GammaCore nVNS Deemed Effective for Acute Treatment, Prevention of Cluster Headache

Author(s):

A recent review outlined the clinical features, pathophysiology, and treatments for cluster headache, finding noninvasive vagus nerve stimulation to be effective in various ways.

Diana Wei, MBBS

A recent review of cluster headache and its treatment elucidated key clinical features of the disease, as well as the current and emerging therapies for the disabling headache disorder.¹ Traditionally, this area of headache care has lacked effective options.

In reviewing treatments for cluster headache, the authors identified electroCore’s gammaCore therapy as the only therapy shown to be effective for both the acute treatment of episodic cluster headache as well as the prevention of cluster headache in clinical trials.

“Great strides have been made in the treatment of cluster headache in the past decade,” co-author Peter Goadsby, MD, PhD, DSc, professor of neurology, University of California, Los Angeles, said in a statement.² “Treatment options such as noninvasive vagus nerve stimulation (nVNS) may benefit individuals with cluster headache and have a substantial economic impact both directly by decreasing the overall cost of health care and indirectly by reducing absence from work and reduced work efficiency due to cluster headaches.”

Goadsby and first author Diana Wei, MBBS, PhD candidate, King’s College London, reviewed the clinical characteristics of cluster headache, including criteria for diagnosis. These criteria are as follows: at least 5 attacks of severe unilateral orbital, supraorbital and/or temporal pain that lasts 15 to 180 minutes when untreated; experiencing either a sense of restlessness or agitation; experiencing, ipsilateral to the headache, conjunctival infection and or/lacrimation, nasal congestion and/or rhinorrhea, eyelid edema, forehead and facial sweating, miosis and/or ptosis. Attacks must occur at least once every 2 days but no more than 8 times per day and there must be no better fitting International Classification of Headache Disorders (ICHD-3) diagnosis.

The authors reviewed 3 key components of cluster headaches: the trigeminovascular pathway, pivotal in severe pain in the unilateral trigeminal distribution; the trigeminal-autonomic reflex, which produces cranial autonomic symptoms; and the hypothalamus, which plays a role in the circadian and circannual pattern of attacks and likely contributes to attack generation. They also reviewed key neuropeptides such as calcitonin gene-related peptide, pituitary adenylate cyclase-activating polypeptide, nitric oxide synthase, vasoactive intestinal peptide, neuropeptide Y, acetylcholine, nitric oxide synthase, and glutamate.

The authors reviewed treatments and their performance in clinical studies and found only nVNS to be both useful for pain relief within 15 minutes in episodic cluster headache (ECH) and for reducing the number of attacks per week in chronic cluster headache (CCH) when used in addition to standard-of-care treatment. In addition to nVNS, they found other useful acute treatments, such as subcutaneous sumatriptan (6 mg), high-flow oxygen via non-rebreather mask (12 l/min for 15 min), intranasal sumatriptan (20 mg), and intranasal zolmitriptan (5 mg and 10 mg).

For interim treatments, the authors found oral prednisone (30 mg and 100 mg with tapering) and ipsilateral greater occipital nerve injection of local anesthetic or steroid to be useful. For preventive treatment, they found melatonin (10 mg) useful, verapamil (360 mg/day) and lithium (800-900 mg/day) require close monitoring, and topiramate (25-400 mg/day) was poorly tolerated with not much evidence for efficacy. In addition to nVNS, the authors found other emerging treatments such as galcanezumab (300 mg), sphenopalatine ganglion stimulation (15-min stimulation), and somatostatin receptor agonists to be useful.

“We compliment the authors on their rigorous review of current and emerging treatment options and on the publication, which highlights progress in the study of cluster headache and the evolution of its treatment. nVNS, which is unique in its ability to be used acutely or preventively by patients suffering from cluster headache, is ideally suited to help these patients manage their devastating attacks while decreasing the overall costs to healthcare systems,” added Eric Liebler, senior vice president, neurology, electroCore.²

REFERENCES

1. Wei DY, Goadsby PJ. Cluster headache pathophysiology — insights from current and emerging treatments. Nat Rev Neurol. 2021:17:308-324. doi: 10.1038/s41582-021-00477-w
2. electroCore Announces Publication in Nature Reviews: Neurology Highlighting the Role of Non-Invasive Vagus Nerve Stimulation (nVNS) as an Emerging Treatment for Cluster Headache. News release. ElectroCore. Published online April 15, 2021. https://www.globenewswire.com/news-release/2021/04/15/2210721/0/en/electroCore-Announces-Publication-in-Nature-Reviews-Neurology-Highlighting-the-Role-of-Non-Invasive-Vagus-Nerve-Stimulation-nVNS-as-an-Emerging-Treatment-for-Cluster-Headache.html