title: Cervical 10 kHz spinal cord stimulation in the management of chronic, medically refractory migraine: A prospective, open-label, exploratory study.
abstract: BACKGROUND
  A significant minority of chronic migraine (CM) subjects fail conventional medical treatment (rCM), becoming highly disabled. Implantation of an occipital nerve stimulator is a therapeutic option for these subjects. Paresthesia-free cervical 10 kHz spinal cord stimulation (HF10 SCS) may provide an alternative. We report the results of a prospective, open-label, exploratory study assessing the long-term safety, tolerability and efficacy of cervical HF10 SCS in cohort of rCM subjects.
  
  
  METHODS
  Included subjects were diagnosed with CM by an experienced headache specialist with the aid of an hourly headache diary. They were refractory to conventional medical treatments including onabotulinumtoxin-A injections. Medication overuse headache was not an exclusion criteria. Enrolled subjects underwent a 2- to 4-week tunnelled cervical HF10 SCS trial followed by a permanent system implant if a significant, subjective reduction in headache intensity/episodes was reported during the trial. Subjects were evaluated at baseline and 6 months after implantation with the aid of monthly diaries and headache-specific questionnaires.
  
  
  RESULTS
  Seventeen subjects underwent a trial of cervical HF10 SCS; 14 were still implanted at 6 months (one trial failure, one trial infection, one implant site infection). Seven of the 14 subjects had >30% reduction in headache days. The average reduction in headache days was 6.9 for the overall population and 12.9 among the responders. Three subjects reported tenderness over the IPG/connection site, and one had a lead migration that required surgical revision.
  
  
  CONCLUSIONS
  Paresthesia-free cervical HF10 SCS may be a safe and effective therapeutic option for chronic migraineurs refractory to conventional treatments.
authors.affiliation: Department of Medical and Surgical Science and Translational Medicine, Sapienza University of Rome and Pain Therapy Unit, Sant'Andrea Hospital, Italy.
authors.forename: R
authors.initials: R
authors.lastname: Arcioni
authors.affiliation: Pain Management & Neuromodulation Centre, Guy's & St Thomas' NHS Foundation Trust, London, UK.
authors.forename: S
authors.initials: S
authors.lastname: Palmisani
authors.affiliation: Department of Medical and Surgical Science and Translational Medicine, Sapienza University of Rome and Pain Therapy Unit, Sant'Andrea Hospital, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Mercieri
authors.affiliation: Department of Medical and Surgical Science and Translational Medicine, Sapienza University of Rome and Pain Therapy Unit, Sant'Andrea Hospital, Italy.
authors.forename: V
authors.initials: V
authors.lastname: Vano
authors.affiliation: Department of Medical and Surgical Science and Translational Medicine, Sapienza University of Rome and Pain Therapy Unit, Sant'Andrea Hospital, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Tigano
authors.affiliation: Pain Management & Neuromodulation Centre, Guy's & St Thomas' NHS Foundation Trust, London, UK.
authors.forename: T
authors.initials: T
authors.lastname: Smith
authors.affiliation: Department of Clinical and Molecular Medicine, Sapienza University of Rome and Regional Referral Headache Centre, Sant'Andrea Hospital, Italy.
authors.forename: M R D
authors.initials: MR
authors.lastname: Fiore
authors.affiliation: Pain Management & Neuromodulation Centre, Guy's & St Thomas' NHS Foundation Trust, London, UK.
authors.forename: A
authors.initials: A
authors.lastname: Al-Kaisy
authors.affiliation: Department of Clinical and Molecular Medicine, Sapienza University of Rome and Regional Referral Headache Centre, Sant'Andrea Hospital, Italy.
authors.forename: P
authors.initials: P
authors.lastname: Martelletti
mesh_terms: D000328:Adult; D002574:Cervical Vertebrae; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000628:therapy*; D017063:Outcome Assessment, Health Care; D010865:Pilot Projects; D062187:Spinal Cord Stimulation / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*