TriCity Research Center
This prospective, single-arm clinical study evaluates the therapeutic efficacy and feasibility of BurstDR spinal cord stimulation (SCS) using Abbott's Proclaim XR and Eterna systems in patients with painful diabetic neuropathy (PDN). Adults with confirmed PDN will undergo a one-week temporary SCS trial, and those achieving meaningful improvement (≥50% reduction in average pain on the Visual Analog Scale) will proceed to permanent implantation. Outcomes will be assessed at baseline, end of trial, and at 1-, 3-, and 6-month follow-up visits using validated instruments including VAS, DN4, DQoL, PSQ-3, the Patient Global Impression of Change, and the Clinician Global Impression of Change. All procedures follow standard clinical practice for SCS therapy. The study aims to characterize real-world effectiveness, patient-reported outcomes, feasibility of implementation, and device-related safety in a rural PDN population.
This investigator-initiated, post-market clinical study is designed to evaluate the efficacy, feasibility, and safety of BurstDR spinal cord stimulation (SCS) for the management of painful diabetic neuropathy (PDN) using Abbott's Proclaim XR and Eterna implantable pulse generator systems. The SCS systems used in this study are FDA-approved for PDN, and all clinical procedures-including the percutaneous trial phase and permanent implantation-are performed according to standard-of-care practice by experienced clinicians. Eligible participants are adults aged 19 years or older with confirmed dia…
Inclusion Criteria: * Age 19 years or older. * Diagnosis of diabetic peripheral neuropathy (DPN) confirmed by nerve conduction study (EMG/NCS) or skin biopsy. * Persistent neuropathic pain in the lower extremities for ≥6 months. * Average baseline pain score of ≥6 on the Visual Analog Scale (VAS). * DN4 score ≥4, indicating neuropathic pain characteristics. * Inadequate pain relief with conventional medical therapy, including at least two classes of analgesic or neuropathic pain medications (e.g., gabapentinoids, SNRIs, TCAs, opioids). * Candidate for spinal cord stimulation based on clinical…
Participants receive BurstDR spinal cord stimulation delivered through Abbott Proclaim XR or Eterna spinal cord stimulator systems in a standard of care routine. The intervention includes a one-week temporary SCS trial using percutaneous leads, followed by permanent implantation of the Proclaim XR or Eterna implantable pulse generator for participants who experience meaningful pain relief during the trial. Device programming and follow-up assessments follow standard clinical practice.
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