Safety and efficacy of sphenopalatine ganglion stimulation for chronic cluster headache: a double-blind, randomised controlled trial

Goadsby, PJ; Sahai‐Srivastava, Soma; Kezirian, Eric J.; Calhoun, Anne H.; Matthews, David C; McAllister, Peter; Costantino, Peter D.; Friedman, Deborah I.; Zuniga, John R.; Mechtler, Laszlo; Popat, Saurin R.; Rezai, Ali R.; Dodick, David W.

doi:10.1016/s1474-4422(19)30322-9

Cited by 59 publications

(56 citation statements)

References 45 publications

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“…In a randomized, sham-controlled, parallel-group, double-blinded study, patients who received the sphenopalatine ganglion (SPG) stimulation were more likely to achieve the primary endpoint, defined as the relief from pain within 15 min (62.5% vs. 38.9%, p = 0.008). 13 Among the 45 patients in the SPG stimulation group, nine developed serious adverse events, four of which were implantation related. The SPG stimulation seems efficacious and well tolerated for patients with chronic CH.…”

Section: Clinical Studies and Advances In Treatmentmentioning

confidence: 99%

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Headache highlights 2019: Junior editors’ choice

Peng

Chen

Gudmundsson

2020

Cephalalgia Reports

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Section: Clinical Studies and Advances In Treatmentmentioning

confidence: 99%

“…The SPG stimulation seems efficacious and well tolerated for patients with chronic CH. 13 Unfortunately, the producer of the device has filed bankruptcy and whether the device will be available again remains unknown.…”

Section: Neuromodulation On Patients With Chronic Chmentioning

confidence: 99%

Headache highlights 2019: Junior editors’ choice

Peng

Chen

Gudmundsson

2020

Cephalalgia Reports

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“…Each patient signed informed consent approved by the UTSW IRB committee (STU#052015-044). The results of this clinical trial have been previously published [16]. The sphenopalatine ganglion is located at the terminal end of the vidian canal, which contains the greater and lesser petrosal nerves that are preganglionic parasympathetic afferents synapsing in the sphenopalatine ganglion, which are shown to be involved in inducing the trigeminal autonomic reflex onset of cluster headaches [17].…”

Section: Sphenopalatine Ganglion Implantation Proceduresmentioning

confidence: 99%

Trigeminocardiac Reflex Induced by Maxillary Nerve Stimulation during Sphenopalatine Ganglion Implantation: A Case Series

et al. 2020

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Background: The trigeminocardiac reflex (TCR) is a brainstem reflex following stimulation of the trigeminal nerve, resulting in bradycardia, asystole and hypotension. It has been described in maxillofacial and craniofacial surgeries. This case series highlights TCR events occurring during sphenopalatine ganglion (SPJ) neurostimulator implantation as part of the Pathway CH-2 clinical trial “Sphenopalatine ganglion Stimulation for Treatment of Chronic Cluster Headache”. Methods: This is a case series discussing sphenopalatine ganglion neurostimulator implantation in the pterygopalatine fossa as treatment for intractable cluster headaches. Eight cases are discussed with three demonstrating TCR events. All cases received remifentanil and desflurane for anesthetic maintenance. Results: Each patient with a TCR event experienced severe bradycardia. In two cases, TCR resolved with removal of the introducer, while the third case’s TCR event resolved with both anticholinergic treatment and surgical stimulation cessation. Conclusion: Each TCR event occurred before stimulation of the fixed introducer device, suggesting the cause for the TCR events was mechanical in origin. Due to heightened concern for further TCR events, all subsequent cases had pre-anesthesia external pacing pads placed. Resolution can occur with cessation of surgical manipulation and/or anticholinergic treatment. Management of TCR events requires communication between surgical teams and anesthesia providers, especially during sphenopalatine ganglion implantation when maxillary nerve stimulation is possible.

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“…The Pathway CH-2 study [92] was a randomized controlled trial involving ninety-three chronic CH patients based in the USA, treating their attacks with either active SPG stimulation or sham. Comparing SPG-stimulated and shamstimulated attacks, patients were more often pain free at 15 min with active treatment.…”

Section: Sphenopalatine Ganglion Stimulationmentioning

confidence: 99%

“…Implantation of the sphenopalatine ganglion is an invasive procedure that can cause adverse events, comprising swelling, pain and sensory disturbances in the site of implantation. In general, these side effects are well tolerated and resolve within a few months, very rarely have they required explantation of the device [91,92].…”

Section: Sphenopalatine Ganglion Stimulationmentioning

confidence: 99%

Recent Advances in the Management of Cluster Headache

Villar-Martínez

Puledda

Goadsby

2020

Curr Treat Options Neurol

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Purpose of review Among the spectrum of pain conditions, cluster headache represents one of the most severe. Targeted therapies for cluster headache are evolving thus improving the available therapeutic armamentarium. A better understanding of the currently available therapies, as well as new and emerging options, may aide physicians to manage affected sufferers better by evolving treatment guidance. Recent findings While classic first-line medications are useful in some patients with cluster headache, they are often accompanied by significant side effects that limit their use. Recently, novel treatments with better tolerability and decreased medication interactions have proven to be effective. A remarkable example of this is the blockage of the calcitonin gene-related peptide pathway with monoclonal antibodies, which may be a key element in the future treatment of cluster headache. The sphenopalatine ganglion and vagus nerve perform a critical role in the regulation of pain and the trigeminal autonomic reflex. Neuromodulation therapies targeting these structures have shown excellent tolerability and few significant adverse events, constituting a promising form of treatment. Finally, several potential therapeutic targets are examined in this review, such as small molecule CGRP receptor antagonists, known as gepants, and serotonin receptor 5-HT1F receptor agonists: ditans. Summary In summary, a deepening of the understanding of cluster headache mechanisms in recent years has driven the evolution of sophisticated therapeutic approaches that could allow a new era in the treatment of this difficult condition.

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Safety and efficacy of sphenopalatine ganglion stimulation for chronic cluster headache: a double-blind, randomised controlled trial

Cited by 59 publications

References 45 publications

Headache highlights 2019: Junior editors’ choice

Headache highlights 2019: Junior editors’ choice

Trigeminocardiac Reflex Induced by Maxillary Nerve Stimulation during Sphenopalatine Ganglion Implantation: A Case Series

Recent Advances in the Management of Cluster Headache

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