Medtronic Inceptiv™ Closed-Loop DTM Spinal Cord Stimulation for Painful Diabetic Peripheral Neuropathy (MED DPN)

TriCity Research Center

Status: Invitation-only

Conditions: Diabetic Peripheral Neuropathic Pain (DPN)

Treatments: Device: Implantable SCS with Closed Loop mechanism

Study type: Interventional

Funder types: Industry

Identifiers

NCT07209514

ERP #14060 (Other Grant/Funding Number)

IIS-25-MTR-001

Details and patient eligibility

About

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.

Enrollment: 25 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Inceptiv CL DTM SCS

Experimental group

Description:

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.

Treatment:

Device: Implantable SCS with Closed Loop mechanism