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

NAEnrolling by invitationINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

September 16, 2025

Primary Completion Date

September 15, 2027

Study Completion Date

December 15, 2027

Conditions
Diabetic Peripheral Neuropathic Pain (DPN)
Interventions
DEVICE

Implantable SCS with Closed Loop mechanism

Participants will be treated with an implantable spinal cord stimulation system programmed to deliver differentially multiplexed targeting pulse program with closed-loop adjustment using evoked compound action potential feedback. All subjects will first undergo a short percutaneous trial phase of spinal cord stimulation. Those who meet trial success criteria will then receive permanent implantation with a paddle lead and the implantable pulse generator. After implantation, closed-loop DTM therapy will be enabled and optimized at each follow-up visit. The goal of the intervention is to evaluate feasibility, safety, and effectiveness of closed-loop DTM spinal cord stimulation in patients with painful diabetic peripheral neuropathy.

Trial Locations (1)

68803

Grand Island Pain Relief Center, Grand Island

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Medtronic

INDUSTRY

lead

TriCity Research Center

INDUSTRY