Safety and Efficacy of Axon Therapy (SEAT Study), Utilizing Magnetic Peripheral Nerve Stimulation (mPNS) for Treatment of Neuropathic Pain.

BACKGROUND

Many of the current treatments for chronic neuropathic pain have variable effectiveness and known side effects. Given the prevalence of this type of intractable pain (3-17% of general population), additional therapeutic non-invasive approaches are desired. Magnetic Peripheral Nerve Stimulation (mPNS) delivered at 0.5Hz provides an effective pain relief without side effects. The objective of this randomized, controlled, multi-site clinical trial was to compare long-term safety and efficacy of mPNS in patients with chronic, intractable, post-traumatic or post-surgical neuropathic pain to comprehensive Conventional Medical Management (CMM).

METHODS

A total of 65 patients with post-traumatic, post-surgical neuropathy were treated within a multicenter, randomized, clinical trial comparing the safety and effectiveness of mPNS + CMM to CMM alone. Patients were randomized 1:1 and followed through 90 days. The primary endpoint is a proportion of responders, 50% or greater reduction in pain at Day 90. The secondary endpoints included the European Quality of Life 5 Dimensions 3 Level (EQ-5D-3L) and Patient Global Impression of Change (PGIC).

RESULTS

At 3 months, 71% of subjects were considered responders (>50% pain relief) in the mPNS + CMM group vs 13% of subjects in the CMM group. The mPNS + CMM group had a mean reduction in VAS scores at Day 90 of 3.8 points (>50% reduction), while CMM showed less than a 1-point (0.7 point) mean reduction or ~10% reduction (p < 0.0001). The EQ-5D-3L score increased in the mPNS + CMM study group, whereas the CMM group showed no improvement in EQ-5D-3L at Day 90. PGIC responder rates were 80.6% and 4.3% at Day 90 for mPNS + CMM and CMM groups, respectively.

CONCLUSION

mPNS + CMM was superior to CMM in a randomized prospective study when used for treatment of post-traumatic, post-surgical neuropathy. Due to the lack of other effective non-invasive treatments for neuropathic pain, mPNS should be considered much earlier in the treatment algorithm.