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In a poster presented at the CONy[1] meeting in Istanbul, by Dr. Alan Rapoport of the David Geffen School of Medicine at UCLA, the rapidly advancing field of neuromodulation was reviewed for its promise as a possible treatment for both migraine and cluster headaches.
The poster reviewed two trials which involved the use of this new therapy; a cluster headache trial with 14 patients which was an open label trial carried out at The Royal Free Clinic in London with participation of Beaumont Hospital in Dublin; and an acute migraine study, the first US FDA approved study using non invasive vagus nerve stimulation.
The open label cluster headache trial reported that 93% of the patients recorded an improvement in overall condition and an open label migraine trial of 30 patients where 42% of the patients with moderate/severe episodes reported pain relief.[2,3] These promising results were from a new non-invasive vagus nerve stimulation therapy developed by electroceutical healthcare company electroCore®.
The acute migraine study, conducted in the US, included 30 subjects who were instructed to treat up to four migraine headaches each over a six-week period. The subjects were asked to treat the migraines once the pain level had reached a moderate or severe level and within 20 minutes after the onset of pain. The treatment consisted of a 90 second stimulation dose followed by a second 90 second stimulation dose 15 minutes later.
In this trial, conducted at four sites in the United States, and recently presented at the 65th Annual American Academy of Neurology meeting, 42% of the patients (n=30) with moderate/severe episodes reported pain relief.
The cluster headache study involving 14 medically intractable patients found that 13 out of the 14 (93%) reported improvement in overall condition with one patient’s condition remaining unchanged. Twelve out of the 14 were able to reduce or cease their use of other acute medications.
ElectroCore’s non-invasive, medical treatment delivers proprietary electrical signals to stimulate the vagus nerve, likely causing the release of inhibitory neurotransmitters in the brain, including GABA, serotonin and norepinephirine. These neurotransmitters are believed to play a pivotal role in a wide range of neurological conditions including migraine and cluster headache.
ElectroCore’s gammaCore® device which delivers the small electrical current to stimulate the vagus nerve has regulatory approval in the European Union, South Africa, India, New Zealand, Australia, Colombia, Brazil, and Malaysia for the acute and/or preventative treatment of migraine, cluster headache and medication overuse headache; in Canada it has regulatory approval for the treatment and prevention of cluster headache and for the treatment of migraines. The product is now launching through healthcare professionals in Canada, Germany, UK, and other parts of Europe. Launches in other markets are planned during 2013/4. In the US FDA approved trials are continuing with a PMA approval being sought in 2014.
Vagus nerve stimulation has been used effectively for many years but has required costly, invasive procedures with an associated morbidity.
Dr Rapoport commented, “Although early, the initial data suggests possible benefit in both acute migraine and cluster headache. The adverse effects were primarily mild and transient. The further development of non invasive neurostimulation should be a priority and could provide a non-drug treatment that could help patients with these very debilitating conditions.”
Reference
- 7thWorld Congress on Controversies in Neurology (CONy), Istanbul April 11-14th, 2013
- Nesbitt , AD. et al., Non-invasive vagus nerve stimulation for the treatment of cluster headache: a case series. The Journal of Headache and Pain 2013,1(Suppl 1):P231.
- Goadsby P., Non Invasive Vagus Nerve Stimulation (nVNS) for Acute Treatment of Migraine: An Open‐Label Pilot Study. American Academy of Neurology’s 65th AAN Annual Meeting, San Diego, California, USA.
