In episodic cluster headaches, but not chronic cluster headaches, acute noninvasive vagus nerve stimulation (nVNS) led to significantly higher rates of participants without pain, higher rates of responders, and greater decreases in pain intensity than sham therapy. These findings were published in Cephalalgia.
To study nVNS compared with sham treatment for episodic and chronic cluster headaches, researchers conducted a pivotal, randomized, double-blind, sham-controlled prospective study (clinicaltrials.gov Identifier: NCT01958125) in 4 European countries at 9 tertiary care sites between September 10, 2013, and October 14, 2014.
After a 1-week run-in period, participants were randomly assigned to a 2-week, double-blind period during which they were treated with either nVNS or a sham device. There was also a 2-week, open-label period in which all participants were treated with nVNS therapy.
The total number of 48 participants were treated with nVNS (14 in episodic cluster headache group and 34 in chronic cluster headache group) and 44 treated with sham therapy (13 in episodic cluster headache group and 31 in chronic cluster headache group); 495 attacks were treated with active nVNS and 400 were treated with sham therapy.
The study’s primary end point was the percentage of all treated attacks that achieved a status of no pain within 15 minutes of the start of treatment. In both episodic and chronic cluster head treatment groups there was no significant difference in this outcome (14% achieved this with nVNS, 12% with sham therapy).
There was also no significant difference in the chronic cluster headache treatment groups (5% achieved pain-free status with nVNS; 13% achieved pain-free status with sham).
However, there was a significant improvement in episodic cluster headaches in the nVNS group (48%) compared with the sham therapy group (6%; P <.01).
The researchers concluded that nVNS, which was safe and well tolerated in all participants, may be able to fill a gap in the treatment of cluster headache. “These results confirm those of previous studies, indicating that nVNS is a safe and effective treatment that can be used alongside other therapies in patients with [episodic cluster headaches] without increasing the risk for drug interactions or adverse events. The data do not support the acute use of nVNS in patients with [chronic cluster headaches].”
Disclosures: PJ Goadsby reports grants and personal fees from Allergan, Amgen, and Eli Lilly and Company; and personal fees from Akita Biomedical, Alder Biopharmaceuticals, Avanir Pharma, Cipla Ltd, Dr Reddy’s Laboratories, eNeura, Novartis, Pfizer Inc, Quest Diagnostics, Scion, Teva Pharmaceuticals, Trigemina Inc., Scion; and personal fees from MedicoLegal work, Journal Watch, Up-to-Date, Massachusetts Medical Society, Oxford University Press; and in addition, Dr. Goadsby has a patent Magnetic stimulation for headache assigned to eNeura. IF de Coo has received travel grants from electroCore, LLC. N Silver has received honoraria from Allergan and electroCore, LLC, and investigator fees paid to The Walton Centre. A Tyagi has received honoraria from Allergan, Inc., and electroCore, LLC. F Ahmed has nothing to disclose. C Gaul has received honoraria from Allergan; electroCore, LLC; Gru¨ nenthal; Desitin; Bayer; Boehringer Ingelheim; Autonomic Technologies; Reckitt Benckiser; Ratiopharm GmbH; Novartis; Lilly Deutschland; Teva and Hormosan. Dr. Gaul has no ownership interests and does not own any pharmaceutical company stocks. RH Jensen has given lectures and conducted clinical trials for Autonomic Technologies; electroCore, LLC; and Eli Lilly and Company. H-C Diener has received honoraria for participation in clinical trials and for contributions to advisory boards and oral presentations sponsored by Addex Pharma; Adler; Allergan; Almirall; Amgen; Autonomic Technologies; AstraZeneca; Bayer; Vital; Berlin-Chemie; Boehringer Ingelheim; Bristol-Myers Squibb; Chordate Medical; Coherex Medical; CoLucid Pharmaceuticals; electroCore, LLC; GlaxoSmithKline; Gru¨ nenthal; Janssen-Cilag; Labrys Biologics; Eli Lilly and Company; La Roche; 3M Medica; Medtronic; Menarini; Minster Pharmaceuticals; MSD; NeuroScore; Novartis; Johnson & Johnson; Pierre Fabre; Pfizer; Schaper and Bru¨ mmer; Sanofi; St. Jude Medical; and Weber & Weber. Dr. Diener has also received research funding from Allergan; Almirall; AstraZeneca; Bayer; electroCore, LLC; GlaxoSmithKline; Janssen-Cilag; MSD; and Pfizer. He has received additional research support from the German Research Council; the German Ministry of Education and Research; and the European Union. Dr. Diener has no ownership interests and does not own any pharmaceutical company stocks.K Solbach has received honoraria for oral presentations from Pharm-Allergan and Desitin GmbH. A Straube has received honoraria from Allergan; Berlin-Chemie; Desitin; MSD; Pfizer; electroCore, LLC; Boehringer Ingelheim; and St. Jude Medical. He has also received grants from the German Science Council; the German Secretary of Education; the Else Kro¨ ner-Fresenius Foundation; and the University of Munich. E Liebler is an employee of electroCore, LLC, and receives stock ownership. J Marin has received honoraria and travel grants from electroCore, LLC. MD Ferrari has received consultancy fees from Medtronic and research support from the Netherlands Organization for Scientific Research (NWO); the European Community; ZonMw; and the Dutch Heart Foundation. Dr. Ferrari is a member of the Editorial Board for Cephalalgia.
Goadsby PJ, de Coo IF, Silver N, et al. Non-invasive vagus nerve stimulation for the acute treatment of episodic and chronic cluster headache: a randomized, double-blind, sham-controlled ACT2 study [published online December 12, 2017]. Cephalalgia. doi:10.1177/0333102417744362