title: Safety and efficacy of peripheral nerve stimulation of the occipital nerves for the management of chronic migraine: results from a randomized, multicenter, double-blinded, controlled study.
abstract: BACKGROUND
  Chronic migraine (CM) is a debilitating neurological disorder with few treatment options. Peripheral nerve stimulation (PNS) of the occipital nerves is a potentially promising therapy for CM patients.
  
  
  METHODS
  In this randomized, controlled multicenter study, patients diagnosed with CM were implanted with a neurostimulation device near the occipital nerves and randomized 2:1 to active (n = 105) or sham (n = 52) stimulation. The primary endpoint was a difference in the percentage of responders (defined as patients that achieved a ≥50% reduction in mean daily visual analog scale scores) in each group at 12 weeks.
  
  
  RESULTS
  There was not a significant difference in the percentage of responders in the Active compared with the Control group (95% lower confidence bound (LCB) of -0.06; p = 0.55). However, there was a significant difference in the percentage of patients that achieved a 30% reduction (p = 0.01). Importantly, compared with sham-treated patients, there were also significant differences in reduction of number of headache days (Active Group = 6.1, baseline = 22.4; Control Group = 3.0, baseline = 20.1; p = 0.008), migraine-related disability (p = 0.001) and direct reports of pain relief (p = 0.001). The most common adverse event was persistent implant site pain.
  
  
  CONCLUSIONS
  Although this study failed to meet its primary endpoint, this is the first large-scale study of PNS of the occipital nerves in CM patients that showed significant reductions in pain, headache days, and migraine-related disability. Additional controlled studies using endpoints that have recently been identified and accepted as clinically meaningful are warranted in this highly disabled patient population with a large unmet medical need.
  
  
  BACKGROUND
  Clinical trials.gov (NCT00615342).
authors.affiliation: Thomas Jefferson University, Philadelphia, PA, USA. stephen.silberstein@jefferson.edu
authors.forename: Stephen D
authors.initials: SD
authors.lastname: Silberstein
authors.forename: David W
authors.initials: DW
authors.lastname: Dodick
authors.forename: Joel
authors.initials: J
authors.lastname: Saper
authors.forename: Billy
authors.initials: B
authors.lastname: Huh
authors.forename: Konstantin V
authors.initials: KV
authors.lastname: Slavin
authors.forename: Ashwini
authors.initials: A
authors.lastname: Sharan
authors.forename: Ken
authors.initials: K
authors.lastname: Reed
authors.forename: Samer
authors.initials: S
authors.lastname: Narouze
authors.forename: Alon
authors.initials: A
authors.lastname: Mogilner
authors.forename: Jerome
authors.initials: J
authors.lastname: Goldstein
authors.forename: Terrence
authors.initials: T
authors.lastname: Trentman
authors.forename: Julien
authors.initials: J
authors.lastname: Vaisman
authors.forename: Julien
authors.initials: J
authors.lastname: Vaisma
authors.forename: Joseph
authors.initials: J
authors.lastname: Ordia
authors.forename: Peter
authors.initials: P
authors.lastname: Weber
authors.forename: Timothy
authors.initials: T
authors.lastname: Deer
authors.forename: Robert
authors.initials: R
authors.lastname: Levy
authors.forename: Roni L
authors.initials: RL
authors.lastname: Diaz
authors.forename: Stephanie N
authors.initials: SN
authors.lastname: Washburn
authors.forename: Nagy
authors.initials: N
authors.lastname: Mekhail
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002908:Chronic Disease; D004311:Double-Blind Method; D004599:Electric Stimulation Therapy / Q000009:adverse effects / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000628:therapy*; D009333:Neck / Q000294:innervation*; D009777:Occipital Bone; D017060:Patient Satisfaction; D010525:Peripheral Nerves / Q000502:physiology*; D016896:Treatment Outcome; D055815:Young Adult