Diabetic Peripheral Neuropathic Pain (DPN)
Conditions
Keywords
Diabetic Peripheral Neuropathic Pain
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.
Interventions
DEVICEImplantable 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.
Sponsors
Medtronic
TriCity Research Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Intensity on the Visual Analog Scale (VAS, 0-10) from Baseline to 12 Months | Baseline; End of Trial (~7 days after trial lead placement); 1, 3, 6, and 12 months after permanent implant. Primary time point: 12 months. | Pain intensity is assessed with a 0-10 VAS. Scores are collected at each study visit. The primary endpoint is the change score calculated as 12-month VAS minus baseline VAS; negative values indicate improvement (decrease in pain). Analysis will summarize mean change (SD) and 95% CIs. Additional summaries may include the proportion of participants achieving ≥30% and ≥50% reduction as supportive endpoints. |
Countries
United States
Outcome results
None listed