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.

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.

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.

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.

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.