Vagus nerve stimulation to augment recovery from severe traumatic brain injury impeding consciousness: a prospective pilot clinical trial

Vagus nerve stimulation to augment recovery from severe traumatic brain injury impeding consciousness: a prospective pilot clinical trial
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DOI:
10.1179/1743132813y.0000000167
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发表时间:
2013-04-01
影响因子:
1.9
通讯作者:
Samadani, Uzma
Samadani, Uzma
中科院分区:
医学4区
文献类型:
--
作者:
Shi, Chen;Flanagan, Steven R.;Samadani, Uzma

文献摘要

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目标:创伤性脑损伤(TBI)在平民和军人中都有很高的发病率和死亡率。 TBI 的冲击波和其他机制会导致神经元断开和萎缩,从而损害大脑。这种创伤性轴突损伤可导致持续性植物人和最低意识状态(VS 和 MCS),对此的治疗选择有限,包括物理、职业、言语和认知疗法。超过 60,000 名患者接受了迷走神经刺激 (VNS) 来治疗癫痫和抑郁症。除了癫痫发作频率和严重程度降低外,患者还报告情绪增强,与癫痫控制无关的白天嗜睡减少,慢波睡眠增加,认知、记忆和生活质量得到改善。迷走神经的早期刺激可加速大鼠液体冲击性脑损伤后行为和认知恢复的速度和程度。方法:我们最近获得了美国食品和药物管理局 (FDA) 批准的一项试点前瞻性随机交叉试验,以证明通过在患者中放置迷走神经刺激器可客观改善临床结果正在从严重的 TBI 中恢复的人。我们的假设是,刺激迷走神经会导致前脑、丘脑和网状结构的脑血流量和新陈代谢增加,从而促进觉醒和改善意识,从而改善导致 MCS 或 VS 的 TBI 后的结果。讨论:如果这项研究证明 VNS 可以安全、积极地影响结果,那么将提出更大规模的随机前瞻性交叉试验。
Objectives: Traumatic brain injury (TBI) has high morbidity and mortality in both civilian and military populations. Blast and other mechanisms of TBI damage the brain by causing neurons to disconnect and atrophy. Such traumatic axonal injury can lead to persistent vegetative and minimally conscious states (VS and MCS), for which limited treatment options exist, including physical, occupational, speech, and cognitive therapies.More than 60 000 patients have received vagus nerve stimulation (VNS) for epilepsy and depression. In addition to decreased seizure frequency and severity, patients report enhanced mood, reduced daytime sleepiness independent of seizure control, increased slow wave sleep, and improved cognition, memory, and quality of life.Early stimulation of the vagus nerve accelerates the rate and extent of behavioral and cognitive recovery after fluid percussion brain injury in rats.Methods: We recently obtained Food and Drug Administration (FDA) approval for a pilot prospective randomized crossover trial to demonstrate objective improvement in clinical outcome by placement of a vagus nerve stimulator in patients who are recovering from severe TBI. Our hypothesis is that stimulation of the vagus nerve results in increased cerebral blood flow and metabolism in the forebrain, thalamus, and reticular formation, which promotes arousal and improved consciousness, thereby improving outcome after TBI resulting in MCS or VS.Discussion: If this study demonstrates that VNS can safely and positively impact outcome, then a larger randomized prospective crossover trial will be proposed.