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

Mayo Clinic

Status: Completed

Conditions: Painful Diabetic Neuropathy

Treatments: Device: High Frequency Spinal Cord Stimulator

Study type: Interventional

Funder types: Other

Identifiers

NCT03769675

17-004317

Details and patient eligibility

About

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?

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes mellitus
• Refractory predominantly lower extremity neuropathic pain for > 1 year
• Presence of length dependent peripheral neuropathy on sudomotor testing
• Completed spinal cord stimulation trial with 40% or greater pain reduction from baseline
• Failed medication trials or contraindication to gabapentin medications (gabapentin, pregabalin) and/or serotonin/norepinephrine reuptake inhibitors (tricyclic antidepressant (TCA) or duloxetine or venlafaxine)
• Average pain score on a visual analog scale (VAS) of ≥ 5 (with 0 representing no pain and 10 the worst pain imaginable)
• Appropriate surgical candidate for spinal cord stimulator

Exclusion criteria

• Severe Autonomic Neuropathy as measured by the composite autonomic scoring scale (10 point scale) with a score ≥ 7
• History of sympathectomy
• Uncontrolled arterial hypertension (Systolic Blood Pressure >160)
• Baseline Foot TcPO2 < 10 mmHg to exclude patients with severe peripheral arterial disease
• Hemoglobin A1c > 8%
• Stable opioid regimen with oral morphine equivalent ≥ 100 mg/day
• Alternative principle cause for peripheral neuropathy or lower extremity neuropathic pain
• Disruptive psychiatric disorder (screened for during preoperative psychiatric evaluation)
• Pending litigations
• Women of child bearing potential unwilling to use contraception or found to be pregnant as part of perioperative screening
• Patients unable to hold medications that would impact autonomic testing

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Spinal Cord Stimulator Implant

Experimental group

Description:

Spinal Cord Stimulator implant

Treatment:

Device: High Frequency Spinal Cord Stimulator