Efficacy and Feasibility of BurstDR SCS in Painful Diabetic Neuropathy

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.

NCT Number	NCT07250828
Lead Sponsor	TriCity Research Center Collaborators: Abbott
Conditions	Painful Diabetic Neuropathy (PDN), Diabetic Neuropathy, Neuropathic Pain, Chronic Pain
Enrollment	20 participants
Start Date	2025-12-15
Primary Completion	2027-01 (estimated)
Study Completion	2027-05 (estimated)
Updated on ClinicalTrials.gov	2026-05-08