Disclosures: Joel P. Castellanos, MD: No financial relationships or conflicts of interest

Objective: To investigate the potential role and effect of high frequency spinal cord stimulation in patients with painful diabetic neuropathy on peripheral nerves.

Design: Prospective, non-randomized, observational study Setting : Academic Medical Center Participants : Patients with painful diabetic neuropathy

Interventions: This study involves implantation of high frequency SCS utilizing the HF 10 therapy system (Senza® System; Nevro Corp., USA)

Main Outcome Measures: In each patient, pre-SCS implantation skin biopsy and corneal confocal microscopy has been performed and repeated at 3,6, and 12 month time intervals post-implatation. Visual analog scale, neuropathic pain scale, Short-Form 36, Neuropen are also recorded at each of these time points.

Results: Since beginning enrollment, we have had one patient that has the 6 month post-operative time-point. As seen in Figures 1 and 2, since HF10 therapy, this patient has demonstrated increased corneal innervation and corneal nerve density Conclusions: Spinal cord stimulation, including HF10 therapy, for peripheral neuropathy is on-label use, but the efficacy of high frequency stimulation at 10 kHz in the treatment of painful peripheral neuropathy (and on intra-epidermal nerve fibers and corneal confocal microscopy) is not known, and is being investigated in this study. This study exclusively tests HF10 therapy, and conventional stimulation will not be used. Preliminary results demonstrate improved corneal nerve density in one patient after HF10 therapy at 1 month, 3 months, and 6 months post operatively.

Level of Evidence: Level IV

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PM&R Meeting Abstracts - https://pmrjabstracts.org/abstract/evaluation-of-high-frequency-spinal-cord-stimulation-scs-on-intra-epidermal-nerve-fibers-in-diabetic-peripheral-neuropathy-preliminary-findings/