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

NCT ID: NCT03769675

Last Updated: 2023-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-20
• Study Completion Date: 2022-04-15

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Spinal Cord Stimulator Implant

Spinal Cord Stimulator implant

Group Type: EXPERIMENTAL

High Frequency Spinal Cord Stimulator

Intervention Type: DEVICE

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. .

Interventions

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. .

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Narayan R. Kissoon

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Narayan R Kissoon

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

References

Kissoon NR, LeMahieu AM, Stoltenberg AD, Bendel MA, Lamer TJ, Watson JC, Sletten DM, Singer W. Quantitative assessment of painful diabetic peripheral neuropathy after high-frequency spinal cord stimulation: a pilot study. Pain Med. 2023 Oct 13;24(Suppl 2):S41-S47. doi: 10.1093/pm/pnad087.

Reference Type: DERIVED

PMID: 37833046 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

17-004317

Identifier Type: -

Identifier Source: org_study_id