- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Spinal Cord Stimulator Implant
Spinal Cord Stimulator implant
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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. .
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Assessment
Time Frame: Baseline, 12 months
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Pain measurement using a Visual Analog Pain Scale by placing an X in the box to indicate the severity of pain from no pain to intolerable pain.
The X in the box translates to a score of zero for no pain and increases by an additional 0.5 up to a high score of 10 which would be intolerable pain.
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Baseline, 12 months
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Neuropathy Symptoms and Change (NSC) Score
Time Frame: baseline, 12 months
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Validated questionnaire that evaluates change in neuropathy symptoms, including symptoms of weakness, sensory symptoms, and autonomic symptoms.
Answers to questionnaire are yes/no and if yes, then degree of severity is evaluated with a plus one(slight), plus two (moderate) and plus three (severe).
Questionnaire screens the presence and severity of diabetic peripheral neuropathy.
Change in severity of symptoms are compared over time.
Total scores range from 0 - 114, lower scores reflect no neuropathy symptoms, higher scores reflect more neuropathy symptoms.
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baseline, 12 months
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Oswestry Disability Index
Time Frame: Baseline, 12 months
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Questionnaire examines perceived level of disability in 10 everyday activities of daily living including pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life and traveling.
The 6 statements are scored from 0 to 5 scale, zero meaning no disability.
The final score ranges from 0-100 with a score of 0-20 equals minimal disability, 21-40 equals moderate disability, 41-60 equals severe disability, 61-80 equals crippled and 81-100 equals bed-bound.
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Baseline, 12 months
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Neuropathy Impairment Score (NIS)
Time Frame: Baseline, 12 months
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Subject's scores neuropathic deficits using a scale of 0-4 (zero=normal, 4=paralysis) to measure muscle weakness.
The NIS score is a measure of neurologic impairment.
The NIS Score has a range of 0 to 244.
Lower scores indicate higher function, higher scores indicate lower function.
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Baseline, 12 months
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Lower Limb Function Test
Time Frame: Baseline, 12 months
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Test for lower limb function in which the subject will need to walk on toes, walk on heels, and arise from kneeled position, each test is marked as not applicable, normal or abnormal.
The examination assesses each component for the left and right side separately.
If the test is normal, it is given a score of 0, and if it is abnormal, a score of 1.
Not applicable scores a zero.
Total scores range 0-6.
Therefore, the maximum score of 6 indicates abnormality in all 3 components bilaterally and a minimum score of 0 indicates a normal result for all 3 components bilaterally.
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Baseline, 12 months
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Modified Leads Assessment of Neuropathic Symptoms and Signs
Time Frame: baseline, 12 months
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Questionnaire to identify and analyze pain by answering yes/no which translates to scores from 0-24.
A score of 12 or more suggests pain of predominantly neuropathic origin.
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baseline, 12 months
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Positive Pain
Time Frame: baseline, 12 months
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Numeric Rating Scale used to assess pain from a scale of 0 (no pain) to 10 (worst possible pain)
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baseline, 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Health Questionnaire
Time Frame: Baseline, 12 months
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Screens for the presence and severity of depression with 9 questions in a scale of 0-3.
Zero=not at all, 1=several days, 2=more than half the days, 3=nearly every day.
Total score range 0 - 27.
A total score of 0-4=minimal depression, 5-9=mild depression, 10-14=moderate depression, 15-19=moderately severe depression, 20-27=severe depression
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Baseline, 12 months
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Height
Time Frame: Baseline, 12 months
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Subjects calculated height in centimeters.
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Baseline, 12 months
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Weight
Time Frame: Baseline, 12 months
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Subjects calculated weight in kilograms
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Baseline, 12 months
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Body Mass Index (BMI)
Time Frame: Baseline, 12 months
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Subject's BMI calculated as weight in kilograms divided by height in meters squared.
Uses measurements of height and weight obtained during study (with appropriate metric conversions)
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Baseline, 12 months
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Hemoglobin A1c
Time Frame: Baseline, 12 months
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Hemoglobin is a protein within red blood cells.
As glucose enters the bloodstream, it binds to hemoglobin, or glycates.
The more glucose that enters the bloodstream, the higher the amount of glycated hemoglobin.
An A1C level below 5.7 percent is considered normal.
Reported as percentage of glycated hemoglobin
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Baseline, 12 months
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Forearm Sweat Volume Quantitative Axon Reflex Sweat Test (Q-SWEAT)
Time Frame: baseline, 12 months
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Test that measures the rate and volume of sweat to determine the severity and pattern of autonomic disorders.
As measured by µL/cm²
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baseline, 12 months
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Proximal Leg Laser Doppler Flowmetry (LDF)
Time Frame: Baseline, 12 months
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Laser Doppler velocimetry is used in hemodynamics research as a technique to partially quantify blood flow in human tissues such as skin.
Within the clinical environment, the technology is often referred to as laser Doppler flowmetry (LDF).
As measured in perfusion units (p.u.)
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Baseline, 12 months
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Extensor Digitorum Brevis Muscle Nerve Conduction
Time Frame: Baseline, 12 months
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A nerve conduction study (NCS) is a medical diagnostic test commonly used to evaluate the function, especially the ability of electrical conduction, of the motor and sensory nerves of the human body.
As measured by amplitude (AMP) milliamp (mA)
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Baseline, 12 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Narayan R Kissoon, Mayo Clinic
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17-004317
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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