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SYMPOSIUM: PERIPHERAL NEUROMODULATION IN CHRONIC MIGRAINE. Peripheral neuromodulation in chronic migraine. F. Perini • A. De Boni.
Neurol Sci (2012) 33 (Suppl 1):S29–S31 DOI 10.1007/s10072-012-1039-4

SYMPOSIUM: PERIPHERAL NEUROMODULATION IN CHRONIC MIGRAINE

Peripheral neuromodulation in chronic migraine F. Perini • A. De Boni

Ó Springer-Verlag 2012

Abstract Patients with chronic migraines are often refractory to medical treatment. Therefore, they might need other strategies to modulate their pain, according to their level of disability. Neuromodulation can be achieved with several tools: meditation, biofeedback, physical therapy, drugs and electric neurostimulation (ENS). ENS can be applied to the central nervous system (brain and spinal cord), either invasively (cortical or deep brain) or non-invasively [cranial electrotherapy stimulation, transcranial direct current stimulation and transcranial magnetic stimulation]. Among chronic primary headaches, cluster headaches are most often treated either through deep brain stimulation or occipital nerve stimulation because there is a high level of disability related to this condition. ENS, employed through several modalities such as transcutaneous electrical nerve stimulation, interferential currents and pulsed radiofrequency, has been applied to the peripheral nervous system at several sites. We briefly review the indications for the use of peripheral ENS at the site of the occipital nerves for the treatment of chronic migraine. Keywords Chronic  Migraine  Peripheral  Nerve  Stimulation

Introduction Patients with chronic daily headaches and chronic migraines (CM) report remarkable impacts on everyday

F. Perini (&)  A. De Boni Headache Center, St. Bortolo Hospital, Vicenza, Italy e-mail: [email protected]

functioning and show high disability scores [1]. CM is a disabling condition prevalent in around the 2 % of population [2] and it includes transformed migraines that are considered as a migraine complication [3]. Several papers have addressed the definition of intractable headaches using specific criteria for severity of disability and pharmacological treatment failures [4–6]. However, there are no prospective trials validating the definition of refractory migraine (RM). The proportion of patients with RM attending headache treatment units is 5.1 % with a mean MIDAS score of 96; almost 40 % of these patients experience medication overuse [7]. Therefore, a huge population of patients could theoretically be candidates for an invasive procedure to reduce the pain associated with this disabling condition. More recently, Silberstein et al. proposed four classes (mild, moderate, severe and very severe) of intractability based on patients’ responses to preventive treatments. Class 3, severe, is the failure to adequately respond to treatment trials of three different drugs [e.g. b-blockers, tricyclic antidepressants, calcium antagonist (verapamil or flunarizine), sodium valproate, topiramate and combination therapy]. The definition of class 4, very severe, includes the class 3 and the failure to respond to aggressive infusion or inpatient treatment and/ or the failure to respond to detoxification treatment in subjects with medication overuse [8]. Electric nerve stimulation (ENS) is a familiar concept in the pain research field appearing in the Medline for the first time in 1948 [9]. For a detailed review exploring the pathophysiology of intrinsic head pain, the functional relationship of central and peripheral structures and theoretical mechanisms of neurostimulation, we suggest the review of Jenkins et al. [10]. We center our attention on the peripheral stimulation technique at the site of the occipital nerves for the treatment of CM.

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Table 1 Authors diagnosis

Disability measure

O.N.B. positive

Refractory

MOH

N

Efficacy

Adverse events

Device

Follow up

Popeney [12]

Yes



‘‘Refractory to conventional treatment for at least 6 months’’

76 %

25

88 % had C50 % decreased frequency or severity

36 % had lead migration 12 % had infection

Medtronic synergy

18.3 m

Yes



‘‘Failure of several preventive drugs either alone or combined’’

No

8

50 % had C50 % decreased severity

100 % had lead migration at 3 years

Medtronic synergy

19 m

No



Not reported

Not reported

3

2/3 excellent

None

BionÒ microstimulator

6m

Yes

Yes

‘‘Failure to preventative medications from at least two different classes of drugs’’

No

29

39 % had [50 % decreased frequency [50 % or a decreased severity over 3 points

24 % had lead migration/14 % had infection

Medtronic synergy

3m

Yes

No

‘‘Failure to preventative medications from at least two different classes of drugs’’

Not reported

105

53 % good or excellent open 65 % good or excellent

19 % had lead migration or malfunction or breakage 12 % infection erosion site complication

St. Jude device

3m

Episodic and transformed migraine Schwedt [13] CM

Trentman [14] CM Saper [10] CM

Silberstein [15] CM Probable CM

Methods We performed a Medline search using the following keywords: chronic, migraine, peripheral, nerve and stimulation.

Results The search engine retrieved 47 papers. According to our aim, we selected one randomized trial [11]. Furthermore, we performed a search inquiry using the word ‘headache’ instead of ‘migraine’ and we selected the other three nonrandomized trials [12–14]. Data regarding a second randomized controlled trial presented at Berlin HIS congress in 2011 were added [15]. Results are summarized in the Table 1.

Conclusion Globally 170 CM patients were treated with occipital nerve stimulation (ONS) in CM. Despite the methodological differences, it seems to be a promising therapy. However, the use of ONS requires careful and accurate selection of

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patients due to the high cost of the device and the frequent occurrence of lead migration, which can lead to additional surgeries. The proposed definition of severe intractability (Class III) paired with moderate disability scores [8] could be too broad a definition to qualify patients for ONS invasive treatment. Only patients with high disability score and failure to all different classes of preventive treatment [16] should be candidates for invasive procedure. There is a need for future studies using ONS on Class 4 CM patients who experience severe disabilities and are unresponsive to preventive treatments. Conflict of interest The authors certify that there is no actual or potential conflict of interest in relation to this article.

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neuromodulation in primary headaches. Headache 51(8): 1254–1266 Review Saper JR, Dodick DW, Silberstein SD, McCarville S, Sun M, Goadsby PJ, ONSTIM Investigators (2011) Occipital nerve stimulation for the treatment of intractable chronic migraine headache: ONSTIM feasibility study. Cephalalgia 31(3):271–285 Popeney C, Alo K (2003) Peripheral neurostimulation for the treatment of chronic, disabling transformed migraine. Headache 43:369–375 Schwedt TJ, Dodick DW, Hentz J, Trentman TL, Zimmerman RS (2007) Occipital nerve stimulation for chronic headache—longterm safety and efficacy. Cephalalgia 27:153–157 Trentman TL, Rosenfeld DM, Vargas BB, Schwedt TJ, Zimmerman RS, Dodick DW (2009) Greater occipital nerve stimulation via the Bion microstimulator: implantation technique and stimulation parameters. Clinical trial: NCT00205894. Pain Physician 12(3):621–628 Silberstein S, Dodick D, Saper J, Huh B et al (2011) The safety and efficacy of peripheral nerve stimulation of the occipital nerve for the management of chronic migraine. Poster presented at: 15th Congress of the International Headache Society, Berlin, 23–26 June 2011 D’Amico D, Leone M, Grazzi L, Bussone G (2008) When should ‘‘chronic migraine’’ patients be considered ‘‘refractory’’ to pharmacological to pharmacological prophylaxis? Neurol Sci 29:S55–S58

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