- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01536236
Spinal Cord Stimulation for Diabetic Polyneuropathy
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Missouri
-
Kansas City, Missouri, United States, 64132
- Midwest Neurosurgery Associates
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Subthreshold programming
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.
|
Appropriate programming based on subject's preference of programs.
|
PLACEBO_COMPARATOR: Placebo or Stimulation off arm
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.
|
Placebo
Appropriate programming based on subject's preference of programs.
|
ACTIVE_COMPARATOR: Optimal stimulation programming
During the third week of the trial period, all subjects will receive optimal stimulation.
|
Appropriate programming based on subject's preference of programs.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analog Scale (VAS)
Time Frame: 24 months
|
The VAS is a 100mm line that indicates severity of pain progression
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
24 months +/- 6 months depending on study arm randomization
|
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. |
24 months
|
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.
|
24 months
|
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.
|
24 months
|
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.
|
24 months
|
Intra-epidermal skin biopsy
Time Frame: 24 months
|
A skin biopsy will be performed to assess damage to nerve fibers due to DPN.
|
24 months
|
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.
|
24 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRD_505
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Ilko Ilac San. ve Tic. A.S.CompletedPeripheral (Sensorimotor) Diabetic Polyneuropathy
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