NCT07209514
Medtronic Inceptiv™ Closed-Loop DTM Spinal Cord Stimulation for Painful Diabetic Peripheral Neuropathy
Enrolling by Invitation
NAAges 19+InterventionalTreatmentTriCity Research Center
~25 participants
Updated 2025-10-15 on ClinicalTrials.gov
What's tested:Implantable SCS with Closed Loop mechanism
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Pain Intensity on the Visual Analog Scale (VAS, 0-10) from Baseline to 12 Months
Measured over Baseline; End of Trial (~7 days after trial lead placement); 1, 3, 6, and 12 months after permanent implant. Primary time point: 12 months.
Conditions
Where it's being run
1 sites across 1 statesNebraska1
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- Change in Pain Intensity on the Visual Analog Scale (VAS, 0-10) from Baseline to 12 MonthsBaseline; 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.