Significant Relief of Headache Pain Following 60-Day PNS: Three-Month Outcomes From a Prospective, Single-Arm Study
N Kissoon, MD1; GG Gutierrez, MD2, ZL McCormick, MD3; M Engle, MD4; C Gilmore, MD5, M Pingree, MD1; J Pope, MD6; D DiBenedetto, MD7; P Sayal, MD4; WJ Huffman, PhD8; CA Zurn, MS8; ND Crosby, PhD8; JW Boggs, PhD8
1Mayo Clinic, Rochester, MN; 2Pain Specialists of America, Austin, TX; 3University of Utah School of Medicine, Salt Lake City, UT; 4Institute of Precision Pain Medicine, Corpus Christi, TX;5Center for Clinical Research, Winston-Salem, NC; 6Evolve Restorative Center, Santa Rosa, CA; 7MedVadis Research, Waltham, MA; 8SPR Therapeutics, Cleveland, OH
Introduction
•Background: Occipital head pain, including cervicogenic headache (CGH) and occipital neuralgia (ON), is estimated to affect over 15-20% of patients with chronic headaches.1
•60-day peripheral nerve stimulation (PNS) treatment has shown positive results for the treatment of various pain conditions, including following stimulation of the occipital nerves.2,3
•This study is the first prospective evaluation of 60-day PNS for headache pain.
•Objectives: Collect data on the safety and efficacy of 60-day PNS targeting the greater occipital nerve (GON) and third occipital nerve (TON) for the treatment of CGH and ON.
Methods
•This study is an IRB-approved, multicenter, prospective case series (n=20).
•Key eligibility criteria: occipital head pain due to CGH and/or ON, baseline average pain and pain interference ≥4/10, lack of migraine-like features, Beck Depression Inventory ≤20.
•Percutaneous leads targeting GON and TON at the C2 vertebral level were placed percutaneously for 8 weeks, up to 60 days.
•Proportion of subjects with ≥30% and ≥50% reductions in average pain intensity and/or pain interference evaluated at end of treatment (EOT) and 3 months.
•Additional outcomes: Patient Global Impression of Change (PGIC), Headache Impact Test (HIT-6), Neck Disability Index (NDI).
•EOT and 3-month data for all subjects are presented. Prospective follow up through 24 months is ongoing.
Results/Conclusions
•60-day PNS may safely and effectively relieve pain due to occipital neuralgia and/or cervicogenic headache, resulting in functional improvements and reduced the impact of headache pain and neck disability.
•Subjects experienced substantial headache pain relief and reductions in pain interference, headache impact, and pain-related neck disability.
•Prospective follow-up is ongoing, and preliminary outcomes to-date show sustained reductions in pain and pain interference in a majority of subjects.
