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Spinal Cord Stimulation for Diabetic Polyneuropathy

Primary Purpose

Diabetic Polyneuropathy

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ANS Eon™ Implantable Pulse Generator (Permanent Implant)
Placebo
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Polyneuropathy focused on measuring Diabetes, Polyneuropathy, Spinal cord stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. The subject is 18 years of age or older
  2. The subject has signed and received a copy of an informed consent form after the nature of the study has been fully explained.
  3. The subject has a clinical diagnosis of diabetes mellitus
  4. The subject has an A1C less than or equal to 10% within the last 3 months.
  5. The subject has been on a stable diabetic therapy for at least 3 months without hospitalizations for control of diabetes.
  6. 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.
  7. The subject has bilateral, moderate to severe pain from diabetic polyneuropathy for the previous 3 months.
  8. 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.
  9. 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
  10. Female subject has a negative pregnancy test.

Exclusion Criteria:

  1. Subject is unwilling or unable, in the opinion of the investigator, to comply with study instructions.
  2. Subject has other severe pain that could confound the assessment of pain due to diabetic polyneuropathy.
  3. 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)
  4. Subject has had any amputation.
  5. 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.
  6. 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.)
  7. Subject who has an abnormal PT, PTT, bleeding time or platelet count that might interfere with therapy.
  8. Subject is currently participating in or has, within the past 30 days, participated in a study of another investigational drug or device.
  9. Subject has a history of substance abuse within the past 2 years.
  10. Subject has a demand-type pacemaker or implanted cardiac defibrillator.
  11. Subject who require diathermy or MRIs.
  12. Subject with any metallic implants that might interfere with this therapy in the opinion of the investigator;
  13. Subject who has an implanted medication pump or implanted neurostimulation device.
  14. Subject who currently has an active infection.
  15. Subject who currently has foot ulcers.

Sites / Locations

  • Midwest Neurosurgery Associates

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

Subthreshold programming

Placebo or Stimulation off arm

Optimal stimulation programming

Arm Description

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.

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.

During the third week of the trial period, all subjects will receive optimal stimulation.

Outcomes

Primary Outcome Measures

Visual Analog Scale (VAS)
The VAS is a 100mm line that indicates severity of pain progression

Secondary Outcome Measures

Device related and serious adverse events
All adverse events that are classified as device related and/or serious will be assessed.
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.
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.
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.
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.
Intra-epidermal skin biopsy
A skin biopsy will be performed to assess damage to nerve fibers due to DPN.
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.

Full Information

First Posted
October 17, 2011
Last Updated
January 28, 2019
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT01536236
Brief Title
Spinal Cord Stimulation for Diabetic Polyneuropathy
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Withdrawn
Study Start Date
October 2011 (undefined)
Primary Completion Date
October 2014 (Anticipated)
Study Completion Date
October 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Polyneuropathy
Keywords
Diabetes, Polyneuropathy, Spinal cord stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Subthreshold programming
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo or Stimulation off arm
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Optimal stimulation programming
Arm Type
Active Comparator
Arm Description
During the third week of the trial period, all subjects will receive optimal stimulation.
Intervention Type
Device
Intervention Name(s)
ANS Eon™ Implantable Pulse Generator (Permanent Implant)
Intervention Description
Appropriate programming based on subject's preference of programs.
Intervention Type
Device
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS)
Description
The VAS is a 100mm line that indicates severity of pain progression
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Device related and serious adverse events
Description
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
Title
Neuropathy Impairment in the Lower Limbs (NIS-LL)
Description
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
Title
Nerve conduction studies and Electromyogram (EMG)
Description
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
Title
Inflammatory mediators (IL-6, IL-1β, and CRP)
Description
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
Title
Vascular Doppler
Description
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
Title
Intra-epidermal skin biopsy
Description
A skin biopsy will be performed to assess damage to nerve fibers due to DPN.
Time Frame
24 months
Title
Short Form 36 (SF-36) Quality of Life Questionnaire
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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. Exclusion Criteria: 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.) 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roni Diaz
Organizational Affiliation
Abbott Medical Devices
Official's Role
Study Director
Facility Information:
Facility Name
Midwest Neurosurgery Associates
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States

12. IPD Sharing Statement

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Spinal Cord Stimulation for Diabetic Polyneuropathy

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