Presented at the 2012 AAPM Annual Meeting « Back

Results of the RestoreSensor Study: Assessment of Device Programming for Position-Adaptive Spinal Cord Stimulation

Lynn R. Webster, MD, lrwebstermd@gmail.com¹, David M. Schultz, MD², John R. Roberts, MD³, Sanghamitra Basu, MD⁴, Dennis Skelton, BS⁵, Eric Panken, MS⁵, Mark Sun, PhD⁵, Ye Tan, MS⁵, Mary Robischon, RN⁵, (1) Lifetree Clinical Research, Salt Lake City, Utah, (2) MAPS Applied Research Center, Edina, Minnesota, (3) Huntsville Hospital, Huntsville, Alabama, (4) Sans Pain Clinic, North Las Vegas, Nevada, (5) Medtronic, Inc., Minneapolis, Minnesota

Introduction: Frequent manual therapy adjustments can be burdensome and may decrease satisfaction with spinal cord stimulation. A position-adaptive stimulation feature may reduce the need for adjustments. Materials and Methods: Patients received 6 weeks of manual programming and 6 weeks of position-adaptive stimulation (AdaptiveStim™) with the RestoreSensor™ neurostimulator (Medtronic, Inc., Minneapolis, MN) in a prospective, crossover, IRB-approved study. Clinicians oriented the device to the patient’s body positions during device setup and could also adjust the default parameters. They also determined the amplitude for specific positions. Patients could further adjust stimulation amplitude. The patient programmer automatically logged all adjustments. Clinicians and patients were surveyed on ease-of-use after orientation using a 5-point Likert scale. Results: Fifty (65.8%) of 76 implanted patients considered moving between positions during orientation to be easy or very easy. Clinicians reported that the process was easy or very easy for most patients (N = 66, 86.8%). Throughout the study, 54 (71%) of patients used the default transition times; 59 (77.6%) the default mobility rate; 67 (88.2%) the default position range for the upright position; and 64 (84.2%) the default position range for lying down. Data on manual therapy adjustments were available for 69 patients. Compared to manual programming, position-adaptive stimulation demonstrated a statistically significant 41% reduction in daily average programming button presses, p<0.001 and in daily average adjustments for amplitude, p = 0.002. Conclusions: Clinicians reported that programming required to initialize position-adaptive stimulation was easy or very easy in most cases. Position-adaptive stimulation also significantly decreased the programming burden for patients.

Funding: The RestoreSensor study was funded by Medtronic Neuromodulation.