Spinal Cord Stimulation for Diabetic Polyneuropathy

NCT01536236 | Withdrawn

• 1 other identifier: CRD_505
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Polyneuropathy

Keywords

Diabetes; Polyneuropathy; Spinal cord stimulation

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale (VAS)

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

  24 months

Secondary Outcomes (7)

• Device related and serious adverse events

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

• Neuropathy Impairment in the Lower Limbs (NIS-LL)

  24 months

• Nerve conduction studies and Electromyogram (EMG)

  24 months

• Inflammatory mediators (IL-6, IL-1β, and CRP)

  24 months

• Vascular Doppler

  24 months

Study Arms (3)

Subthreshold programming

ACTIVE COMPARATOR

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)

Placebo or Stimulation off arm

PLACEBO COMPARATOR

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

Optimal stimulation programming

ACTIVE COMPARATOR

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

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

Interventions

ANS Eon™ Implantable Pulse Generator (Permanent Implant) DEVICE

Appropriate programming based on subject's preference of programs.

Optimal stimulation programming; Placebo or Stimulation off arm; Subthreshold programming

Placebo DEVICE

Placebo

Placebo or Stimulation off arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

Midwest Neurosurgery Associates

Kansas City, Missouri, 64132, United States

Location

MeSH Terms

Conditions

Diabetic Neuropathies; Diabetes Mellitus; Polyneuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Roni Diaz

  Abbott Medical Devices

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2011
• First Posted: February 20, 2012
• Study Start: October 1, 2011
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: January 30, 2019

Record last verified: 2019-01

Locations

US (1)