Clinical experience with transcutaneous supraorbital nerve stimulation in patients with refractory migraine or with migraine and intolerance to topiramate: a prospective exploratory clinical study
Michail Vikelis, Emmanouil V Dermitzakis, Konstantinos C Spingos, Georgios G Vasiliadis, George S Vlachos, Evaggelia Kararizou, Michail Vikelis, Emmanouil V Dermitzakis, Konstantinos C Spingos, Georgios G Vasiliadis, George S Vlachos, Evaggelia Kararizou
Abstract
Background: Migraine is included in the top-ten disabling diseases and conditions among the Western populations. Non-invasive neurostimulation, including the Cefaly® device, for the treatment of various types of pain is a relatively new field of interest. The aim of the present study was to explore the clinical experience with Cefaly® in a cohort of migraine patients previously refractory or intolerant to topiramate prophylaxis.
Methods: A prospective, multi-center clinical study was performed in patients diagnosed with episodic or chronic migraine with a previous failure to topiramate treatment requiring prevention with Cefaly® according to the treating physician's suggestion. A 1-month period of baseline observation was followed by a 3-month period of observation during the use of transcutaneous supraorbital nerve stimulation (t-SNS) with Cefaly® as the only preventive treatment.
Results: A small but statistically significant decline was shown over time in the number of days with headache (HA), the number of days with HA with intensity ≥5/10, and the number of days with use of acute medication after 3 months (p < 0.001 for all of the three changes). Twenty-three patients (65.7%) expressed their satisfaction and intent to continue treatment with Cefaly®. Compliance was higher among satisfied subjects compared to non-satisfied subjects. None of the explored factors were significantly associated with the reason for the failure of topiramate.
Conclusion: Three-months of preventive treatment for episodic or chronic migraine with t-SNS proved to be an effective, safe and well tolerated option for the treatment of patients with migraine who were intolerant or did not respond to topiramate.
Trial registration: ClinicalTrials NCT03125525 . Registered 21 April 2017.
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References
- Global Burden of Disease Study 2013 Collaborators Global, regional, and national incidence, prevalence, and years lived with disability for 301 acute and chronic diseases and injuries in 188 countries, 1990–2013: a systematic analysis for the Global burden of disease study 2013. Lancet. 2015;386(9995):743–800. doi: 10.1016/S0140-6736(15)60692-4.
- Malik SN, Hopkins M, Young WB, Silberstein SD. Acute migraine treatment: patterns of use and satisfaction in a clinical population. Headache. 2006;46(5):773–780. doi: 10.1111/j.1526-4610.2006.00437.x.
- Steiner TJ, Paemeleire K, Jensen R, et al. European principles of management of common headache disorders in primary care. J Headache Pain. 2007;8(Suppl 1):S3–47.
- Vikelis M, Dermitzakis E, Spingos K. et al. Greek Headache Society guidelines for the treatment of migraine. . Accessed 10 May 2017.
- Mulleners WM, McCrory DC, Linde M. Antiepileptics in migraine prophylaxis: an updated Cochrane review. Cephalalgia. 2015;35(1):51–62. doi: 10.1177/0333102414534325.
- Berger A, Bloudek LM, Varon SF, Oster G. Adherence with migraine prophylaxis in clinicalpractice. Pain Pract. 2012;12:541–549. doi: 10.1111/j.1533-2500.2012.00530.x.
- Hepp Z, Bloudek LM, Varon SF. Systematic review of migraine prophylaxis adherence and persistence. J Manag Care Pharm. 2014;20(1):22–33.
- Cruccu G, Aziz TZ, Garcia-Larrea L, et al. EFNS guidelines on neurostimulation therapy for neuropathic pain. Eur J Neurol. 2007;14:952–970. doi: 10.1111/j.1468-1331.2007.01916.x.
- Moskowitz MA. The neurobiology of vascular head pain. Ann Neurol. 1984;16(2):157–168. doi: 10.1002/ana.410160202.
- Noseda R, Burstein R. Migraine pathophysiology: anatomy of the trigeminovascular pathway and associated neurological symptoms, cortical spreading depression, sensitization, and modulation of pain. Pain. 2013;154(Suppl 1):S44–S53. doi: 10.1016/j.pain.2013.07.021.
- Magis D, Sava S. D’ Elia TS et al. safety and patients’ satisfaction of transcutaneous supraorbital neurostimulation (tSNS) with the Cefaly® device in headache treatment: a survey of 2313 headache sufferers in the general population. J Headache Pain. 2013;14:95. doi: 10.1186/1129-2377-14-95.
- Cefaly® Technology. . Accessed 11 May 2017.
- Headache Classification Committee of the International Headache Society (IHS). The International Classification of headache disorders, 3rd edition (beta version). Cephalalgia 2013;33:629–808.
- Riederer F, Penning S, Schoenen J. Transcutaneous Supraorbital nerve stimulation (t-SNS) with the Cefaly® device for migraine prevention: a review of the available data. Pain Ther December 2015, Volume 4, Issue 2, pp 135–147.
- Linde M, Mulleners WM, Chronicle EP, et al. Topiramate for the prophylaxis of episodic migraine in adults. Cochrane Database Syst Rev. 2013;24(6):CD010610.
- Schoenen J, Vandersmissen B, Jeangette S, et al. Migraine prevention with a supraorbital transcutaneous stimulator: a randomized controlled trial. Neurology. 2013;80:697–704. doi: 10.1212/WNL.0b013e3182825055.
Source: PubMed