title: Safety and efficacy of peripheral nerve stimulation of the occipital nerves for the management of chronic migraine: long-term results from a randomized, multicenter, double-blinded, controlled study.
abstract: BACKGROUND
  Recent studies evaluated short-term efficacy and safety of peripheral nerve stimulation (PNS) of the occipital nerves for managing chronic migraine. We present 52-week safety and efficacy results from an open-label extension of a randomized, sham-controlled trial.
  
  
  METHODS
  In this institutional review board-approved, randomized, multicenter, double-blinded study, patients were implanted with a neurostimulation system, randomized to an active or control group for 12 weeks, and received open-label treatment for an additional 40 weeks. Outcomes collected included number of headache days, pain intensity, migraine disability assessment (MIDAS), Zung Pain and Distress (PAD), direct patient reports of headache pain relief, quality of life, satisfaction and adverse events. Statistical tests assessed change from baseline to 52 weeks using paired t-tests. Intent-to-treat (ITT) analyses of all patients (N = 157) and analyses of only patients who met criteria for intractable chronic migraine (ICM; N = 125) were performed.
  
  
  RESULTS
  Headache days were significantly reduced by 6.7 (±8.4) days in the ITT population (p < 0.001) and by 7.7 (±8.7) days in the ICM population (p < 0.001). The percentages of patients who achieved a 30% and 50% reduction in headache days and/or pain intensity were 59.5% and 47.8%, respectively. MIDAS and Zung PAD scores were significantly reduced for both populations. Excellent or good headache relief was reported by 65.4% of the ITT population and 67.9% of the ICM population. More than half the patients in both cohorts were satisfied with the headache relief provided by the device. A total of 183 device/procedure-related adverse events occurred during the study, of which 18 (8.6%) required hospitalization and 85 (40.7%) required surgical intervention; 70% of patients experienced an adverse event.
  
  
  CONCLUSIONS
  Our results support the 12-month efficacy of PNS of the occipital nerves for headache pain and disability associated with chronic migraine. More emphasis on adverse event mitigation is needed in future research.
  
  
  BACKGROUND
  Clinical trials.gov (NCT00615342).
authors: Mayo Clinic Hospital, AZ, USA Dodick.David@mayo.edu.
authors: David W
authors: DW
authors: Dodick
authors: Jefferson Headache Center, PA, USA.
authors: Stephen D
authors: SD
authors: Silberstein
authors: Reed Migraine Centers, TX, USA.
authors: Kenneth L
authors: KL
authors: Reed
authors: The Center for Pain Relief, WV, USA.
authors: Timothy R
authors: TR
authors: Deer
authors: Department of Neurosurgery, University of Illinois, IL, USA.
authors: Konstantin V
authors: KV
authors: Slavin
authors: Department of Pain Medicine, University of Texas MD Anderson Cancer Center, TX, USA.
authors: Billy
authors: B
authors: Huh
authors: Department of Neurosurgery, Thomas Jefferson University, PA, USA.
authors: Ashwini D
authors: AD
authors: Sharan
authors: Center for Pain Relief, Summa Western Reserve Hospital, OH, USA.
authors: Samer
authors: S
authors: Narouze
authors: Center for Neuromodulation, Department of Neurosurgery, NYU Langone Medical Center, NY, USA.
authors: Alon Y
authors: AY
authors: Mogilner
authors: Department of Anesthesiology, Mayo Clinic Hospital, AZ, USA.
authors: Terrence L
authors: TL
authors: Trentman
authors: Pain and Wellness Center, MA, USA.
authors: Joe
authors: J
authors: Ordia
authors: Pain and Wellness Center, MA, USA.
authors: Julien
authors: J
authors: Vaisman
authors: San Francisco Headache Clinic, CA, USA.
authors: Jerome
authors: J
authors: Goldstein
authors: Cleveland Clinic, OH, USA.
authors: Nagy
authors: N
authors: Mekhail
mesh_terms: D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D058542:Implantable Neurostimulators; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000628:therapy*; D010525:Peripheral Nerves / Q000502:physiology*; D012886:Skull / Q000294:innervation; D004561:Transcutaneous Electric Nerve Stimulation / Q000379:methods*; D016896:Treatment Outcome; D055815:Young Adult
keywords: Peripheral nerve stimulation; chronic migraine; neuromodulation; occipital nerve