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

David William Dodick, Stephen D. Silberstein, Kenneth L. Reed, Timothy R. Deer, Konstantin V. Slavin, Billy Huh, Ashwini D. Sharan, Samer Narouze, Alon Y. Mogilner, Terrence L. Trentman, Joe Ordia, Julien Vaisman, Jerome Goldstein, Nagy Mekhail

Research output: Contribution to journalArticle

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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. Conclusion: 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. Trial registration: Clinical trials.gov (NCT00615342).

Original languageEnglish (US)
Pages (from-to)344-358
Number of pages15
JournalCephalalgia
Volume35
Issue number4
DOIs
StatePublished - Apr 16 2015

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Migraine Disorders
Peripheral Nerves
Headache
Safety
Population
Pain Measurement
Pain
Equipment and Supplies
Research Ethics Committees
Neuralgia
Hospitalization
Randomized Controlled Trials
Quality of Life
Clinical Trials
Control Groups

Keywords

  • chronic migraine
  • neuromodulation
  • occipital nerve
  • Peripheral nerve stimulation

ASJC Scopus subject areas

  • Clinical Neurology

Cite this

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. / Dodick, David William; Silberstein, Stephen D.; Reed, Kenneth L.; Deer, Timothy R.; Slavin, Konstantin V.; Huh, Billy; Sharan, Ashwini D.; Narouze, Samer; Mogilner, Alon Y.; Trentman, Terrence L.; Ordia, Joe; Vaisman, Julien; Goldstein, Jerome; Mekhail, Nagy.

In: Cephalalgia, Vol. 35, No. 4, 16.04.2015, p. 344-358.

Research output: Contribution to journalArticle

Dodick, DW, Silberstein, SD, Reed, KL, Deer, TR, Slavin, KV, Huh, B, Sharan, AD, Narouze, S, Mogilner, AY, Trentman, TL, Ordia, J, Vaisman, J, Goldstein, J & Mekhail, N 2015, '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', Cephalalgia, vol. 35, no. 4, pp. 344-358. https://doi.org/10.1177/0333102414543331
Dodick, David William ; Silberstein, Stephen D. ; Reed, Kenneth L. ; Deer, Timothy R. ; Slavin, Konstantin V. ; Huh, Billy ; Sharan, Ashwini D. ; Narouze, Samer ; Mogilner, Alon Y. ; Trentman, Terrence L. ; Ordia, Joe ; Vaisman, Julien ; Goldstein, Jerome ; Mekhail, Nagy. / 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. In: Cephalalgia. 2015 ; Vol. 35, No. 4. pp. 344-358.
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AU - Reed, Kenneth L.

AU - Deer, Timothy R.

AU - Slavin, Konstantin V.

AU - Huh, Billy

AU - Sharan, Ashwini D.

AU - Narouze, Samer

AU - Mogilner, Alon Y.

AU - Trentman, Terrence L.

AU - Ordia, Joe

AU - Vaisman, Julien

AU - Goldstein, Jerome

AU - Mekhail, Nagy

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N2 - 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. Conclusion: 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. Trial registration: Clinical trials.gov (NCT00615342).

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