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Neurological Sciences
Published in: Neurological Sciences 1/2017

01-05-2017 | BRIEF COMMUNICATION

Transcutaneous supraorbital neurostimulation for the prevention of chronic migraine: a prospective, open-label preliminary trial

Authors: Paola Di Fiore, Gennaro Bussone, Alberto Galli, Henri Didier, Cesare Peccarisi, Domenico D’Amico, Fabio Frediani

Published in: Neurological Sciences | Special Issue 1/2017

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Abstract

Since chronic migraine is difficult to treat and often associated with medication overuse, non-invasive neurostimulation approaches are worth investigating. Transcutaneous supraorbital neurostimulation using the Cefaly® device is promising as a non-invasive preventive treatment for episodic migraine, but no data are available for chronic migraine. Our aim was to perform a preliminary evaluation of the efficacy of the Cefaly® device for the prophylaxis of chronic migraine with or without medication overuse. Primary endpoints were 50% reduction in monthly migraine days and 50% reduction in monthly medication use over 4 months. In an open-label study, twenty-three consecutive headache center patients with chronic migraine, diagnosed according to International Headache Society criteria, were recruited prospectively. After informed consent, patients were trained to use Cefaly® and instructed to use it for 20 min daily over 4 months. All patients received active neurostimulation. Thirty-five percent of the patients enrolled in the study achieved the study endpoints. Over half the patients had a greater than 50% reduction in acute medication consumption.
Literature
1.
Natoli J, Manack A, Dean B et al (2010) Global prevalence of chronic migraine: a systematic review. Cephalalgia 30:599–609CrossRefPubMed
2.
Evers S, Marziniak M (2010) Clinical features, pathophysiology, and treatment of medication-overuse headache. Lancet Neurol 9:391–401CrossRefPubMed
3.
D’Amico D, Grazzi L, Usai S et al (2011) Disability in chronic daily headache: state of the art and future directions. Neurol Sci 32:S71–S76CrossRefPubMed
4.
Manack AN, Buse DC, Lipton RB (2011) Chronic migraine: epidemiology and disease burden. Curr Pain Headache Rep 15:70–78CrossRefPubMed
5.
Jürgens TP, Leone M (2013) Pearls and pitfalls: neurostimulation in headache. Cephalalgia 33:512–525CrossRefPubMed
6.
Magis D, Schoenen J (2012) Advances and challenges in neurostimulation for headaches. Lancet Neurol 11:708–719CrossRefPubMed
7.
Magis D, Jensen R, Schoenen J (2012) Neurostimulation therapies for primary headache disorders: present and future. Curr Opin Neurol 25:269–276CrossRefPubMed
8.
Gallagher RM, Kunkel R (2003) Migraine medication attributes important for patient compliance: concerns about side effects may delay treatment. Headache 43:36–43CrossRefPubMed
9.
Schoenen J, Vandersmissen B, Jeangette S et al (2012) Migraine prevention with a supraorbital transcutaneous stimulator: a randomized controlled trial. Neurology 80:697–704CrossRef
10.
Headache Classification Committee of the International Headache Society (IHS) (2013) The international classification of headache disorders, 3rd edition (beta version). Cephalalgia 33(9):629-808. doi:10.​1177/​0333102413485658​ CrossRef
11.
D’Amico D, Leone M, Grazzi L et al (2008) When should “chronic migraine” patients be considered “refractory” to pharmacological prophylaxis? Neurol Sci 29:S55–S58CrossRefPubMed
12.
Mathew NT (2009) Dynamic optimization of chronic migraine treatment: current and future options. Neurology 72:S14–S20CrossRefPubMed
13.
Andrasik F, Grazzi L, Usai S et al (2007) Disability in chronic migraine with medication overuse: treatment effects at 3 years. Headache 47:1277–1281CrossRefPubMed
14.
Zwart JA, Dyb G, Hagen K et al (2003) Analgesic use: a predictor of chronic pain and medication overuse headache: the Head-HUNT study. Neurology 61:160–164CrossRefPubMed
15.
Katsarava Z, Schneeweiss S, Kurth T et al (2004) Incidence and predictors for chronicity of headache in patients with episodic migraine. Neurology 62:788–790CrossRefPubMed
16.
Bigal ME, Lipton RB (2009) What predicts the change from episodic to chronic migraine? Curr Opin Neurol 22:269–276CrossRefPubMed
17.
Katsarava Z, Muessig M, Dzagnidze A et al (2005) Medication overuse headache: rates and predictors for relapse in a 4-year prospective study. Cephalalgia 25:12–15CrossRefPubMed
18.
Bigal ME, Serrano D, Buse D et al (2008) Acute migraine medications and evolution from episodic to chronic migraine: a longitudinal population-based study. Headache 48:1157–1168CrossRefPubMed
19.
Bigal ME, Rapoport AM, Sheftell FD et al (2004) Transformed migraine and medication overuse in a tertiary headache centre-clinical characteristics and treatment outcomes. Cephalalgia 24:483–490CrossRefPubMed
20.
Freitag FG, Lake A 3rd, Lipton R, US Headache Guidelines Consortium, Section on Inpatient Treatment Chairpersons et al (2004) Inpatient treatment of headache: an evidence-based assessment. Headache 44:342–360CrossRefPubMed
