Long-term Study of an SCS System with Multiphase Stimulation and Remote Device Management: 12-month Results

Introduction: The ongoing, long-term BENEFIT-03 study (NCT04683718) is evaluating an implantable spinal cord stimulation (SCS) system with proprietary multiphase stimulation, which demonstrated significant pain relief in a short-term trial.1 The SCS system also enables proactive care by offering automatic, objective, daily remote monitoring and remote programming.2 In 2023, a protocol amendment increased the study size from 30 to 60 fully enrolled participants. We report preliminary 12-month effectiveness and safety outcomes for this expanded cohort; final data analysis is planned for late-breaking presentation.

Methods: BENEFIT-03 is a prospective, multicenter, single-arm study ongoing in Australia with Human Research Ethics Committee approval enrolling consenting participants with chronic low back and/or leg pain. Post-implant follow-up consists of in-office visits (up to 24 months) and remote visits initiated by participants, investigators, proactive triggers (via remote device monitoring), or patient-reported outcomes (PROs). Primary endpoints are responder rate (≥50% overall pain relief, VAS) and freedom from device-related complications at 6 months. Additional outcomes include daily at-home PROs (pain intensity, sleep quality), Oswestry Disability Index (ODI) and opioid medication usage.

Results: At time of analysis, 26 implanted participants had completed 12-month follow-up. Responder rates (≥50% relief, VAS) at 12 months were 80.0% (back pain), 91.7% (leg pain) and 84.6% (overall pain). Mean overall pain intensity (VAS) at 12 months was 21.5mm versus 80.3mm at baseline and mean overall percentage pain relief (PPR) was 73.6%. Trends in daily at-home PROs were consistent with in-clinic results: mean at-home daily pain intensity (NRS) was 2.3 at 12 months versus 7.3 at baseline. ODI scores substantially improved, with 76.9% of participants reporting minimal/moderate disability at 12 months (baseline=3.8%). Additionally, of baseline opioid users, 63.2% fully eliminated use or reduced opioid dose ≥50% by 12 months. Regarding safety, three device- or procedure-related serious adverse events (AEs) were reported. Completion of 12-month follow-up for the expanded cohort is anticipated in time for late-breaking presentation of updated results.

Conclusion: At 12 months post-implant, participants reported substantial pain relief in-clinic and at-home and less severe disability. Most participants on opioids at baseline eliminated or substantially reduced dose, and serious device- or procedure-related AEs were rare. These interim 12-month findings from this expanded cohort add to growing evidence supporting the long-term safety and effectiveness of this SCS system with multiphase stimulation, remote device management, and proactive care. Planned analysis of complete 12-month follow-up data will provide important confirmation of long-term outcomes.