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

Feasibility and Therapeutic Efficacy Study of Medtronic's DTM-Closed-Loop Integrated SCS Technology for Managing Diabetic Peripheral Neuropathic Pain (DPN)

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.

• Inclusion Criteria:

  1. Adults ≥19 years.
  2. Confirmed DPN with EMG evidence of peripheral nerve dysfunction.
  3. Persistent lower-limb neuropathic pain VAS ≥6 for ≥6 months despite prior pharmacologic therapy.
  4. HbA1c ≤8.5% within 3 months prior to enrollment.
  5. No prior SCS/neuromodulation therapy; medically eligible for paddle lead implantation with Inceptiv IPG.
  6. Insurance approval or financial ability to cover SCS therapy; able to consent and comply.

• Exclusion Criteria:

  (a) Non-diabetic neuropathies other conditions contributing to lower-limb pain. (b) Contraindications to surgical implantation.

  (c) History of neurostimulation therapy; active substance abuse or uncontrolled psychiatric illness.

  (d) Pregnancy or plans for pregnancy; known allergy to device materials; inability to provide informed consent.