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Overview

There has been a significant improvement in the quality of clinical research performed in the field of neuromodulation over the last 40 years. Simple observational and retrospective studies have largely been replaced with prospective, randomized trials as the current level of medical evidence demands. That being said, recently published studies continue to have multiple significant biases, suboptimal outcomes assessments and lack sufficient follow-up. This has been the focus of much recently published research and expert research recommendations. Those in the field of neuromodulation involved in the design or execution of future studies need to be aware of these issues and recommendations. Furthermore, neuromodulation practitioners need to be aware of these issues and recommendations to be able to properly assess the design and quality of execution of these important future studies

Program

Moderators: Robert Levy, MD, PhD and Julie Pilitsis, MD, PhD.

Presenters:

Shashank Vodapally, DO.

Presented Authors:

Robert Levy, MD, PhD and Lawrence Poree, MD, PhD.

Articles to be reviewed

1) Leitner A, Hanson E, Soliday N, Staats P, Levy R, Pope J, Kallewaard JW, Doleys D, Li S, Weisbein J, Amirdelfan K, Poree L. Real World Clinical Utility of Neurophysiological Measurement Utilizing Closed-Loop Spinal Cord Stimulation in a Chronic Pain Population: The ECAP Study Protocol. J Pain Res. 2023 Jul 21;16:2497-2507. doi: 10.2147/JPR.S411927. PMID: 37497371; PMCID: PMC10368120. 2) Kapural L, Mekhail NA, Costandi S, Gilmore C, Pope JE, Li S, Hunter CW, Poree L, Staats PS, Taylor RS, Eldabe S, Kallewaard JW, Thomson S, Petersen EA, Sayed D, Deer TR, Antony A, Budwany R, Leitner A, Soliday N, Duarte RV, Levy RM. Durable multimodal and holistic response for physiologic closed-loop spinal cord stimulation supported by objective evidence from the EVOKE double-blind randomized controlled trial. Regional Anesthesia & Pain Medicine Published Online First: 25 July 2023. doi: 10.1136/rapm-2023-104639 3) Falowski SM, Burgher AH, Pope JE, Gilmore CA, Qureshi FA, Staats PS, Scowcroft J, McJunkin T, Carlson J, Kim CK, Yang MI, Stauss T, Pilitsis J, Poree L; Evoke Study Group; Brounstein D, Gilbert S, Gmel GE, Gorman R, Gould I, Hanson E, Karantonis DM, Khurram A, Leitner A, Mugan D, Obradovic M, Ouyang Z, Parker J, Single P, Soliday N. Durability of Clinical and Quality-of-Life Outcomes of Closed-Loop Spinal Cord Stimulation for Chronic Back and Leg Pain: A Secondary Analysis of the Evoke Randomized Clinical Trial. JAMA Neurol. 2022 Mar 1;79(3):251-260. doi: 10.1001/jamaneurol.2021.4998. Erratum in: JAMA Neurol. 2022 Feb 14;:null. PMID: 34998276; PMCID: PMC8742908.

Register