On October 7, 2025, significant progress was announced regarding pain management solutions for diabetic peripheral neuropathy (DPN). Medtronic, in collaboration with TriCity Research Center, is enrolling patients by invitation for a clinical trial evaluating the Inceptiv™ Closed-Loop DTM Spinal Cord Stimulation (SCS) device. This trial targets patients suffering from diabetic peripheral neuropathic pain, presenting an innovative approach to address one of diabetes’s most challenging complications.
What changed?
This clinical trial reflects a shift in innovation by harnessing closed-loop spinal cord stimulation to improve patient outcomes for DPN-associated pain. Medtronic aims to combine device efficacy with tailored patient care to meet a pressing healthcare need. Regulatory teams and clinical professionals should examine this model’s potential to provide long-term relief and scalable solutions.
What is the device and intervention?
The Inceptiv™ Closed-Loop Spinal Cord Stimulation leverages advanced technology to interpret and adapt nerve signals in real time. This mechanism aims to achieve consistent therapeutic stimulation tailored to individual neurophysiological responses. Designed for DPN, the device seeks to address chronic pain that affects quality of life and often resists conventional medical treatments.
Supported by device manufacturer Medtronic and co-sponsor TriCity Research Center, the trial introduces a novel intervention with a closed-loop mechanism that automatically adjusts stimulation levels, reducing manual programming burdens.
Device features
- Implantable spinal cord stimulator
- Continuous feedback loop to modulate therapy
- Designed to maintain efficacy across variable patient conditions
Who is eligible?
The trial focuses exclusively on individuals with diabetic peripheral neuropathic pain. Enrollment is by invitation only, emphasizing proper candidate identification to ensure targeted outcomes. Healthcare providers managing diabetes patients with severe neuropathic pain should consider discussing the trial’s implications.
Patients may be selected based on factors such as severity of neuropathic symptoms, previous treatments, and overall health condition. The trial investigators aim to provide personalized care while protecting patient safety.
Frequently Asked Questions
- What is closed-loop stimulation?
Closed-loop stimulation refers to technology that automatically adjusts electrical signals based on real-time feedback from the body. - Who sponsors this trial?
The trial is sponsored by TriCity Research Center in collaboration with Medtronic, a global leader in medical device innovation. - Is enrollment open?
Enrollment is by invitation, limiting participation to pre-identified eligible patients.
Conclusion
Medtronic’s pursuit of closed-loop spinal cord stimulation marks a step forward in addressing diabetic peripheral neuropathic pain through innovative medical technology. This trial not only reinforces advancements in spinal cord stimulation but also stresses patient-centered outcomes. Regulatory experts, clinicians, and device manufacturers should follow these developments closely and consider their implications on broader medical practices.
Disclaimer
The information provided here is intended for educational purposes and professional audiences. It does not constitute legal or clinical advice. Readers should consult regulatory guidelines and legal counsel for specific compliance inquiries concerning medical devices.
Announcement Link
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07209514?term=medical+device