BENEFIT-01 Study Published in Neuromodulation
BIOTRONIK is pleased to announce the release of the results of the BENEFIT-01 study published in Neuromodulation.1 The prospective, multi-center study was designed to investigate the influence of clinically relevant Spinal Cord Stimulation (SCS) parameters on patient perception. BENEFIT-01 marked the beginning of a series of SCS clinical studies with the aim of developing an SCS technology that provides sustained pain relief with few side effects.
Enrollment
From July to November 2017, 40 patients with low back and/or leg pain who had completed a commercial SCS trial were enrolled at seven clinical sites in the US and underwent approximately 90 minutes of test stimulation prior to trial lead removal. The analysis of this BENEFIT-01 data led to the creation of a map defining the boundary of patient perception of stimulation and revealed that SCS sensations are mainly influenced by pulse width, not frequency. The study also explored alternative electrode configurations, offering valuable insights for improving SCS outcomes.
“This was an incredible opportunity to explore some of the challenges facing conventional SCS therapies,” noted Dr. John Hatheway, the lead author of BENEFIT-01. “These findings advance our understanding of the therapy and have helped pave the way for proprietary stimulation paradigms like RESONANCE™.”
This work represents one aspect of a comprehensive research program supporting the Prospera™ SCS system and BIOTRONIK Neuro’s proprietary multiphase stimulation paradigm, RESONANCE. BIOTRONIK Neuro developed this technology by integrating the results from BENEFIT-01 with SCS modelling, pre-clinical animal studies, and results from BENEFIT-02, a subsequent clinical study that evaluated the short-term safety and effectiveness of multiphase stimulation.
Todd Langevin, BIOTRONIK Neuro President Notes
“BENEFIT-01 was the first in a series of studies that speaks to our commitment to advancing and sharing the science behind SCS. It’s exciting to see these learnings realized as patients experience the positive impact of RESONANCE™ stimulation with our Prospera™ SCS system.”
Results from BENEFIT-02, published in Neuromodulation in October 2023, highlighted the effectiveness of Prospera’s Multiphase Stimulation Paradigm, demonstrating its efficacy in pain relief with lower power requirements.2 Building on these early clinical and pre-clinical results, the BENEFIT-03 study, ongoing in Australia, is evaluating the long-term safety and effectiveness of the Prospera SCS System with RESONANCE and introduced automatic daily device monitoring and remote programming. Interim 12-month results from BENEFIT-03 were presented at the 2024 North American Neuromodulation Society conference last week.3
