Presented at the 2012 AAPM Annual Meeting « Back

Efficacy and Convenience of Position-Adaptive Stimulation: Results of the RestoreSensor Study

David M. Schultz, MD, dschultz@painphysicians.com¹, Lynn R. Webster, MD², Peter Kosek, MD³, Mark Sun, PhD⁴, Ye Tan, MS⁴, Mary Robischon, RN⁴ , (1) MAPS Applied Research Center, Edina, Minnesota, (2) Lifetree Clinical Research, Salt Lake City, Utah, (3) Pain Consultants of Oregon, Eugene, Oregon, (4) Medtronic, Inc., Minneapolis, Minnesota

Introduction: Variation in the intensity of neurostimulation with body position is a problem for some patients implanted with spinal cord stimulation systems because positional changes may result in overstimulation or understimulation. The RestoreSensor™ neurostimulator (Medtronic, Inc., Minneapolis, MN) was developed to address this problem. Materials and Methods: The prospective, multicenter, randomized crossover study assessed the efficacy of position-adaptive stimulation (AdaptiveStim™) in terms of pain relief and/or convenience compared with manual programming. Safety objectives compared the number of patients who experienced adverse events associated with uncomfortable stimulation during both study arms and summarized all adverse events. Seventy-nine patients were enrolled in the IRB-approved study. Patients were implanted with the RestoreSensor device and randomized to 6 weeks of position-adaptive stimulation adjustment or manual programming. Crossover to the opposite assignment occurred at week 6. Results: In an intent-to-treat analysis, 86.5% of patients achieved the primary objective of improved pain relief with no loss of convenience or improved convenience with no loss of pain relief when using automatic position-adaptive stimulation. The results were significantly greater than the predefined minimum success rate of 25%, p<0.001. There was no significant difference in adverse events associated with uncomfortable sensations from stimulation between study arms, and the overall adverse event profiles were also similar. The incidence of device-related serious adverse events was 3.9%. Conclusions: This study demonstrated that position-adaptive stimulation is safe and improves pain relief and convenience in patients indicated for spinal cord stimulation for the treatment of chronic trunk and/or limb pain compared with manual programming. The RestoreSensor study was funded by Medtronic, Inc.

Funding: None