title: Some Non-FDA Approved Uses for Neuromodulation in Treating Autonomic Nervous System Disorders: A Discussion of the Preliminary Support.
abstract: BACKGROUND
  Neuromodulation, including cavernous nerve stimulation, gastric electrical stimulation, deep brain stimulation, and vagus nerve stimulation, has been used with success in treating several functional disease conditions. The FDA has approved the use of neuromodulation for a few indications. We discuss in our review article the evidence of using neuromodulation for treating some important disorders involving the autonomic nervous system that are not currently FDA approved.
  
  
  METHODS
  This was a review article that included a systematic online web search for human clinical studies testing the efficacy of neuromodulation in treating erectile dysfunction, gastroparesis, gastroesophageal reflux disease, obesity, asthma, and heart failure. Our review includes all feasibility studies, nonrandomized clinical trials, and randomized controlled trials.
  
  
  RESULTS
  Our systematic literature search found 3, 4, 5, 4, 1, and 4 clinical studies relating to erectile dysfunction, gastroparesis, gastroesophageal reflux disease, obesity, asthma, and heart failure, respectively.
  
  
  CONCLUSIONS
  This review article shows preliminary support based on clinical studies that neuromodulation can be of benefit for patients with important autonomic nervous system disease conditions that are not currently approved by the FDA. All of these investigational uses are encouraging; further studies are necessary and warranted for all indications discussed in this review before achieving FDA approval.
authors.affiliation: University of Cincinnati College of Medicine, Cincinnati, OH, USA.
authors.forename: Samuel
authors.initials: S
authors.lastname: Lee
authors.affiliation: Department of Anesthesiology, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.
authors.forename: Alaa
authors.initials: A
authors.lastname: Abd-Elsayed
mesh_terms: D001341:Autonomic Nervous System / Q000502:physiology*; D001342:Autonomic Nervous System Diseases / Q000628:therapy*; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data; D046690:Deep Brain Stimulation; D004599:Electric Stimulation Therapy / Q000379:methods*; D006801:Humans
keywords: Anesthesiology; GERD; asthma; autonomic nervous system; erectile dysfunction; functional electrical stimulation; gastroparesis; heart failure; neuromodulation; obesity