A multicenter, prospective, single-arm study of 60-day peripheral nerve stimulation of the occipital nerves for the treatment of headache

Abstract

Objective: The aim of this study was to evaluate the efficacy and safety of a 60-day peripheral nerve stimulation (PNS) treatment targeting the occipital nerves for reducing pain and improving function in individuals diagnosed with cervicogenic headache or occipital neuralgia.

Background: Headache conditions are prevalent and commonly disabling, and conventional therapeutic strategies are often insufficient. Development of a percutaneous 60-day PNS treatment has created new opportunities to evaluate PNS of the occipital nerves.

Methods: This study was an institutional review board-approved, multicenter, prospective, single-arm study that enrolled participants from October 2022 to March 2024. Participants with cervicogenic headache or occipital neuralgia received a 60-day PNS treatment targeting the occipital nerves. The primary endpoint was the proportion reporting clinically significant (≥30%) reductions in average pain and/or pain interference at end of treatment (EOT). Additional analysis included the proportion of participants with ≥50% reduction in average pain intensity and/or pain interference and additional outcomes including Patient Global Impression of Change, six-item Headache Impact Test, and Neck Disability Index.

Results: At EOT, 90% of participants (18/20) met the primary endpoint. Further, 85% (17/20) and 83% (15/18) reported ≥50% reductions in pain and/or pain interference at EOT and 3 months, respectively. Clinically meaningful improvements were observed in functional and headache-related disability and quality-of-life measures. All study-related adverse events were non-serious.

Conclusion: Most participants reported significant reductions in pain and/or pain interference following 60-day PNS targeting the occipital nerves. Outcomes through 3 months demonstrate how 60-day PNS offers an effective approach for the treatment of headache.

Trial registration: ClinicalTrials.gov NCT05491915.

Keywords: 60‐day PNS; cervicogenic headache; headache; occipital nerves; occipital neuralgia; peripheral nerve stimulation.