Efficacy and Safety of Magnetic Peripheral Nerve Stimulation for Treatment of Neuropathic Pain; One Year Follow Up of Long-Term Outcomes.

OBJECTIVE

Magnetic Peripheral Nerve Stimulation (mPNS) is an emerging neuromodulation therapy for chronic pain. We aimed to assess the safety and efficacy of mPNS in combination with CMM in patients with post-traumatic or post-surgical pain.

MATERIALS AND METHODS

Safety and Efficacy of Axon Therapy (SEAT) was a prospective, randomized, multi-center study conducted across four clinical sites in the United States with 1 year follow-up. Eligible participants were between 18-75 years old, had chronic neuropathic pain for at least three months, and a baseline visual analog scale (VAS) score of 6 or higher. Subjects were randomized 1:1 to receive either Magnetic Peripheral Nerve Stimulation (mPNS) along with their Conventional Medical Management (mPNS+CMM) or CMM alone. Subjects in CMM cohort were allowed to crossover at Day 90. The primary efficacy endpoint was the number of subjects with ≥50% reduction of pain intensity at Day 90 without an increase in pain medication. The primary safety endpoint was the proportion of subjects free from therapy-related adverse events at Day 90. This trial is registered with ClinicalTrials.gov, NCT04795635.

RESULTS

90 participants were screened, and 65 met the inclusion criteria to be enrolled (CMM + mPNS 35; CMM: 30). At Day 90, 71% of subjects were considered responders (>50% pain relief) in the CMM + mPNS cohort vs 13% of subjects in the CMM group (p < 0.0001). By the end of the study, 94% of participants were determined to be pain responders in the CMM + mPNS group as well as 69.2% in the Crossover group. The EQ-5D-3L and PGIC responder rates also improved. AEs were considered to be treatment-related in three (8.6%) CMM + mPNS participants, and two (10.5%) Crossover participants.

CONCLUSION

mPNS was well-tolerated and resulted in significant long-term reductions in pain intensity and improvement in patients with chronic neuropathic pain.