Physician Information

A Revolution In Migraine Treatment…

In August of 2012 we received our Canadian Class II Medical Device License  (MDL#89472) for the gammaCore® non-invasive Vagus Nerve Stimulator (nVNS).  Per the original MDL gammaCore was indicated for treatment of episodic and chronic cluster headaches.  In March of 2013 this license was amended as follows: ‘The gammaCore® device is intended for non-invasive stimulation of the vagus nerve in the neck. gammaCore is indicated for the acute and/or prophylactic treatment of Cluster Headache and for the treatment of Migraines in adults.’

gammaCore® therapy is the first of its kind: a non-invasive vagus nerve stimulator that uses proprietary electrical signals to treat cluster headaches and migraines.

Early clinical use suggests that gammaCore therapy may provide the following benefits;

  • Immediate Pain Relief: Rapid relief from Cluster Headaches and Migraines
  • Prophylaxis Against Cluster Headache and Migraine
  • Incidence: Daily use may reduce the frequency, duration and severity of Cluster Headaches and Migraines
  • Minimal Side Effects: Not associated with the side effects of analgesics and narcotic medications
  • Improve Quality of Life: Can leave the patient productive and ready to restart their life

Neuro-stimulation and Cluster and Migraine Headaches

In recent years, the application of neuro-stimulation to treat headache disorders has shown promise. Several publications show a clear association between the treatment of migraine and cluster headache and implanted vagus nerve stimulation (VNS), reporting that migraineurs experience a reduction in the frequency and severity of their headaches.(1)  Additional studies have evaluated the safety and efficacy of neuro-stimulation in drug-resistant chronic-headache syndromes suggesting that “neuro-stimulation can have an effect even decades after onset of headaches, offering a possible therapeutic option in patients that do not respond to any medication.”(2)

While implanted VNS technology appears to be a practical and promising tool to treat Cluster headaches and Migraine headaches, there has been an unmet need for a non-invasive device.

How It Works

The gammaCore therapy is administered with a multi-use, hand-held battery operated portable device that transmits a proprietary electrical signal intended to provide a localized oscillating electric field in the vicinity of the vagus nerve.  The device is intended for patient purchase and use.

To prevent and/or treat cluster headaches and migraines, the gammaCore device is placed over the vagus nerve on the either side of the neck (between the trachea and the sternocleidomastoid muscle and over the carotid artery), at the location where the person’s pulse is found.

The stimulation intensity is controlled by the operator.  Each stimulation lasts for 120 seconds.  Each treatment may require multiple stimulations. The strength of the stimulation is significantly lower than that required to activate efferent vagus nerve stimulation that mediates cardiac specific effects.  Per the current gammaCore Suggested Treatment Regimen, it is recommended that the physician determine the optimal treatment for each individual patient as results may vary depending on an individual patient’s disorder and symptoms.

Click here for more more information on pre-clinical and clinical studies.

Sources
  • 1) Cecchini, A.P.; Mea, E.; Tullo, V.; Curone, M.; Franzini, A.; Broggi, G.; Savino, M.; Bussone, G.; Leone, M. Vagus nerve stimulation in drug-resistant daily chronic migraine with depression: preliminary data. Neurol Sci. 2009 May; 30 Suppl 1:S101-4. Lenaerts, M.E.; Oommen, K.J.; Couch, J.R.; Skaggs, V. Can vagus nerve stimulation help migraine? Cephalalgia. 2008 Apr; 28(4):392-5. Mauskop, A. Vagus nerve stimulation relieves chronic refractory migraine and cluster headaches. Cephalalgia. 2005 Feb; 25(2):82-6.
  • 2) Hord, E.D.; Evans, M.S.; Muueed, S.; Adamolekun, B.; Naritoku, D.K. The effect of vagus nerve stimulation on migraines. J Pain. 2003 Nov; 4(9):530-4. Sadler, R.M.; Purdy, R.A.; Rahey, S. Vagal nerve stimulation aborts migraine in patient with intractable epilepsy. Cephalalgia. 2002 Jul; 22(6):482-4. 2 Bartsch, T.; Paemeleire, K.; Goadsby, P.J. Neurostimulation approaches to primary headache disorders. Curr Opin Neurol. 2009 Jun; 22(3); 262-8.