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

Part of paid clinical trials in Grand Island, Nebraska.

Sponsor
TriCity Research Center
Study ID
NCT07209514
Status
Enrolling By Invitation

Conditions

  • Diabetic Peripheral Neuropathic Pain (DPN)

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Implantable SCS with Closed Loop mechanism — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Sep 16, 2025
Status verified
Oct 2025
Primary completion
Sep 15, 2027
Completion
Dec 15, 2027

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Inceptiv CL DTM SCS
    Participants undergo a short trial of SCS. Those with a successful trial will receive permanent implantation of the Medtronic Inceptiv SCS with paddle leads. After implant, closed-loop ECAP-guided Differential Target Multiplexed stimulation will be activated and optimized at follow-up visits.

Primary Outcome Measure

Change in Pain Intensity on the Visual Analog Scale (VAS, 0-10) from Baseline to 12 Months [ Time Frame: Baseline; End of Trial (~7 days after trial lead placement); 1, 3, 6, and 12 months after permanent implant. Primary time point: 12 months. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Grand Island Pain Relief CenterGrand IslandNebraska68803-

Find similar trials in Grand Island, NE

By research site
Grand Island Pain Relief Center· Grand Island, NE

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