10 Khz Spinal Cord Stimulation For Treatment Of Painful Diabetic Neuropathy: A Multicenter Randomized Controlled Trial

Objective: Prospective, multicenter, randomized controlled trial (SENZA-PDN) to document the impact of 10 kHz spinal cord stimulation (SCS) on painful diabetic neuropathy (PDN). Background: The Centers for Disease Control and Prevention estimates there are 29 and 86 million people in the US living with diabetes and prediabetes, respectively.1 Approximately 20% of patients with diabetes will develop PDN,2 a debilitating, progressive chronic pain condition that significantly impacts patients’ health-related quality of life (HRQoL). Neither pharmacological treatments nor low-frequency SCS has provided significant, long-term relief for PDN patients;3–6 however, preliminary observational data suggest 10 kHz SCS may relieve pain and reverse sensory deficits from peripheral polyneuropathy.7 Design/Methods: In total, 216 subjects with PDN were assigned 1:1 to 10 kHz SCS combined with conventional medical management (CMM) or CMM alone. Key inclusion criteria included: clinical diagnosis of PDN with symptoms ≥12 months, average lower limb pain intensity ≥5 cm (on a 0–10 cm visual analog scale [VAS]), and appropriate candidate for SCS. Key exclusion criteria included: hemoglobin A1c \u003e10%, daily opioid dosage \u003e120 mg morphine equivalents, and average upper limb pain intensity ≥3 cm. The primary endpoint compares responder rates (≥50% pain relief) and safety rates between the treatment groups at 3 months. Secondary endpoints include neurological function, HRQoL, sleep quality, patient satisfaction, and cost-effectiveness data. Participant follow-up will last 24 months. Results: Enrollment in SENZA-PDN commenced in 2017 and completed in 2019. Screening 430 candidates resulted in 113 subjects randomized to 10 kHz SCS+CMM and 103 to CMM alone. Outcomes reported will include demographics, and 3-month follow-up of average VAS scores, responder rates, adverse events, neurological assessment, and other secondary and observational outcomes. Conclusions: The SENZA-PDN study is the largest RCT to date of SCS management of PDN patients and will help inform the place of 10 kHz SCS in the PDN treatment continuum. Disclosure: Dr. Petersen has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Medtronic, Neuros Medical, Nevro, and Abbott. Dr. Petersen has received compensation for serving on the Board of Directors of SynerFuse. Dr. Petersen has received research support from Medtronic, Neuros Medical, ReNeuron, and Nevro. Dr. Stauss has nothing to disclose. Dr. Scowcroft has received research support from Nevro, Saluda, Boston Scientific, Vertiflex. Dr. White has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Lilly. Dr. Sills has received research support from Nevro. Dr. Amirdelfan has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Nevro, Nalu, Saluda, Biotronik, Medtronic. Dr. Amirdelfan has received compensation for serving on the Board of Directors of Nevro, Nalu. Dr. Amirdelfan has received research support from Nevro, Biotronik, Vivex, Saluda, SPR Therapeutics. Dr. Guirguis has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Boston Scientific and Avanos. Dr. Guirguis has received research support from Abbott, Boston Scientific, Neurous, and Nevro. Dr. Xu has received research support from Nevro. Dr. Yu has received research support from Nevro. Dr. Nairizi has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Nevro, Flowonix. Dr. Galan has received research support from Medtronic, Nevro, SPR Therapeutics, St. Jude, and Biotronik. Dr. Bundschu holds stock and/or stock options in Nevro which sponsored research in which Dr. Bundschu was involved as an investigator. Dr. Bundschu has received research support from Nevro and Stimgenics. Dr. Mehta has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Nevro, Salix Pharma, Biodelivery Sciences, Sollis Therapeutics. Dr. Mehta has received research support from Nevro, Boston Scientific, Medtronic. Dr. Sayed has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Nevro. Dr. Sayed has received compensation for serving on the Board of Directors of Nevro. Dr. Sayed has received research support from Nevro. Dr. Lad has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Abbott, Boston Scientific, Medtronic, Minnetronix and Nevro, Inc. Dr. Lad has received research support from Abbott, Boston Scientific, Medtronic, Minnetronix and Nevro, Inc.. Dr. DiBenedetto has nothing to disclose. Dr. Sethi has nothing to disclose. Dr. Wu has nothing to disclose. Dr. Argoff has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Allergan, BDSI, Collegium, Daiichi Sakyo, Lilly, Pfizer, Teva, Regeneron, Amgen, Novartis, Scilex,. Dr. Argoff has received personal compensation in an editorial capacity for Neuropathic Pain Section Co-Editor, Pain Medicine. Dr. Argoff holds stock and/or stock options in Pfizer, Inc which sponsored research in which Dr. Argoff was involved as an investigator. Dr. Argoff has received research support from Needs to be completed. Dr. Nasr has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Shire, Nevro, Eisai, Exelixis. Dr. Taylor has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Nevro, Medtronic, Saluda. Dr. Brooks has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Nevro. Dr. Brooks holds stock and/or stock options in Nevro. Dr. Subbaroyan has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Nevro Corp. Dr. Subbaroyan has received compensation for serving on the Board of Directors of Nevro Corp. Dr. Subbaroyan holds stock and/or stock options in Nevro Corp. Dr. Gliner has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Nevro Corp. Dr. Gliner holds stock and/or stock options in Nevro Corp. Dr. Caraway has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Nevro Corp. Dr. Caraway has received compensation for serving on the Board of Directors of Nevro Corp. Dr. Caraway holds stock and/or stock options in Nevro Corp. Dr. Mekhail has nothing to disclose.