Early Experience With a Novel Miniaturized Spinal Cord Stimulation System for the Management of Chronic Intractable Pain of the Back and Legs.

Autor: Salmon J; Pain Care Perth and Western Australia, Pain Management, Perth, Western Australia, Australia., Bates D; Metro Pain Group, Pain Management, Melbourne, Victoria, Australia., Du Toit N; Metro Pain Group, Pain Management, Melbourne, Victoria, Australia., Verrills P; Metro Pain Group, Pain Management, Melbourne, Victoria, Australia., Yu J; Sydney Spine and Pain, Pain Management, Sydney, New South Wales, Australia., Taverner MG; Frankston Pain Management, Frankston, Victoria, Australia., Mohabbati V; Sydney Pain Management Centre, Sydney, New South Wales, Australia., Green M; Pain Medicine of South Australia, Pain Management, Adelaide, South Australia, Australia., Heit G; Department of Neurosurgery, Hue University of Medicine and Pharmacy, Hue, Vietnam., Levy R; Institute for Neuromodulation, Neurosurgery, Boca Raton, FL, USA., Staats P; Premier Pain Centers, Shrewsbury, NJ, USA., Ruais J; Nalu Medical, Inc, Carlsbad, CA, USA., Kottalgi S; Nalu Medical, Inc, Carlsbad, CA, USA. Electronic address: skottalgi@nalumed.com., Makous J; Makous Research, LLC, Carlsbad, CA, USA., Mitchell B; Metro Pain Group, Pain Management, Melbourne, Victoria, Australia.
Jazyk: angličtina
Zdroj: Neuromodulation : journal of the International Neuromodulation Society [Neuromodulation] 2023 Jan; Vol. 26 (1), pp. 172-181.
DOI: 10.1016/j.neurom.2022.11.002
Abstrakt: Introduction: A novel, spinal cord stimulation (SCS) system with a battery-free miniaturized implantable pulse generator (IPG) was used in this feasibility study. The system uses an external power source that communicates bidirectionally with the IPG (< 1.5 cm 3 ). Human factors, subject comfort, and effects on low back and leg pain were evaluated in this first-in-human study.
Materials and Methods: A prospective, multicenter, open-label clinical trial was initiated to evaluate the safety and performance of a novel miniaturized stimulator in the treatment of chronic, intractable leg and low-back pain. Eligible subjects were recruited for the study and gave consent. Subjects who passed the screening/trial phase (defined as ≥ 50% decrease in pain) continued to the long-term implant phase and were followed up at predefined time points after device activation. Interim clinical and usability outcomes were captured and reported at 90 days.
Results: Results of 22 subjects who chose a novel pulsed stimulation pattern therapy using the battery-free IPG (< 1.5 cm 3 ) are described here. At 90-days follow-up, the average pain reduction was 79% in the leg (n = 22; p < 0.0001) and 76% in the low back (n = 21; p < 0.0001) compared with baseline. Responder rates (≥ 50% pain relief) at 90 days were 86% in leg pain (19/22) and 81% in low-back pain (17/21). Subjects rated the level of comfort of the external wearable power source to be 0.41 ± 0.73 at 90 days on an 11-point rating scale (0 = very comfortable, 10 = very uncomfortable).
Discussion: These interim results from the ongoing study indicate the favorable efficacy and usability of a novel, externally powered, battery-free SCS IPG (< 1.5 cm 3 ) for leg and low-back pain. Study subjects wore the external power source continuously and found it comfortable, and the system provided significant pain relief. These preliminary findings warrant further investigation.
Clinical Trial Registration: The Clinicaltrials.gov registration number for the study is ACTRN12618001862235.
(Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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