NCT05777317

Pain and Neurological Function Improvements With 10 kHz Spinal Cord Stimulation Treatment of Painful Diabetic Neuropathy

PDN-SENSORY: A Multi-Center Randomized Controlled Trial to Evaluate Pain and Neurological Function With 10 kHz SCS in Treatment of Painful Diabetic Neuropathy

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 143 (actual)
• Sponsor: Nevro Corp · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this post-market study is to evaluate changes in pain and neurological function with high frequency, 10 kHz spinal cord stimulation (SCS) therapy in patients with chronic, intractable lower limb pain associated with diabetic peripheral neuropathy, a condition known as painful diabetic neuropathy (PDN). This is a multi-center, prospective, randomized controlled study to evaluate improvement in pain and neurological function in PDN patients, with neurological function assessed via objective measures. Patients will be randomized to conventional medical management (CMM) or 10 kHz SCS plus CMM.

Conditions

• Painful Diabetic Neuropathy

Interventions

Type	Name	Description
DEVICE	10 kHz SCS	Spinal cord stimulation programmed to a frequency of 10 kHz
OTHER	CMM alone	Conventional medical management alone

Timeline

• Start date: 2023-04-24
• Primary completion: 2025-06-30
• Completion: 2026-08-31
• First posted: 2023-03-21
• Last updated: 2024-11-06

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study