(58) Reduction of Dysesthesias in Painful Diabetic Peripheral Neuropathy with 10 kHz Spinal Cord Stimulation

Introduction: Up to 25% of diabetes patients develop painful diabetic neuropathy (PDN) or neurological symptoms, including dysesthesias. In a large randomized controlled trial, we assessed neurological function in patients with painful diabetic neuropathy in response to 10 kHz spinal cord stimulation (SCS) [1,2].

Methods: During baseline and 3, 6, and 12-month post-implant visits for the study, subjects were asked to report their current perception of five dysesthesias: Pain, Burning, Cold, Numbness, and Tingling. Subjects were presented with a touchscreen tablet and were shown a body diagram on which they could draw to report these dysesthesias. Custom software was used to isolate the subject-drawn images. The isolated images were then digitally layered and averaged, separated by dysesthesia type and follow up visit, so that each pixel of the body diagram had an associated value from 0-100%, depending on the proportion of subjects who shaded that particular pixel of the body diagram for that dysesthesia type at that visit. For dataset robustness, only subjects who were able to provide data at every timepoint were included (i.e., they did not miss any follow-up visits and were given the opportunity to share their current dysesthesias at each visit).

Results: At baseline, the subject in this example colored from below the knee down to the toes. After 3 months, the subject colored from the ankle and most of the surface distal to it on the ventral surface and from the heel and distal to it on the plantar surface. At the 6 and 12-month visits, the subject only shaded a very small region of the toes. At baseline, over 90% (dark red on the color legend) of subjects reported feeling at least a small area of pain and numbness on the feet, with decreasing proportions as the patients colored more proximally. At all later visits, the subjects shaded substantially less area, with maximum shaded proportions around 55% (yellow) for pain and 70% (orange) for numbness. Moreover, for both pain and numbness, there was a substantial reduction in shading of the legs overall.

Conclusion: Subjects reported profound reductions in dysesthesias after 3 months of 10 kHz SCS therapy which was durable to at least 12 months. These results demonstrate that improvements in subject outcomes is not limited only to pain, but a variety of sensory percepts. The observed reductions in dysesthesias suggest that 10kHz SCS can improve sensory processing and may have implications for the progression of the disease state.