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

Key facts

Who runs it
TriCity Research Center
Where
Grand Island, United StatesSee the site
Trial code
Status
Enrolling by invitation
People taking part
25 people, planned
Started
16 Sept 2025
Expected to end
15 Dec 2027
Type of study
Interventional
Treatments tested
  • Implantable SCS with Closed Loop mechanism
Record updated
15 October 2025

Who can take part

Age
19 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 2 criteriaShow less

Other criteria

  • Inclusion Criteria:; Adults ≥19 years; Confirmed DPN with EMG evidence of peripheral nerve dysfunction; Persistent lower-limb neuropathic pain VAS ≥6 for ≥6 months despite prior pharmacologic therapy; HbA1c ≤8.5% within 3 months prior to enrollment; No prior SCS/neuromodulation therapy; medically eligible for paddle lead implantation with Inceptiv IPG; 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

Where in United States

  • Grand Island Pain Relief CenterGrand Island, United StatesEnrolling by invitation

About the trial

What the trial wants to find out

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.

The group in the trial

  • Inceptiv CL DTM SCSTreatment being tested

    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: Implantable SCS with Closed Loop mechanism

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Feasibility and Therapeutic Efficacy Study of Medtronic's DTM-Closed-Loop Integrated SCS Technology for Managing Diabetic Peripheral Neuropathic Pain (DPN)
Record updated
15 October 2025