Design of a Multicenter, Randomized Controlled Trial for the Treatment of Peripheral Neuropathic Pain (COMFORT Study) with a Micro-Implantable Pulse Generator.

Background

Peripheral Nerve Stimulation (PNS) is an established therapy for chronic neuropathic pain of peripheral origin, typically following nerve injury. However, there is a paucity of Randomized Controlled Trials (RCTs) demonstrating the therapeutic benefits of PNS. The goals of the current study (COMFORT Study) are to document the safety and efficacy of the Nalu Neurostimulation in a PNS RCT, compared to conventional medical management (CMM).

Methods/Design

This is a prospective, multicenter, RCT evaluating the treatment of neuropathic pain with PNS therapy. One of the following four regions will be targeted for treatment: low back, shoulder, knee or foot/ankle. Consented subjects will undergo a baseline evaluation, after which they are randomized 2:1 (PNS+CMM arm to CMM arm). Subjects randomized to PNS+CMM arm will undergo a trial implant period using best clinical practices. Subjects who pass the trial phase, by showing a ≥ 50% reduction in pain relative to baseline, will receive the permanent implant. All subjects receiving a permanent implant will be followed for a total of 36 months. At the 3-month primary end point, subjects in CMM arm will be given the option to crossover into PNS+CMM arm, beginning with a trial implant. The study duration is expected to be 5.5 years from first enrollment to last follow-up of last subject and subsequent study closure. Adverse events will be captured throughout the study.

Discussion

The COMFORT study, described here, has the potential to demonstrate the efficacy and safety of the Nalu Neurostimulation System in the treatment of peripheral neuropathy. Results of this study will be the first Level-I evidence, out to 36 months, validating the use of this PNS system in the treatment of chronic pain. This study is designed to enroll the largest cohort, to date, of subjects comparing PNS+CMM vs CMM alone.

Peripheral nerve stimulation (PNS) has been used for decades to treat neuropathic pain of peripheral origin. This therapy typically involves the placement small (~1 mm diameter) cylindrical electrodes (leads) near the nerve(s) in question, which is then followed by the delivery mild electrical pulses to the target, thereby blocking the pain signal from reaching the central nervous system. Despite the clinical success of this approach, there are few randomized controlled trials (RCTs) demonstrating PNS efficacy in the treatment of peripheral neuralgia/neuropathy. This may be, in large part, due to a paucity of PNS devices that are small enough to deliver this therapy at multiple locations in the extremities and the torso. For example, most implantable pulse generators (IPGs) range in size from 14 to 40 cm

Informations de copyright

© 2024 Hatheway et al.

Déclaration de conflit d'intérêts

Dr. Heit was a consultant at Nalu Medical, Agitated Solutions, and a co-founder of Nesos Inc. Dr Staats is a consultant for Nalu Medical, Saluda, SPR Therapeutics, Medtronic. He is Chief Medical Officer of National Spine and Pain Centers, electroCore, and World Institute of Pain. Shilpa Kottalgi is an employee at Nalu Medical. James Makous is a consultant at Nalu Medical, owns stock in Nalu Medical and has received personal fees from BackStop Neural, outside the submitted work. Dr. Hatheway is a speaker and consultant for Nalu Medical. Mehul J. Desai consults for Avanos, Nalu, SPR Therapeutics; receives research support from Abbott, Avanos, Averitas, Mainstay, Nalu, Nature Cell, Saol, SPR Therapeutics, Vivex; and owns stock options in SPR Therapeutics, SynerFuse, and Virdio. Dr. Hatheway slso reports Research, Consulting, Speaking Not related to this study from Medtronic. Dr Mitchell Engle reports personal fees from Nalu Medical, personal fees from Nalu Medical, during the conduct of the study; personal fees from SPR Therapeutics, personal fees from Boston Scientific, personal fees from Nevro, personal fees from Saol Therapeutics, outside the submitted work. Dr Genaro Gutierrez reports grants, non-financial support from Nalu, during the conduct of the study; personal fees from Nalu, outside the submitted work. Dr Vishal Khemlani reports personal fees from Nalu, during the conduct of the study; personal fees from Nalu, outside the submitted work. Dr Leonardo Kapural reports grants from Nalu, during the conduct of the study; grants, Scientific board from Nalu, grants, personal fees from Neuros, grants, personal fees from Nevro, grants, personal fees from Saluda, grants, personal fees from Biotronik, outside the submitted work. Dr Drew Trainor reports personal fees from Boston Scientific, personal fees from Vertos, personal fees from Promethean Medical, outside the submitted work. Dr Jennifer Hah reports Research funding and consultant fees from Nalu Medical, outside the submitted work. Dr James Makous reports personal fees from Nalu Medical, during the conduct of the study; personal fees from BackStop Neural, outside the submitted work. Dr Mehul Desai reports grants, personal fees from Nalu Medical, during the conduct of the study; personal fees from Medtronic, personal fees from SPR Therapeutics, Royalties from VYRSA/Nevro, Stock Options from Virdio Health, outside the submitted work. The authors report no other conflicts of interest in this work.