25
Participants
Start Date
September 16, 2025
Primary Completion Date
September 15, 2027
Study Completion Date
December 15, 2027
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.
Grand Island Pain Relief Center, Grand Island
Collaborators (1)
Medtronic
INDUSTRY
TriCity Research Center
INDUSTRY