Objectives: A significant minority of chronic migraine (CM) patients do not respond to conventional medical treatment. Occipital nerve stimulation is a therapeutic option for refractory CM (rCM). However, randomized studies have failed to demonstrate efficacy. Cervical 10 kHz spinal cord stimulation (10 kHz-SCS) may provide a superior alternative to occipital stimulation.We report the preliminary results of a prospective, open-label, feasibility study to assess safety and tolerability cervical 10 kHz-SCS in rCM patients. Methods: The study had EC approval and the subjects gave informed consent. Included subjects were diagnosed with CM by an experienced headache specialist according to IHS guidelines, were refractory to medical treatments as defined by the Refractory Headache Special Interest Section of the AHS, and had failed Botox treatment. Medication Overuse headache was not excluded. Patients underwent a 10 kHz SCStrial followed by a permanent implant if a significant reduction in headache intensity/episodes was reported during the trial. Results: Eighteen patients underwent a trial and 15 had a permanent system implanted (2 trial failure and 1 infection). At 6 months, 1 subject was explanted due to infection. Eight out of 14 had >30% reduction in headache days (responder rate 57%, average headache days reduction from baseline 12.6 ± 3.1 days). Three patients developed IPG tenderness and one had a lead migration that required surgical revision. Conclusion: Paresthesia-free cervical 10 kHz-SCS may be an effective therapeutic option for chronic migraineurs refractory to conventional medications and Botox treatment. Conflict of interest.
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CITATION STYLE
Palmisani, S., Smith, T., Arcioni, R., Mercieri, M., Vano, V., Tigano, S., … Martelletti, P. (2014). EHMTI-0322. Effect of cervical epidural 10khz spinal cord stimulation on patients suffering from chronic, medically-refractory migraine. The Journal of Headache and Pain, 15(S1). https://doi.org/10.1186/1129-2377-15-s1-g22