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. CONCLUSION: Paresthesia-free cervical HF10 SCS may be a safe and effective therapeutic option for chronic migraineurs refractory to conventional treatments.

Cervical 10 kHz spinal cord stimulation in the management of chronic, medically refractory migraine. a prospective, open-label, exploratory study / Arcioni, Roberto; S., Palmisani; Mercieri, Marco; V., Vano; S., Tigano; T., Smith; M. R., Del Fiore; A., Al Kaisy; Martelletti, Paolo. - In: EUROPEAN JOURNAL OF PAIN. - ISSN 1090-3801. - STAMPA. - 20:1(2016), pp. 70-78. [10.1002/ejp.692]

Cervical 10 kHz spinal cord stimulation in the management of chronic, medically refractory migraine. a prospective, open-label, exploratory study

ARCIONI, Roberto
Primo
;
MERCIERI, MARCO;MARTELLETTI, Paolo
Ultimo
2016

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. CONCLUSION: Paresthesia-free cervical HF10 SCS may be a safe and effective therapeutic option for chronic migraineurs refractory to conventional treatments.
2016
adult; cervical vertebrae; female; follow-up studies; humans; male; middle aged; migraine disorders; pilot projects; spinal cord stimulation; outcome assessment
01 Pubblicazione su rivista::01a Articolo in rivista
Cervical 10 kHz spinal cord stimulation in the management of chronic, medically refractory migraine. a prospective, open-label, exploratory study / Arcioni, Roberto; S., Palmisani; Mercieri, Marco; V., Vano; S., Tigano; T., Smith; M. R., Del Fiore; A., Al Kaisy; Martelletti, Paolo. - In: EUROPEAN JOURNAL OF PAIN. - ISSN 1090-3801. - STAMPA. - 20:1(2016), pp. 70-78. [10.1002/ejp.692]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11573/781947
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