Clinical Trial: Spinal Cord Stimulation for Diabetic Polyneuropathy

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: A Randomized, Comparison Study of the Safety and Efficacy of Spinal Cord Stimulation Versus Standard of Care Medical Management in the Treatment of Diabetic Polyneuropathy

Brief Summary: To obtain preliminary estimates of the safety and efficacy of the ANS Eon™ Implantable Pulse Generator with ANS leads in the treatment of subjects with diabetic polyneuropathy.

Detailed Summary: There is a medication arm and a stimulation arm. Patients will randomized to one or the other. If patients are randomized to the medication arm, after 6 months they have the option of going into the stimulation arm. There is a 3 week trial which includes a crossover period from "no stimulation" to subthreshold stimulation. The 3rd week patients will receive "optimal" stimulation. If they qualify, they will be implanted with the permanent device.
Sponsor: St. Jude Medical

Current Primary Outcome: Visual Analog Scale (VAS) [ Time Frame: 24 months ]

The VAS is a 100mm line that indicates severity of pain progression


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Device related and serious adverse events [ Time Frame: 24 months +/- 6 months depending on study arm randomization ]
    All adverse events that are classified as device related and/or serious will be assessed.
  • Neuropathy Impairment in the Lower Limbs (NIS-LL) [ Time Frame: 24 months ]

    Neuropathy Impairment Score in the Lower Limbs (NIS-LL):

    The NIS-LL is a quantitative neurological examination that evaluates changes in motor, sensory and reflex activity in the lower limbs. The test has 14 items: 8 to evaluate muscle strength (64 possible points), 2 items to evaluate reflex activity (8 possible points), and 4 items to evaluate sensory activity (16 possible points). All items are tested bilaterally and the maximum score is 88 points.

  • Nerve conduction studies and Electromyogram (EMG) [ Time Frame: 24 months ]
    Electromyography (EMG) is a technique for evaluating and recording the electrical activity of muscles. This test will be performed according to standard practice.
  • Inflammatory mediators (IL-6, IL-1β, and CRP) [ Time Frame: 24 months ]
    A complete blood count (CBC), comprehensive metabolic panel (CMP) and PT, (Prothrombin Time), PTT (Partial Thromboplastin Time) will be performed as well as assessment of hemoglobin A1c (HbA1c), interleukin-6 (IL-6), interleukin-1 beta (IL-1β), and C-reactive protein (CRP) levels. HbA1c is used to evaluate the amount of glycosylated hemoglobin in the blood which is indicative of blood glucose levels. IL-6 and IL-1β, and CRP are indicators of an inflammatory response and are consistently associated with diabetic polyneuropathy.
  • Vascular Doppler [ Time Frame: 24 months ]
    A Doppler ultrasound uses reflected sound waves to evaluate blood as it flows through the major arteries and veins of the arms, legs, and neck. This test will be performed according to standard practice.
  • Intra-epidermal skin biopsy [ Time Frame: 24 months ]
    A skin biopsy will be performed to assess damage to nerve fibers due to DPN.
  • Short Form 36 (SF-36) Quality of Life Questionnaire [ Time Frame: 24 months ]
    The SF-36 is a 36-item tool for measuring health related quality of life from the patient's point of view. The items on the questionnaire are scored and divided into 8 sub-scales, and each subscale is also categorized as a physical component or a mental component.


Original Secondary Outcome: Same as current

Information By: St. Jude Medical

Dates:
Date Received: October 17, 2011
Date Started: October 2011
Date Completion: October 2014
Last Updated: March 20, 2015
Last Verified: March 2015