Nevro Spinal Cord Stimulation for Painful Diabetic Neuropathy
This study is looking at how well Nevro's Spinal Cord Stimulator (SCS) works in real-world settings for people with chronic, severe leg pain caused by painful diabetic neuropathy (PDN). The SCS system is a device that delivers electrical stimulation to the spinal cord to help manage pain. You might be able to join if you have been diagnosed with diabetes and PDN in your lower limbs that hasn't improved with other treatments. The study will measure success by looking at how many people respond to the treatment after 2 weeks, and how much pain relief they report in their overall pain and leg pain after 12 months. This is a global study and its current recruitment status is unclear.
- Study design
- This is a global study planning to enroll 497 participants. It is a prospective, observational study, meaning researchers will follow participants over time.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants' pain relief will be assessed for up to 12 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
PDN Post Market, Multicenter, Prospective, Global Clinical Study
At a glance
Conditions
Where it's being run
8 sites across 7 statesStudy leadership
- David Caraway, MD · STUDY_DIRECTOR · Chief Medical Officer, Nevro Corp
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- Trial success rate/Responder rate2 weeks
Percentage of patients with a successful trial phase (responder rate) i.e. at least 50% reduction in patient-reported overall pain relief.
- Patient-reported overall pain relief12 months
The average percentage of patient-reported pain relief at 3,6 and 12 months.
- Leg pain12 months
Leg pain will be assessed using a 10 cm Visual Analog Scale (VAS) with 0 indicating no pain and 10 indicating the worst pain. Following outcome measures will be derived from the VAS score on leg pain. * Responder rate for leg pain i.e. percentage of patients who experience at least 50% reduction in leg pain compared to Baseline at 3, 6, and 12 months. * Change from Baseline in mean leg pain at 3, 6, and 12 months * Percentage change from Baseline in mean leg pain at 3, 6, and 12 months
- Quality of life measure12 months
Change from baseline in quality of life at 3, 6 and 12 months will be assessed using the EQ-5D-5L questionnaire.
- Pain Inventory12 months
Change from baseline in pain symptoms at 3, 6 and 12 months assessed by 11-point BPI-DPN (Brief Pain Inventory for Diabetic Peripheral Neuropathy) pain scale, with 0 indicating no pain and 10 indicating worst pain.
- Global impression of change in health status12 months
The patient's general health status at 3, 6 and 12 months will be assessed both by the patients themselves as well as the study investigators using the 7-point PGIC (Patient Global Impression of Change) and the CGIC (Clinician Global Impression of Change) instrument respectively. Responses for this questionnaire range from "no change (or condition has got worse)" to "a great deal better".