First Prospective Registry Shows Efficacy of Neuromodulation of the Sphenopalatine Ganglion for Treating Cluster Headache

Thursday, January 25, 2018


On January 25, 2018, The Journal of Headache and Pain published one-year results from an open-label registry trial, Pathway R-1, evaluating the efficacy of sphenopalatine-ganglion stimulation (SPGs) (Pulsante, Autonomic Technologies) for the treatment of both chronic and episodic cluster headache. 

Over a full 12 months, 85 patients with cluster headache (78 chronic and 7 episodic) were followed, and 68% of patients had a significant reduction in the frequency of cluster-headache attacks and/or achieved pain relief in most cluster-headache attacks. Patients experienced, on average, 42.9% fewer cluster headaches at 12 months (P < .0001, n = 85) than their baseline number of attacks before starting SPGs. This reduction was seen mostly in the first few months and was sustained through the full year. Patients also reported improvement in quality of life, reduced disability, and less medication use. Altogether, these patients used SPGs to treat 13,600 cluster headache attacks acutely. 

SPGs stimulates the sphenopalatine ganglion (SPG), a nerve bundle behind the nose. The Pulsante SPG microstimulator is a miniaturized wireless device implanted above the upper jaw. Patients control the stimulator with an external remote control that they hold next to their cheek to provide on-demand therapy of acute headache attacks. Upon pain relief, the patient moves the controller away from their cheek to stop therapy. Implantation is done in an oral procedure of 60 to 90 minutes, which leaves no visible scar. Therapy is customized for each patient during follow up visits. 

Patients experienced mild to moderate side effects similar to those seen in the Pathway CH-1 trial, which generally resolved within a few months. Side effects were similar to those of other orofacial procedures. Overall patient satisfaction was high with 86% of patients in the study stating they would recommend SPGs to others with cluster headache. 

“This study’s results are very encouraging because they reinforce clinical results seen in earlier cluster headache studies with SPG stimulation and demonstrate the therapy’s effectiveness in patients suffering from the burden and pain of cluster attacks,” said Niamh Pellegrini, President and CEO of Autonomic Technologies.

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