rTMS）参数方案的安全性检查累积结果，包括严重不良事件（AE）。
7 名因 sTBI 而处于 DoC 状态的患者，其广泛存在神经病理学改变，但在 rTMS 部位附近无大的病变。其中 1 名患者存在可程控的脑室-腹腔分流管。
两项临床试验分别为右或左背外侧前额叶皮质提供 30 次 rTMS 治疗，每天 1 或 2 次，每次 300 至 600 脉冲。其中一项研究同时提供金刚烷胺。监测与睡眠、体温、血压、皮肤完整性、出汗、体重减轻、感染和癫痫相关的安全性指标。
监测指标的平均变化为轻度，75 例为非严重不良事件，1 例为严重不良事件（癫痫发作）。发生癫痫的患者在接受抗癫痫药物治疗的同时恢复 rTMS 治疗，无进一步癫痫发作活动。
考虑到该患者群体的风险较高以及对患者的保守选择，这些发现表明特定 rTMS 方案具有相对安全的特征；然而，必须监测癫痫诱发的潜在风险。对于该患者群体的未来研究可以扩大范围，包括以前因安全性问题而被排除的患者。
