Clinical trial NCT03769675: Quantitative Assessment of Painful Diabetic Peripheral Neuropathy After High Frequency Spinal Cord Stimulation
Official title: Quantitative Assessment of Painful Diabetic Peripheral Neuropathy After High Frequency Spinal Cord Stimulation: (QUANT) HF10 Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Painful Diabetic Neuropathy
Keywords: spinal cord stimulation
type 2 diabetes
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-12-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain Assessment
timeFrame: Baseline, 12 months
measure: Neuropathy Symptoms and Change (NSC) Score
timeFrame: baseline, 12 months
measure: Oswestry Disability Index
timeFrame: Baseline, 12 months
measure: Neuropathy Impairment Score (NIS)
timeFrame: Baseline, 12 months
measure: Lower Limb Function Test
timeFrame: Baseline, 12 months
measure: Modified Leads Assessment of Neuropathic Symptoms and Signs
timeFrame: baseline, 12 months
measure: Positive Pain
timeFrame: baseline, 12 months
Secondary outcomes:
measure: Patient Health Questionnaire
timeFrame: Baseline, 12 months
measure: Height
timeFrame: Baseline, 12 months
measure: Weight
timeFrame: Baseline, 12 months
measure: Body Mass Index (BMI)
timeFrame: Baseline, 12 months
measure: Hemoglobin A1c
timeFrame: Baseline, 12 months
measure: Forearm Sweat Volume Quantitative Axon Reflex Sweat Test (Q-SWEAT)
timeFrame: baseline, 12 months
measure: Proximal Leg Laser Doppler Flowmetry (LDF)
timeFrame: Baseline, 12 months
measure: Extensor Digitorum Brevis Muscle Nerve Conduction
timeFrame: Baseline, 12 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Narayan R Kissoon
role: PRINCIPAL_INVESTIGATOR
References: