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doi:10.1111/j.1468-2982.2009.01996.x Combined occipital and supraorbital neurostimulation for the treatment of chronic migraine headaches: initial experienceceph_1996 1..13 KL Reed1, SB Black2, CJ Banta II3 &KRWill1 1Department of Anesthesiology, Presbyterian Hospital of Dallas, 2Medical Director of Neurology, Baylor University Medical Center of Dallas, and 3Department of Orthopedic Surgery, Presbyterian Hospital of Dallas, Dallas, TX, USA Reed KL, Black SB, Banta CJ II & Will KR. Combined occipital and supraorbital neurostimulation for the treatment of chronic migraine headaches: initial expe- rience. Cephalalgia 2009. London. ISSN 0333-1024 A novel approach to the treatment of chronic migraine headaches based on neurostimulation of both occipital and supraorbital nerves was developed and reduced to clinical practice in a series of patients with headaches unresponsive to currently available therapies. Following positive trials, seven patients with chronic migraine and refractory chronic migraine headaches had permanent combined occipital nerve–supraorbital nerve neurostimulation systems implanted. The relative responses to two stimulation programs were evaluated: one that stimulated only the occipital leads and one that stimulated both the occipital and supraorbital leads together. With follow-up ranging from 1 to 35 months all patients reported a full therapeutic response but only to combined supraorbital–occipital neurostimulation. Occipital nerve stimulation alone pro- vided a markedly inferior and inadequate response. Combined occipital nerve– supraorbital nerve neurostimulation systems may provide effective treatment for patients with chronic migraine and refractory chronic migraine headaches. For patients with chronic migraine headaches the response to combined systems appears to be substantially better than occipital nerve stimulation alone. ᮀMigraine, chronic migraine, refractory migraine, peripheral nerve stimulation, occipi- tal nerve stimulation, supraorbital nerve stimulation Kenneth L. Reed MD, 8220 Walnut Hill Lane, Suite 202, Dallas, TX 75231, USA. Tel. + 1-214-345-5656, fax + 1-214-345-5698, e-mail [email protected] Received 24 March 2009, accepted 26 July 2009 of studies on cephalic neuralgias were consistent Introduction with the well-documented effectiveness of Following our initial report in 1999 on occipital implanted neurostimulation for neuropathic pain nerve stimulation (ONS) treatment for refractory syndromes over the rest of the body, including the occipital neuralgia (1), the development of torso and limbs. Indeed, neuropathic pain remains peripheral nerve stimulation (PNS) for head pain possibly the best documented indication for has proceeded along two general diagnostic implantable neurostimulators, regardless of ana- avenues: certain cephalic neuralgias (occipital tomical location (10). neuralgia and certain trigeminal neuralgias) and As the evidence base for PNS in the treatment of the distinct, more general primary headache syn- cephalic neuralgias has increased, attention has dromes. Regarding the cephalic neuralgias, numer- shifted to its potential in treating primary and ous subsequent investigators have supported our secondary headaches. In 2003, Popeney and Alo initial findings for occipital neuralgia (2–6), whereas observed strongly positive responses in a series of others have successfully extended this treatment patients with headaches with migrainous symp- methodology to the frontal region and various toms (11), and Dodick observed a similar response trigeminal neuralgias (7–9). Importantly, the results in a patient with cluster headaches (12). Subsequent © Blackwell Publishing Ltd Cephalalgia, 2009 1 2 KL Reed et al. investigations have reported that various headache localized to the lumbar region. However, that is syndromes responded variably to ONS, with the indeed what is being suggested for certain head- majority of studies involving three general diagnos- ache types and is thus a relevant concern, as several tic categories: occipito-cervical headaches (3, 7, studies have reported improvements in patients 13, 14), cluster headaches (15–21) and chronic with holocephalic/hemicranial migraine and migraines (22–25). Although summaries of these cluster headaches (thus a fronto-temporal distribu- studies reveal a consistently high (average 88%) tion of pain) by stimulating the anatomically distant response rate for occipital neuralgia and cervico- occiput (3, 11, 12, 15–25). This methodology of genic headaches, they indicate only roughly a treating distant pain, outside of the distribution 40–50% rate for primary migraines and cluster of the stimulated nerve, is therefore novel; however, headaches (Tables 3–5), which suggests that a sub- as the clinical results are persuasive, it