NCT03769675

Quantitative Assessment of Painful Diabetic Peripheral Neuropathy After High Frequency Spinal Cord Stimulation

Quantitative Assessment of Painful Diabetic Peripheral Neuropathy After High Frequency Spinal Cord Stimulation: (QUANT) HF10 Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Will participants with painful lower extremity diabetic peripheral neuropathy (DPN) that are treated with high frequency spinal cord stimulation (HF10 SCS) have improvements in lower extremity peripheral nerve function?

Detailed description

This research study is being conducted to find out if spinal cord stimulation (SCS) can improve nerve function. SCS is FDA approved for the treatment of intractable neuropathic (nerve) pain related to diabetic peripheral neuropathy. With SCS a wire is placed in the epidural space and the spinal cord is stimulated to interrupt the pain signal coming from the legs. The spinal cord stimulator is a device similar to a pacemaker (which helps treat abnormal rhythms of the heart). Recent studies have suggested that SCS with high frequencies can improve nerve function for subjects with painful peripheral neuropathy therefore, the investigators are looking to measure changes in nerve function after SCS for treatment of painful diabetic peripheral neuropathy. The purpose of this research is to gather information on the effect of high frequency spinal cord stimulation (HF10) on nerve function with a spinal cord stimulator.

Conditions

• Painful Diabetic Neuropathy

Interventions

Type	Name	Description
DEVICE	High Frequency Spinal Cord Stimulator	The SCS implant will follow standard clinical practice for these FDA approved indications. Two percutaneous leads will be placed in the posterior spinal epidural space under radiographic guidance and attached to either an external stimulator (trial phase) or a subcutaneously implanted impulse generator (IPG). Intraoperative impedance testing will be performed to ensure electrical integrity. Patients with HF10 SCS will receive 30 µs pulses delivered at 10,000 Hz with amplitude adjusted to optimal analgesic response. Programming will occur postoperatively and as needed based on patient feedback in standard clinic visits. .

Timeline

• Start date: 2018-11-20
• Primary completion: 2022-04-15
• Completion: 2022-04-15
• First posted: 2018-12-07
• Last updated: 2023-04-11
• Results posted: 2023-04-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study