TY - JOUR
T1 - Safety and efficacy of peripheral nerve stimulation of the occipital nerves for the management of chronic migraine
T2 - Long-term results from a randomized, multicenter, double-blinded, controlled study
AU - Dodick, David W.
AU - Silberstein, Stephen D.
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
N1 - Funding Information:
David W. Dodick M.D., within the past 12 months, has served on advisory boards and/or has consulted for Allergan, Amgen, Alder, Arteaus, Pfizer, Colucid, Merck, ENeura, NuPathe, Eli Lilly & Company, Autonomic Technologies, Ethicon J&J, Zogenix, Supernus, Labrys. Dr Dodick has received funding for travel, speaking, editorial activities or royalty payments from: IntraMed, SAGE Publishing, Sun Pharma, Allergan, Oxford University Press, American Academy of Neurology, West Virginia University Foundation; Canadian Headache Society; Healthlogix, Wiley, Universal Meeting Management, WebMD, UptoDate, Oregon Health Science Center, Starr Clinical, Decision Resources, Synergy. Because of Dr Dodick's affiliation with the journal's publisher, he was not involved in the editorial review process for this manuscript. Dr Mogilner received consulting fees, grant support and fellowship support from Medtronic Neurological, fees for serving on an advisory board, as well as grant support from St. Jude Medical and Boston Scientific. Dr Mogilner serves on editorial board of Neuromodulation. Dr Silberstein is on the advisory panel of and receives honoraria from Allergan, Artaeus, Electrocore, and Neuralieve. He serves as a consultant for and receives honoraria from Amgen, Labrys Biologics, MAP, and Zogenix. His employer receives research support from AGA, Allergan, Amgen, Cumberland, ElectroCore, Labrys, Merz, OptiNose, and Troy Healthcare. Dr Deer is a consultant for St. Jude Medical, Axionics, Medtronic, Nevro, Spinal Modulation and Bioness. Dr Sharan is a consultant for Medtronic, has received a speaker honorarium and research grant from St. Jude Medical, and is an owner of Integrate Care Pharmacy and ICVRx. Dr Slavin is a consultant and/or advisory board member for St. Jude Medical, Medtronic, Boston Scientific, Bioness, Greatbatch, Biotronik, W.L.Gore, and Nevro, receiving educational grants/research support from St. Jude Medical, Medtronic, Boston Scientific and Bioness, and honoraria from Karger and Wiley. Drs Mekhail, Vaisman, Reed, Trentman, Goldstein, Narouze and Ordia, report no conflicts of interest or specific financial disclosures. Acknowledgements
Publisher Copyright:
© 2014 International Headache Society.
PY - 2015/4/16
Y1 - 2015/4/16
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).
AB - 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).
KW - Peripheral nerve stimulation
KW - chronic migraine
KW - neuromodulation
KW - occipital nerve
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U2 - 10.1177/0333102414543331
DO - 10.1177/0333102414543331
M3 - Article
C2 - 25078718
AN - SCOPUS:84924813245
SN - 0333-1024
VL - 35
SP - 344
EP - 358
JO - Cephalalgia
JF - Cephalalgia
IS - 4
ER -