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Diabetic PolyneuropathyNCT01536236

Spinal Cord Stimulation for Diabetic Polyneuropathy

A study testing ANS Eon™ Implantable Pulse Generator (Permanent Implant) in people with Diabetic Polyneuropathy, run by Abbott Medical Devices at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Polyneuropathy
What is being tested?
ANS Eon™ Implantable Pulse Generator (Permanent Implant)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteUnited States
Study dates
Oct 2011to Oct 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The subject is 18 years of age or older
  • The subject has signed and received a copy of an informed consent form after the nature of the study has been fully explained.
  • The subject has a clinical diagnosis of diabetes mellitus
  • The subject has an A1C less than or equal to 10% within the last 3 months.
  • The subject has been on a stable diabetic therapy for at least 3 months without hospitalizations for control of diabetes.
  • The subject has a documented clinical diagnosis of painful diabetic distal symmetric sensory/motor polyneuropathy using the LANSS (Leeds assessment of neuropathic symptoms and signs) pain scale score of 12 or greater and the TNS (total neuropathy score) score of 20 or greater.
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  • The subject has bilateral, moderate to severe pain from diabetic polyneuropathy for the previous 3 months.
  • The subject has a VAS of > 4 at Baseline, on a stable analgesic regimen consisting of any one or combination of the following agents: anticonvulsants, antidepressants, and opioids for 1 month.
  • The subject has been shown to be refractory to conservative therapy by failing a minimum of 3 conservative treatments at least one of which is a medication specifically for diabetic polyneuropathy of adequate dose and duration
  • Female subject has a negative pregnancy test.

Who cannot join

  • Subject is unwilling or unable, in the opinion of the investigator, to comply with study instructions.
  • Subject has other severe pain that could confound the assessment of pain due to diabetic polyneuropathy.
  • Subject has a neuropathy that the investigator considers is not due to diabetes (e.g., significant vasculitis, collagen vascular disorder, medications known to cause neuropathies, history of familial neuropathy, drug or alcohol abuse, hepatitis, HIV, infection or pernicious anemia)
  • Subject has had any amputation.
  • Subject has a diagnosis within the past 1 year of major psychiatric disturbance. Exclusionary psychiatric diagnoses include the following Axis I disorders (DSM-IVR criteria): major depression, bipolar disorder, schizophrenia or other psychotic disorder or somatoform disorders. The Axis II disorder of borderline personality is also excluded.
  • Subject has co-existent, major systemic disease(s) that would interfere with interpretation of study results (e.g. malignancy, poorly controlled diabetes, ischemic cardiac disease, profound autonomic dysfunction or any other disease in the opinion of the investigator.)
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  • Subject who has an abnormal PT, PTT, bleeding time or platelet count that might interfere with therapy.
  • Subject is currently participating in or has, within the past 30 days, participated in a study of another investigational drug or device.
  • Subject has a history of substance abuse within the past 2 years.
  • Subject has a demand-type pacemaker or implanted cardiac defibrillator.
  • Subject who require diathermy or MRIs.
  • Subject with any metallic implants that might interfere with this therapy in the opinion of the investigator;
  • Subject who has an implanted medication pump or implanted neurostimulation device.
  • Subject who currently has an active infection.
  • Subject who currently has foot ulcers.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Midwest Neurosurgery Associates

    Kansas City, Missouri, 64132

Other trials in United States

About this study

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

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.

Read the detailed description

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.

Being tested
ANS Eon™ Implantable Pulse Generator (Permanent Implant), Placebo
Keywords
Diabetes, Polyneuropathy, Spinal cord stimulation
Medical subject headings
Diabetic Neuropathies, Diabetes Mellitus, Polyneuropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ANS Eon™ Implantable Pulse Generator (Permanent Implant)Device

    Appropriate programming based on subject's preference of programs.

  • PlaceboDevice

    Placebo

Study groups in NCT01536236
Study groupRoleWhat they receive
Subthreshold programmingActive comparatorDuring 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.
Receives: Device: ANS Eon™ Implantable Pulse Generator (Permanent Implant)
Placebo or Stimulation off armPlacebo comparatorDuring 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.
Receives: Device: ANS Eon™ Implantable Pulse Generator (Permanent Implant); Device: Placebo
Optimal stimulation programmingActive comparatorDuring the third week of the trial period, all subjects will receive optimal stimulation.
Receives: Device: ANS Eon™ Implantable Pulse Generator (Permanent Implant)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual Analog Scale (VAS)

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

    Measured: 24 months

Secondary outcomes (7)

  1. Device related and serious adverse events

    All adverse events that are classified as device related and/or serious will be assessed.

    Measured: 24 months +/- 6 months depending on study arm randomization

  2. 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.

    Measured: 24 months

  3. 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.

    Measured: 24 months

  4. 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.

    Measured: 24 months

  5. 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.

    Measured: 24 months

  6. Intra-epidermal skin biopsy

    A skin biopsy will be performed to assess damage to nerve fibers due to DPN.

    Measured: 24 months

  7. 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.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2012 (estimated)
  2. Study startOct 2011
  3. Primary completionOct 2014 (estimated)
  4. Study completionOct 2014 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01536236
Sponsor's protocol ID
CRD_505
Status last verified
Jan 2019
First submitted
17 Oct 2011
Last updated
30 Jan 2019
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing ANS Eon™ Implantable Pulse Generator (Permanent Implant) in people with Diabetic Polyneuropathy, run by Abbott Medical Devices at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analog Scale (VAS) (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01536236.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2019.

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