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

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ClinicalTrials.gov Identifier: NCT03769675
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
Narayan R. Kissoon, Mayo Clinic

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?

Condition or disease Intervention/treatment Phase
Painful Diabetic Neuropathy Device: High Frequency Spinal Cord Stimulator Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Quantitative Assessment of Painful Diabetic Peripheral Neuropathy After High Frequency Spinal Cord Stimulation: (QUANT) HF10 Study
Actual Study Start Date : November 20, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Spinal Cord Stimulator Implant
Spinal Cord Stimulator implant
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. .




Primary Outcome Measures :
  1. Change in Pain Assessment [ Time Frame: Baseline through 1 year ]
    Change in 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.

  2. Neuropathy Symptoms and Change (NSC) Score [ Time Frame: Baseline through 1 year ]
    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.

  3. Change in Oswestry Disability Index [ Time Frame: Baseline through 1 year ]
    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.

  4. Change in Neuropathy Impairment Score [ Time Frame: Baseline through 1 year ]
    Scores neuropathic deficits using a scale of 0-4 (zero=normal, 4=paralysis) to measure muscle weakness

  5. Change in Lower Limb Function Test [ Time Frame: Baseline through 1 year ]
    Test for lower limb function in which the subject will need to walk on toes, walk on heels, and arise from kneeled positon, each test is marked as not applicable, normal or abnormal.

  6. Modified Leads Assessment of Neuropathic Symptoms and Signs [ Time Frame: Baseline through 1 year ]
    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.

  7. Change in Pain [ Time Frame: 1 month through 9 month ]
    Numeric Rating Scale used to assess pain from a scale of 0 (no pain) to 10 (worst possible pain)


Secondary Outcome Measures :
  1. Change in Patient Health Questionnaire [ Time Frame: Baseline through 1 year ]
    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. A total score of 1-4=minimal depression, 5-9=mild depression, 10-14=moderate depression, 15-19=moderately severe depression, 20-27=severe depression

  2. Change in Height [ Time Frame: Baseline and 1 year ]
    calculated height in centimeters

  3. Change in Weight [ Time Frame: Baseline and 1 year ]
    calculated weight in kilograms

  4. Change in Body mass index [ Time Frame: Baseline and 1 year ]
    calculated as weight in kilograms divided by height in meters squared. Uses measurements of height and weight obtained during study (with appropriate metric conversions)

  5. Change in Hemoglobin A1c [ Time Frame: Baseline and 1 year ]
    A1C is the percent of red blood cell hemoglobin with glucose attached to it and an indicator of average blood glucose over the previous two to three months.

  6. Change in Q-SWEAT [ Time Frame: Baseline through 1 year ]
    Test that measures the rate and volume of sweat to determine the severity and pattern of autonomic disorders.

  7. Change in Laser Doppler Flowmetry [ Time Frame: Baseline through 1 year ]
    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).

  8. Change in Nerve Conduction [ Time Frame: Baseline through 1 year ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03769675


Locations
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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Anita D Stoltenberg, RRT, MHA    507-422-0582    Stoltenberg.Anita@mayo.edu   
Contact: Lavonne M Liedl, RRT    866-265-9263    Liedl.Lavonne@mayo.edu   
Principal Investigator: Narayan R Kissoon, M.D.         
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Narayan R Kissoon Mayo Clinic

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Responsible Party: Narayan R. Kissoon, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03769675     History of Changes
Other Study ID Numbers: 17-004317
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Narayan R. Kissoon, Mayo Clinic:
spinal cord stimulation
type 2 diabetes

Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Pain
Diabetic Neuropathies
Neuromuscular Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases