Non-Invasive Vagus Nerve Stimulation in Cluster Headache: A Clinical Practice Guideline.

BACKGROUND: Cluster headache (CH) is a rare but severe primary headache disorder characterized by recurrent attacks of unilateral, typically periocular pain lasting 15 min to 3 h, accompanied by ipsilateral autonomic symptoms and restlessness or agitation. Attacks may occur multiple times daily and present in clusters lasting weeks to months, interspersed with remission periods in episodic CH, or without remission in chronic CH. METHODS: This review summarizes the clinical evidence supporting the use of transcutaneous cervical vagus nerve stimulation (tcVNS) for both the acute and preventive treatment of CH. Relevant clinical trials, real-world studies, and guideline recommendations are discussed. RESULTS: Pharmacological therapy for CH includes triptans and high-flow oxygen for acute management, and verapamil, corticosteroids, or galcanezumab for prevention. For patients with inadequate response or intolerance to these options, neuromodulation may be required. TcVNS has emerged as a noninvasive, safe, and effective alternative to invasive neuromodulation. Clinical trials have demonstrated significant reductions in attack frequency and intensity, leading to U.S. Food and Drug Administration (FDA) clearance and UK National Institute for Health and Care Excellence (NICE) approval for both acute and preventive treatment of CH. CONCLUSIONS: TcVNS represents a well-tolerated, noninvasive neuromodulatory option for patients with cluster headache, offering both acute and preventive benefits. This paper provides an overview of the current evidence, mechanisms of action, and practical guidelines for incorporating tcVNS into clinical management.