Medtronic Inceptiv™ Closed-Loop DTM Spinal Cord Stimulation for Painful Diabetic Peripheral Neuropathy

This study is conducted to evaluate a new way of using spinal cord stimulation (SCS) in people with painful diabetic peripheral neuropathy (DPN). The device used is the Medtronic Inceptiv SCS, which is already approved by the U.S. FDA for treatment of chronic pain. In this study, the system will be programmed to deliver Differential Target Multiplexed (DTM) stimulation with closed-loop feedback using signals from the spinal cord (ECAPs). Up to 25 participants will take part in the study, beginning with a short trial phase and continuing to a permanent implant if the trial is successful. Participants will be followed for 12 months after implant. The main goal is to see whether this therapy can safely and effectively reduce pain in people with diabetic neuropathy. Other measures include physical function, symptom profiles, treatment satisfaction, and monitoring for any side effects.

NCT Number	NCT07209514
Lead Sponsor	TriCity Research Center Collaborators: Medtronic
Conditions	Diabetic Peripheral Neuropathic Pain (DPN)
Enrollment	25 participants
Start Date	2025-09-16
Primary Completion	2027-09-15 (estimated)
Study Completion	2027-12-15 (estimated)
Updated on ClinicalTrials.gov	2025-10-15