An interventional study of ANS Eon™ Implantable Pulse Generator (Permanent Implant) and Placebo in Diabetic Polyneuropathy, sponsored by Abbott Medical Devices. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-30.
Sponsored by Abbott Medical Devices · Not applicable, Interventional, and Treatment
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.
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.
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Exclusion Criteria:
During one of the first 2 weeks of the trial the subject will be randomized to a subthreshold stimulation arm. They will be blinded and receiving therapy, but will it will be delivered at a level (subthreshold) that they will not feel the stimulation.
Device: ANS Eon™ Implantable Pulse Generator (Permanent Implant)
During one of the first two weeks of the study, the patient will be randomized to a no stimulation arm. They will be blinded and will not be receiving therapy.
Device: ANS Eon™ Implantable Pulse Generator (Permanent Implant) · Device: Placebo
During the third week of the trial period, all subjects will receive optimal stimulation.
Device: ANS Eon™ Implantable Pulse Generator (Permanent Implant)
Appropriate programming based on subject's preference of programs.
Placebo
Visual Analog Scale (VAS)
The VAS is a 100mm line that indicates severity of pain progression
Time frame: 24 months
Device related and serious adverse events
All adverse events that are classified as device related and/or serious will be assessed.
Time frame: 24 months +/- 6 months depending on study arm randomization
Neuropathy Impairment in the Lower Limbs (NIS-LL)
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.
Time frame: 24 months
Nerve conduction studies and Electromyogram (EMG)
Electromyography (EMG) is a technique for evaluating and recording the electrical activity of muscles. This test will be performed according to standard practice.
Time frame: 24 months
Inflammatory mediators (IL-6, IL-1β, and CRP)
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.
Time frame: 24 months
Vascular Doppler
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.
Time frame: 24 months
Intra-epidermal skin biopsy
A skin biopsy will be performed to assess damage to nerve fibers due to DPN.
Time frame: 24 months
Short Form 36 (SF-36) Quality of Life Questionnaire
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.
Time frame: 24 months
This study is withdrawn, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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