title: Vagus nerve stimulation to augment recovery from severe traumatic brain injury impeding consciousness: a prospective pilot clinical trial.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  If this study demonstrates that VNS can safely and positively impact outcome, then a larger randomized prospective crossover trial will be proposed.
authors.affiliation: Department of Neurosurgery, New York University School of Medicine and NYU Langone Medical Center, New York, NY, USA.
authors.forename: Chen
authors.initials: C
authors.lastname: Shi
authors.forename: Steven R
authors.initials: SR
authors.lastname: Flanagan
authors.forename: Uzma
authors.initials: U
authors.lastname: Samadani
mesh_terms: D000293:Adolescent; D000328:Adult; D001930:Brain Injuries / Q000150:complications / Q000628:therapy*; D003244:Consciousness Disorders / Q000209:etiology / Q000628:therapy*; D018592:Cross-Over Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D020127:Recovery of Function; D012107:Research Design; D055536:Vagus Nerve Stimulation; D055815:Young Adult