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

NCT ID: NCT07209514

Last Updated: 2025-10-15

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-16
• Study Completion Date: 2027-12-15

Brief Summary

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.

Conditions

Diabetic Peripheral Neuropathic Pain (DPN)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Implantable SCS with Closed Loop mechanism

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

TriCity Research Center

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Grand Island Pain Relief Center

Grand Island, Nebraska, United States

Countries

United States

Other Identifiers

ERP #14060

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IIS-25-MTR-001

Identifier Type: -

Identifier Source: org_study_id