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The American Society of Pain and Neuroscience (ASPN) Guidelines and Consensus on the Definition, Current Evidence, Clinical Use and Future Applications for Physiologic Closed-Loop Controlled Neuromodulation in Chronic Pain: A NEURON Group Project.
Authors
Pope JE, Deer TR, Sayed D, Antony AB, Bhandal HS, Calodney AK, Chakravarthy K, Costandi S, Diep J, Durbhakula S, Fishman MA, Gilligan C, Goree JH, Guirguis M, Hagedorn JM, Hunter CW, Kallewaard JW, Kapural L, Lam CM, Li S, Mayrsohn B, Nijhuis H, Nikolic S, Petersen EA, Poree LR, Puri SK, Reece DE, Rosen SM, Russo MA, Shah JM, Staats PS, Verrills P, Vu CM, Levy RM, Mekhail NAbstract
Neuromodulation has been a staple of treatment for moderate-to-severe chronic refractory pain since the introduction of the first spinal cord stimulator by Norman Shealy in 1967. Appreciating the dynamic nature of electrical modulation of the nervous system from the epidural space, the goal has been consistent, reliable, and therapeutic neural activation of the spinal cord. This has proven to be extremely difficult. Recently, the Food and Drug Administration (FDA) released a guidance on physiologic closed loop controlled (PCLC) devices, highlighting the potential for these therapies to deliver accurate, consistent, real-time therapy, enhancing medical care and reducing variability. Because of the growing neuromodulation market focus on PCLC strategies, the American Society of Pain and Neuroscience (ASPN) sought to develop guidance on safety and efficacy, along with a taxonomy surrounding PCLC systems (PCLCSs) and to develop an evidence-based best practice review.