needs to stantial subset of patients with these types of be explained. Otherwise, the traditional clinical primary headache may indeed not respond to ONS. approach of seeking a concordant paraesthesia sug- Importantly, the historical trajectory of PNS treat- gests that combining SONS with ONS may provide ment has evolved differently over the frontal and for a better treatment response in patients with occipital regions. Over the occipital region the indi- hemicranial/holocephalic primary migraines than cations studied for ONS treatment progressed, as would be seen with ONS alone, where the paraes- noted, from solely occipital neuralgia to the more thesia would cover only the occipital portion of the general primary headaches, whereas over the pain. Or, more generally, it suggests that ONS may frontal region the indications remained largely be best for occipital pain, SONS for frontal pain and limited to various trigeminal neuralgias. While a combined ONS–SONS for holocephalic pain. report by Slavin in 2006 included headache patients Noting a subset of patients with primary treated with supraorbital nerve stimulation (SONS) migraine headaches that may be non-responsive to along with ONS (7), a corresponding effort to evalu- ONS, and based upon the historical clinical ate specifically the potential effectiveness of SONS approach of covering the painful area as best as for primary headaches was not made until 2007, possible with the paraesthesia, as well as the poten- when Narouze described a positive response in a tial neuroanatomical substrate of the TCC with its patient with cluster headaches (26). This is interest- final common pathway for both trigeminal and ing, as a consideration of the final common neu- occipital nociceptive afferents, we hypothesized roanatomical pathway for all cephalic afferents that patients with hemicranial/holocephalic, suggests potential for a salutary effect from SONS. primary migraine headaches would respond better Specifically, both the trigeminal and greater occipi- when both occipital and supraorbital stimulation tal nociceptive afferents converge on the same were applied together as opposed to occipital second-order sensory neurons in the trigeminocer- stimulation alone. We report on seven patients with vical complex (TCC), and thus on a final common severe, chronic migraine headaches (three had pathway to the higher structures, including nuclei refractory headaches) that benefited from combined felt to be important in pain modulation (27–29). ONS and SONS. This is the first report on the use Acknowledging this common neurosubstrate begs of combined frontal and occipital neurostimulation the question as to the potential effectiveness of for primary headaches. SONS as a treatment for frontal headaches analo- gous to ONS and occipital headaches. Another rationale for considering the potential Materials and methods for SONS in the treatment of headaches is based on the generally accepted clinical approach to treating Patient population pain with neurostimulation, whereby the goal is to produce a concordant paraesthesia, i.e. to cover Patients were referred by experienced neurology the painful region as best as possible with the headache specialists. Diagnoses conformed to crite- stimulator-induced paraesthesia. This is the clinical ria of the International Classification of Headache indicator that the appropriate portion of the Disorders, 2nd edn, of the International Headache nervous system is being stimulated and is the rec- Society (IHS) (31) and satisfied appendix criteria ognized approach to neurostimulation and pain for chronic migraine (32). All patients had well- over the torso and limbs (30). For example, one documented histories of severe (disabling), chronic would not generally consider treating chronic migraine headaches (Table 1). Additionally, three abdominal wall pain by an induced paraesthesia patients (cases 1, 2 and 6) satisfied Schulman’s © Blackwell Publishing Ltd Cephalalgia, 2009 Combined neurostimulation for headaches 3 proposed criteria for refractory headaches (33). The other four had headaches unresponsive to extended courses of medical management but did not strictly Functional status Impaired Incapacitated Incapacitated Limited Incapacitated Homebound meet the Schulman criteria. The headaches were either hemicranial or holocephalic in extent, having specifically no history suggesting a primary occipi- tal focus (it cannot have initiated from or be local- ized to the occiput). For the three patients with refractory headaches, the medications listed were provided at optimal dosages and over sufficient periods (over 2 months) to be consistent with the criteria for refractory headache. Several patients were taking small doses of opiates at presentation; however,

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