Abstract
experienced both. Of the 12 frequency responders, HA frequency was reduced to ≤2 HA/week in 9 subjects. Eight (29%) of the 27 did not respond or did not provide sufficient data for evaluation. Most subjects (47%) experienced transient, mild to moderate numbness within the second division of the trigeminal nerve post implant with 62% resolving within the first three months. Conclusions Results suggest that acute, on-demand SPG stimulation using the ATI Neurostimulation System has acute and preventive effects and is an effective novel therapy for CCH. In this study, 70% of subjects responded to the therapy.
Highlights
The pain and autonomic symptoms of cluster headache result from activation of the trigeminal parasympathetic reflex, mediated through the SPG [1,2]
One subject remains in experimental period (EXP), 1 skipped EXP, 2 were explanted due to early lead migration, and 1 did not complete the implant due to difficult anatomy
Pain relief was achieved in 67% of headache attack (HA) (n=190) treated with full compared to 8% (n=183) with sub-perception and 8% (n=189) with placebo stimulation
Summary
We aimed to investigate the safety and efficacy of SPG stimulation for the acute treatment of CCH
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