Real World Clinical Utility of Neurophysiological Measurement Utilizing Closed-Loop Spinal Cord Stimulation in a Chronic Pain Population: The ECAP Study Protocol.

Background

Spinal cord stimulation (SCS) is an established chronic pain treatment, but the effectiveness of traditional, open-loop paradigms has been plagued by variable sustainability in a real-world setting. A new approach, utilizing evoked compound action potential (ECAP) controlled closed-loop (CL) SCS, continuously monitors spinal cord activation and automatically adjusts the stimulation amplitude of every pulse, maintaining stimulation at the prescribed ECAP level through this continual feedback mechanism. Recent studies demonstrated the long-term safety and efficacy of ECAP-controlled CL-SCS. Here, we report the design of a prospective, multicenter, single-arm feasibility study to characterize clinical outcomes in a real-world chronic pain population utilizing ECAP-controlled CL-SCS. Objective neurophysiological measurements such as device performance and patient therapy compliance, will be analyzed against baseline biopsychosocial assessments, to explore the clinical utility of these objective physiologic biomarkers in patient phenotyping.

Methods

This study will enroll up to 300 subjects with chronic, intractable trunk and/or limb pain in up to 25 United States investigation sites. Subjects meeting eligibility criteria will undergo a trial procedure and a permanent implant following a successful trial. Neurophysiological measurements (measured in-clinic and continuously during home use) and clinical outcomes including pain, quality-of-life, psychological, emotional, and functional assessments will be collected at baseline, trial end, and up to 24-months post-implantation.

Discussion

Associations between objective neurophysiological data, clinical evaluation and patient-reported outcomes may have important clinical and scientific implications. They may provide novel insights about the chronic pain pathophysiology, its modulation during CL-SCS, and identification of pain phenotypes and/or mechanisms associated with treatment response during SCS trials and long-term therapy. Data from the ECAP study could lead to improvements in diagnosis, assessment, patient identification and management of chronic pain. It could also provide the foundation for development of a new SCS treatment approach customized by the patient's pain phenotype, unique neurophysiology, and disease severity.

Informations de copyright

© 2023 Leitner et al.

Déclaration de conflit d'intérêts

AL, EH and NS are employees of Saluda Medical. PS has received consultancy fees from Medtronic, Saluda Medical, Nalu, and Biotronic and has stock options from Saluda Medical and Nalu. He also reports grants from National Spine. RL is an uncompensated consultant for Biotronik, Nalu, Saluda Medical, and Mainstay Medical and has stock options from Nalu and Saluda Medical obtained before 2019, not exercisable through the duration of his term as International Neuromodulation Society President and Editor-in-Chief of the journal, Neuromodulation: Technology at the Neural Interface. JP serves as a consultant for Abbott, Medtronic, Saluda Medical, Flowonix, SpineThera, Vertos, Vertiflex, SPR Therapeutics, Tersera, Aurora, Spark, Ethos, Biotronik, Mainstay, WISE, Boston Scientific, and Thermaquil; has received grant and research support from: Abbott, Flowonix, Saluda Medical, Aurora, Painteq, Ethos, Muse, Boston Scientific, SPR Therapeutics, Mainstay, Vertos, AIS, and Thermaquil; and is a shareholder of Vertos, SPR Therapeutics, Painteq, Aurora, Spark, Celeri Health, Neural Integrative Solutions, Pacific Research Institute, Thermaquil, and Anesthetic Gas Reclamation. He also reports DRG neuromonitoring patent issued to Neural Integrative Solutions. JK is on the advisory board for Saluda Medical, Boston Scientific, Nevro, Abbott and Medtronic. DD reports consultant fees from Saluda. SL is a consultant for Abbott, Avanos, Averitas Pharm, Biotronik, Boston Scientific, Nalu Medical, Nevro, PainTeq, PRIA Health, Saluda Medical, SPR Therapeutics, Vertos Medical, has equity in Nalu Medical and National Spine and Pain Centers. He has received department research funding from Avanos, Biotronik, Boston Scientific, Ethos Lab, Neuralace, SGX Medical, Nalu Medical, PainTeq, Saluda Medical and SPR Therapeutics. He also reports speaker bureau with Scilex Parma. JW is a consultant for SI Bone, Saluda Medical, Abbott, Medtronic and Biotronik. KA is an investigator and a consultant for Boston Scientific, Nevro, Medtronic, Nalu, Presidio and Biotronik. LP is a consultant for Medtronic, Saluda Medical and Nalu. The authors report no other conflicts of interest in this work.