Unmet treatment needs in patients suffering from cluster headache and migraine.
Cluster headaches present many treatment challenges:
- Accessibility, portability, and cost of ultra-high flow O22,3
- Limits of maximum daily dosing with triptans3
- Triptans contraindicated in pre-existing cardiac and cerebrovascular disorders4
- Approximately 20% of patients develop chronic cluster headache, with many resistant to conventional multimodal therapies5
- Invasive neurostimulation procedures are available; however, pose some risk for surgical and anesthetic complications3
- Evidence-based treatment recommendations needed4
- Cardiovascular side effect concerns with verapamil4
- Few controlled studies exist4
- Better efficacy and tolerability needed
- No major guidelines for long-term treatment4
The majority of migraineurs have at least one unmet treatment need
In the American Migraine Prevalence and Prevention Study, patients (n=5,591) with episodic migraine (<15 days/month) reported:6
Among the 40.7% of those reporting ≥1 unmet treatment need6
The limitations of current treatments highlight a clinical need for new treatment options. In recent years, the application of neurostimulation to treat headache disorders has shown promise. Several publications show a clear association between the treatment of migraine and implanted vagus nerve stimulation (VNS), reporting that migraineurs experience a reduction in the frequency and severity of their headaches.7
Additional studies have evaluated the safety and efficacy of neurostimulation and suggest “neurostimulation can have an effect even decades after onset of headaches, offering a possible therapeutic option for patients.”8
Although implanted VNS has shown promise in the treatment of migraine and cluster headache, the morbidity and inconvenience associated with the invasive implantation procedure, along with the cost of these devices, limit the potential for frequent use.9
gammaCore: bringing the clinical potential of nVNS to life
1. Oshinsky ML, Murphy AL, Hekierski H Jr., Cooper M, Simon BJ. Non-invasive vagus nerve stimulation as treatment for trigeminal allodynia. Pain (2014), doi: http://dx.doi.org/10.1016/j.pain.2014.02.009.
2. Rozen TD, Fishman RS. Inhaled oxygen and cluster headache sufferers in the United States: use, efficacy and economics: results from the United States Cluster Headache Survey. Headache. 2011;51(2):191-200.
3. Nesbitt AD, Marin JCA, Tomkins E, Rutledge MH, Goadsby PJ. Non-invasive vagus nerve stimulation for the treatment of cluster headache: a cohort series with extended follow-up. Poster presented at: International Neuromodulation Society 11th World Contress; June 12, 2013; Berlin.
4. Gaul C, Diener HC, Müller OM. Cluster headache: clinical features and therapeutic options. Dtsch Arztebl Int. 2011;108(33):543-549.
5. Rasskazoff SY, Slavin KV. Neuromodulation for cephalgias. Surg Neurol Int. 2013;4(Suppl 3):S136-S150.
6. Lipton RB, Buse DC, Serrano D, Holland S, Reed ML. Examination of unmet treatment needs among persons with episodic migraine: results of the American Migraine Prevalence and Prevention (AMPP) Study. Headache. 2013;53(8):1300-1311.
7. 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. 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.
8. ?Bartsch, T.; Paemeleire, K.; Goadsby, P.J. Neurostimulation approaches to primary headache disorders. Curr Opin Neurol. 2009 Jun; 22(3); 262-8.
9. George MS, Sackeim HA, Rush AJ, Marangell LB, Nahas Z, Husain MM, Lisanby S, Burt T, Goldman J, Ballenger JC: Vagus nerve stimulation: a new tool for brain research and therapy. Biol Psychiatry 2000; 47:287-295.