Non-invasive vagus nerve stimulation for the acute treatment of episodic and chronic cluster headache: A randomized, double-blind, sham-controlled ACT2 study

Background Clinical observations and results from recent studies support the use of non-invasive vagus nerve stimulation (nVNS) for treating cluster headache (CH) attacks. This study compared nVNS with a sham device for acute treatment in patients with episodic or chronic CH (eCH, cCH). Methods Afte...

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Veröffentlicht in:Cephalalgia 2018-04, Vol.38 (5), p.959-969
Hauptverfasser: Goadsby, Peter J, de Coo, Ilse F, Silver, Nicholas, Tyagi, Alok, Ahmed, Fayyaz, Gaul, Charly, Jensen, Rigmor H, Diener, Hans-Christoph, Solbach, Kasia, Straube, Andreas, Liebler, Eric, Marin, Juana CA, Ferrari, Michel D
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Sprache:eng
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Zusammenfassung:Background Clinical observations and results from recent studies support the use of non-invasive vagus nerve stimulation (nVNS) for treating cluster headache (CH) attacks. This study compared nVNS with a sham device for acute treatment in patients with episodic or chronic CH (eCH, cCH). Methods After completing a 1-week run-in period, subjects were randomly assigned (1:1) to receive nVNS or sham therapy during a 2-week double-blind period. The primary efficacy endpoint was the proportion of all treated attacks that achieved pain-free status within 15 minutes after treatment initiation, without rescue treatment. Results The Full Analysis Set comprised 48 nVNS-treated (14 eCH, 34 cCH) and 44 sham-treated (13 eCH, 31 cCH) subjects. For the primary endpoint, nVNS (14%) and sham (12%) treatments were not significantly different for the total cohort. In the eCH subgroup, nVNS (48%) was superior to sham (6%; p 
ISSN:0333-1024
1468-2982
DOI:10.1177/0333102417744362