Volume 15 Supplement 1
EHMTI-0227. Therapeutic effectiveness of sphenopalatine ganglion (SPG) stimulation for cluster headache – pathway registry study interim results at 6 months
© Jürgens et al; licensee Springer. 2014
Published: 18 September 2014
The Pathway Registry is an open label registry of SPG stimulation therapy for cluster headache treatment. In a previous randomized, double-blind, multi-center study (Pathway CH-1 study) 68% of patients experienced clinically significant improvements.
The aim of this interim analysis is to evaluate acute and/or preventive therapeutic effectiveness at 6 months following insertion of an SPG neurostimulator.
Therapeutic effectiveness (acute pain response following SPG stimulation and/or attack frequency reduction) was analyzed during the first six months following SPG neurostimulator insertion. Acute pain responders achieved relief from moderate or greater pain, or freedom from mild pain in ≥50% of analyzable attacks (with completed diary questions). Frequency responders achieved ≥50% attack frequency reduction at the six month study visit (evaluated over the previous four weeks), versus the 4 week baseline period.
49 patients have been enrolled, 18 completed follow-up through six months[RJ1] (189 days post-insertion, range 149-238). Average baseline attack frequency was 28.4 attacks/week (range 0-70), and the average attack frequency at 6 months was 17.3 attacks/week (range 0-70), a 40% reduction. 67% (12/18) were responders. Of the 12 responders, 67% (N=8) were acute responders, treating 86% of their attacks effectively (N=546). 75% (N=9) were frequency responders; frequency reduced by 90% (from 22.3 at baseline to 2.1 (range 0-8) attacks/week). 5 patients were both acute and frequency responders.
Interim data from a registry of cluster headache patients continues to demonstrate the effectiveness of SPG stimulation therapy.
This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.