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J Headache PainJ Headache PainThe Journal of Headache and Pain1129-23691129-2377Springer 1129-2377-15-S1-I810.1186/1129-2377-15-S1-I8Meeting AbstractEHMTI-0362. Non-invasive vagus nerve stimulation with gammacore® for prevention and acute treatment of chronic cluster headache: report from the extension phase of the preva study Gaul C 1Diener H 2Solbach K 2Silver N 3Straube A 4Magis D 5Reuter U 6Andersson A 7Liebler EJ 81 Migraine and Headache Clinic, University of Duisburg-Essen, Königstein, Germany2 Department of Neurology, University Hospital Essen, Essen, Germany3 Department of Neurology, Walton Centre for Neurology and Neurosurgery, Liverpool, UK4 Department of Neurology, Ludwig Maximilian University of Munich, Munich, Germany5 Department of Neurology, Liège University, Liège, Belgium6 Berlin NeuroImaging Center, Charité University Hospital, Berlin, Germany7 Clinical Affairs, electroCore Medical, Gothenburg, Sweden8 Scientific Medical and Clinical Affairs, electroCore LLC, Basking Ridge, USA2014 18 9 2014 15 Suppl 1 Abstracts from the 4th European Headache and Migraine Trust International Congress: EHMTIC 2014Publication costs for this supplement were funded by the conference.I8 I8 Copyright © 2014 Gaul et al; licensee Springer.2014Gaul et al; licensee Springer.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.18-21 September 2014 4th European Headache and Migraine Trust International Congress: EHMTIC 2014 Copenhagen, Denmark
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Introduction
Neuromodulatory devices offer additional treatment options to refractory pharmacologic intervention for the treatment of chronic cluster headaches (CH). Clinical experience suggests vagus nerve stimulation (VNS) may be beneficial; however, inherent risks are associated with surgical implantation. As such, a need for the development of a non-invasive VNS (nVNS) modality exists.

Aim
Evaluate the long-term effects of an nVNS device (gammaCore®) in the extension phase of the Prevention and Acute (PREVA) Treatment of Chronic Cluster Headache study.

Methods
This randomized, controlled study consisted of a 2-week run-in phase, followed by a 4-week randomized (1:1; nVNS vs standard of care [SoC]) phase, and a 4-week extension phase. During the extension phase, subjects delivered 3 consecutive 90-second stimulations prophylactically twice daily (mandatory, right side only) and optionally at the onset of a CH attack (2 stimulations on headache side, 1 on opposite side) for rescue treatment. Efficacy end points evaluated in the extension phase were mean number of all CH attacks, pain intensity (range: no pain to very severe pain), treatment success rate, and use of rescue medication. Safety was assessed by monitoring the frequency of adverse events.

Results
A total of 97 subjects, across 10 European sites, were randomized to treatment; 90 entered the extension phase. All data has been collected and will be available for connie39@example.com.

Conclusion
Findings from PREVA are expected to provide further evidence of the sustained clinical effects and continued safety of nVNS in the treatment of chronic CH.

Abstract submitted on behalf of the PREVA Study Investigators.


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