60-Day Peripheral Nerve Stimulation Provides Durable Relief from Occipital Head Pain: 12-Month Outcomes from a Prospective, Single-Arm Study

Narayan Kissoon MD1, Christopher Gilmore MD2, Zachary McCormick MD3, Genaro Gutierrez MD4, Mitchell Engle MD5, Matthew Pingree, MD1, Jason Pope MD6, David DiBenedetto MD7, William Huffman PhD8, Nathan Crosby PhD8, Joseph Boggs PhD8

1. Mayo Clinic, Rochester, MN. 2. Center for Clinical Research, Winston-Salem, NC. 3. University of Utah School of Medicine, Salt Lake City, UT. 4. Pain Specialists of America, Austin, TX. 5. Institute of Precision Pain Medicine, Corpus Christi, TX. 6. Evolve Restorative Center, Santa Rosa, CA. 7. MedVadis Research, Waltham, MA. 8. SPR, Cleveland, OH

Introduction

•Over 15% of patients with chronic headache have occipital head pain, including from cervicogenic headache (CGH) and occipital neuralgia (ON).^1,2

•CGH and ON can be significantly debilitating, impacting physical function, social function, sleep, and headache-related quality of life.

•Recently published data included evidence of pain relief in participants with CGH or ON following percutaneous 60-day peripheral nerve stimulation (PNS) through 3 months from the start of treatment.³

•Here, the study cohort is followed through 12 months to determine the sustained effects of 60-day PNS used for treatment of occipital head pain.

Methods

• IRB-approved, multicenter, prospective case series (5 sites, n=20) .

• Key eligibility criteria: occipital head pain due to CGH and/or ON, baseline average pain and pain interference ≥4/10, lack of migrainelike features, and Beck Depression Inventory ≤20.

• Flexible, percutaneous leads were placed to target the greater and third occipital nerves (e.g., at the C2 lamina) for up to 60 days.

• Participants controlled stimulation intensity using a handheld remote.

• Sustained relief is presented as the proportion of participants with ≥50% reduction in average pain intensity and/or pain interference at study visits following end of treatment (EOT) including through 12 months.

• Secondary outcomes: Patient Global Impression of Change (PGIC), Neck Disability Index (NDI), and Headache Impact Test (HIT-6).

• Missing data were addressed using multiple imputation with predictive mean matching performed by an independent third-party statistician group (WCG, Cary, NC).

Results

A majority of participants (82%) reported substantial reductions (≥50%) in average pain and/or pain interference through 12 months.

On average, participants reported sustained relief from pain and pain interference through 12 months.

A majority of participants showed clinically meaningful improvements in neck disability, headache impact, and/or quality of life through 12 months

Safety: Within this cohort, all study-related AEs were non-serious with the most common events being skin irritation from bandages and post-procedural discomfort. No new device-related adverse events were reported in the follow-up period

Conclusions

• Percutaneous 60-day PNS safely and effectively relieved occipital headache pain, and relief was sustained through 12 months in a large majority of participants.

• Pain relief facilitated improvements in multiple headache-related domains including reduced impact of head pain with daily activities, improved quality of life, and reduced neck painrelated disability.

References

1. Fabry et al., Neuroradiology 2023. 2. Robinson et al., Cephalalgia 2025. 3. Gutierrez et al., Headache 2025. 4. Vernon, J Manip Physiol Ther 2008 5. Kosinski et al. Qual Life Res 2003

Acknowledgments

This work was supported by SPR. Disclosures: CG, ZM, GG, and JP have consulted for SPR. WJH, NDC, and JWB are employees of SPR. The authors thank the site clinical coordinators and research staff for their contributions to the study. The authors are also grateful for the dedication and effort of the Clinical Affairs team at SPR, including Dana Crowe, Sara Anderson, and Rosemary Zang.