21.
Zeeberg P, Olesen J, Jensen R (2006) Discontinuation of medication overuse in headache patients: recovery of therapeutic responsiveness. Cephalalgia 26:1192–1198CrossRefPubMed
22.
Saper JR, Lake AE 3rd, Cantrell DT et al (2002) Chronic daily headache prophylaxis with tizanidine: a doubleblind, placebo-controlled, multicenter outcome study. Headache 42:470–482CrossRefPubMed
23.
Spira PJ, Beran RG, Australian Gabapentin Chronic Daily Headache Group (2003) Gabapentin in the prophylaxis of chronic daily headache: a randomized, placebo-controlled study. Neurology 61:1753–1759CrossRefPubMed
24.
25.
Mei D, Ferraro D, Zelano G et al (2006) Topiramate and triptans revert chronic migraine with medication overuse to episodic migraine. Clin Neuropharmacol 29:269–275CrossRefPubMed
26.
Silvestrini M, Bartolini M, Coccia M et al (2003) Topiramate in the treatment of chronic migraine. Cephalalgia 23:820–824CrossRefPubMed
27.
Diener HC, Bussone G, Van Oene JC, TOPMAT-MIG-201(TOP-CHROME) Study Group et al (2007) Topiramate reduces headache days in chronic migraine: a randomized, double-blind, placebo-controlled study. Cephalalgia 27:814–823CrossRefPubMed
28.
Silberstein S, Lipton RB, Dodick DW et al (2007) Efficacy and safety of topiramate in the treatment of chronic migraine: a randomized, double-blind, placebo-controlled trial. Headache 47:170–180CrossRefPubMed
29.
Silberstein SD, Blumenfeld AM, Cady RK et al (2013) OnabotulinumtoxinA for treatment of chronic migraine: PREEMPT 24-week pooled subgroup analysis of patients who had acute headache medication overuse at baseline. J Neurol Sci 331:48–56CrossRefPubMed
30.
Dodick DW, Turkel CC, DeGryse RE, PREEMPT Chronic Migraine Study Group et al (2010) OnabotulinumtoxinA for treatment of chronic migraine: pooled results from the double-blind, randomized, placebo-controlled phases of the PREEMPT clinical program. Headache 50:921–936CrossRefPubMed
31.
Aurora SK, Dodick DW, Turkel CC, PREEMPT 1 Chronic Migraine Study Group et al (2010) OnabotulinumtoxinA for treatment of chronic migraine: results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 1 trial. Cephalalgia 30:793–803CrossRefPubMed
32.
Diener HC, Dodick DW, Aurora SK, PREEMPT 2 Chronic Migraine Study Group et al (2010) OnabotulinumtoxinA for treatment of chronic migraine: results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 2 trial. Cephalalgia 30:804–814CrossRefPubMed
33.
Leone M, Franzini A, Bussone G (2001) Stereotactic stimulation of posterior hypothalamic gray matter in a patient with intractable cluster headache. N Engl J Med 345:1428–1429CrossRefPubMed
34.
Lambru G, Matharu MS (2014) Peripheral neurostimulation in primary headaches. Neurol Sci 35:77–81CrossRefPubMed
35.
Saper JR, Dodick DW, Silberstein SD et al (2011) Occipital nerve stimulation for the treatment of intractable chronic migraine headache: ONSTIM feasibility study. Cephalalgia 31:271–285CrossRefPubMedPubMedCentral
36.
Bartsch T, Paemeleire K, Goadsby PJ (2009) Neurostimulation approaches to primary headache disorders. Curr Opin Neurol 22:262–268CrossRefPubMed
37.
Popeney CA, Alo´ KM (2003) Peripheral neurostimulation for the treatment of chronic, disabling transformed migraine. Headache 43:369–375CrossRefPubMed
38.
Dodick DW, Silberstein SD, Reed KL et al (2015) Safety and efficacy of peripheral nerve stimulation of the occipital nerves for the management of chronic migraine: long-term results from a randomized, multicenter, double-blinded, controlled study. Cephalalgia 35:344–358CrossRefPubMed
39.
Tepper SJ, Rezai A, Narouze S et al (2009) Acute treatment of intractable migraine with sphenopalatine ganglion electrical stimulation. Headache 49:983–989CrossRefPubMed
40.
Noseda R, Burstein R (2013) Migraine pathophysiology: anatomy of the trigeminovascular pathway and associated neurological symptoms, cortical spreading depression, sensitization, and modulation of pain. Pain 154:S44–S53CrossRefPubMed
41.
Bartsch T, Goadsby PJ (2003) The trigeminocervical complex and migraine: current concepts and synthesis. Curr Pain Headache Rep 7:371–376CrossRefPubMed
42.
Matharu MS, Bartsch T, Ward N et al (2004) Central neuromodulation in chronic migraine patients with suboccipital stimulators: a PET study. Brain 127:220–230CrossRefPubMed
43.
D’Amico D (2010) Pharmacological prophylaxis of chronic migraine: a review of double-blind placebo-controlled trials. Neurol Sci 31:S23–S28 (369–375) CrossRefPubMed
Metadata
Title
Transcutaneous supraorbital neurostimulation for the prevention of chronic migraine: a prospective, open-label preliminary trial
Authors
Paola Di Fiore
Gennaro Bussone
Alberto Galli
Henri Didier
Cesare Peccarisi
Domenico D’Amico
Fabio Frediani
Publication date
01-05-2017
Publisher
Springer Milan
Published in
Neurological Sciences / Issue Special Issue 1/2017
Print ISSN: 1590-1874
Electronic ISSN: 1590-3478
DOI
https://doi.org/10.1007/s10072-017-2916-7

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