TY - JOUR
T1 - Safety and efficacy of peripheral nerve stimulation of the occipital nerves for the management of chronic migraine
T2 - Results from a randomized, multicenter, double-blinded, controlled study
AU - Silberstein, Stephen D.
AU - Dodick, David W.
AU - Saper, Joel
AU - Huh, Billy
AU - Slavin, Konstantin V.
AU - Sharan, Ashwini
AU - Reed, Ken
AU - Narouze, Samer
AU - Mogilner, Alon
AU - Goldstein, Jerome
AU - Trentman, Terrence
AU - Vaisman, Julien
AU - Ordia, Joseph
AU - Weber, Peter
AU - Deer, Timothy
AU - Levy, Robert
AU - Diaz, Roni L.
AU - Washburn, Stephanie N.
AU - Mekhail, Nagy
PY - 2012/12
Y1 - 2012/12
N2 - Background: Chronic migraine (CM) is a debilitating neurological disorder with few treatment options. Peripheral nerve stimulation (PNS) of the occipital nerves is a potentially promising therapy for CM patients. Methods: In this randomized, controlled multicenter study, patients diagnosed with CM were implanted with a neurostimulation device near the occipital nerves and randomized 2:1 to active (n=105) or sham (n=52) stimulation. The primary endpoint was a difference in the percentage of responders (defined as patients that achieved a 50% reduction in mean daily visual analog scale scores) in each group at 12 weeks. Results: There was not a significant difference in the percentage of responders in the Active compared with the Control group (95% lower confidence bound (LCB) of 0.06; p=0.55). However, there was a significant difference in the percentage of patients that achieved a 30% reduction (p=0.01). Importantly, compared with sham-treated patients, there were also significant differences in reduction of number of headache days (Active Group=6.1, baseline=22.4; Control Group=3.0, baseline=20.1; p=0.008), migraine-related disability (p=0.001) and direct reports of pain relief (p=0.001). The most common adverse event was persistent implant site pain. Conclusion: Although this study failed to meet its primary endpoint, this is the first large-scale study of PNS of the occipital nerves in CM patients that showed significant reductions in pain, headache days, and migraine-related disability. Additional controlled studies using endpoints that have recently been identified and accepted as clinically meaningful are warranted in this highly disabled patient population with a large unmet medical need.
AB - Background: Chronic migraine (CM) is a debilitating neurological disorder with few treatment options. Peripheral nerve stimulation (PNS) of the occipital nerves is a potentially promising therapy for CM patients. Methods: In this randomized, controlled multicenter study, patients diagnosed with CM were implanted with a neurostimulation device near the occipital nerves and randomized 2:1 to active (n=105) or sham (n=52) stimulation. The primary endpoint was a difference in the percentage of responders (defined as patients that achieved a 50% reduction in mean daily visual analog scale scores) in each group at 12 weeks. Results: There was not a significant difference in the percentage of responders in the Active compared with the Control group (95% lower confidence bound (LCB) of 0.06; p=0.55). However, there was a significant difference in the percentage of patients that achieved a 30% reduction (p=0.01). Importantly, compared with sham-treated patients, there were also significant differences in reduction of number of headache days (Active Group=6.1, baseline=22.4; Control Group=3.0, baseline=20.1; p=0.008), migraine-related disability (p=0.001) and direct reports of pain relief (p=0.001). The most common adverse event was persistent implant site pain. Conclusion: Although this study failed to meet its primary endpoint, this is the first large-scale study of PNS of the occipital nerves in CM patients that showed significant reductions in pain, headache days, and migraine-related disability. Additional controlled studies using endpoints that have recently been identified and accepted as clinically meaningful are warranted in this highly disabled patient population with a large unmet medical need.
KW - Chronic migraine
KW - headache
KW - neuromodulation
KW - neurostimulation
KW - occipital nerve stimulation
KW - peripheral nerve stimulation
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U2 - 10.1177/0333102412462642
DO - 10.1177/0333102412462642
M3 - Article
C2 - 23034698
AN - SCOPUS:84877090562
SN - 0333-1024
VL - 32
SP - 1165
EP - 1179
JO - Cephalalgia
JF - Cephalalgia
IS - 16
ER -