Status:
ENROLLING_BY_INVITATION
Medtronic Inceptiv™ Closed-Loop DTM Spinal Cord Stimulation for Painful Diabetic Peripheral Neuropathy
Lead Sponsor:
TriCity Research Center
Collaborating Sponsors:
Medtronic
Conditions:
Diabetic Peripheral Neuropathic Pain (DPN)
Eligibility:
All Genders
19+ years
Phase:
NA
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 i...
Eligibility Criteria
Inclusion
- 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
- (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.
Key Trial Info
Start Date :
September 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2027
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT07209514
Start Date
September 16 2025
End Date
December 15 2027
Last Update
October 15 2025
Active Locations (1)
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1
Grand Island Pain Relief Center
Grand Island, Nebraska, United States, 68803