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Spinal Cord Stimulation for Painful Diabetic Neuropathy (DPN)

This study has been terminated.
(Insufficient Data Collected)
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00487981
First received: June 15, 2007
Last updated: February 21, 2012
Last verified: February 2012
History of Changes
  Purpose

The purpose of this study is to evaluate Spinal Cord Stimulation (SCS) therapy in individuals who suffer from painful diabetic peripheral neuropathy. Patients invited to participate in this study will be eligible for SCS therapy, and will have already selected therapy with the Advanced Bionics Precision system independent of possible inclusion in this study. The device, accessories, and procedures associated with device placement and the indications for use are all consistent with the current and approved product labeling.


Condition Intervention Phase
Diabetic Neuropathy
Pain
Peripheral Neuropathy
 Device: Precision Spinal Cord Stimulation
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Precision Spinal Cord Stimulation for Painful Diabetic Neuropathy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Pain Rating at 6 Months Post Activation Compared to Baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: February 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Spinal Cord Stimulation Group
Spinal Cord Stimulation (SCS) Treatment Group
 Device: Precision Spinal Cord Stimulation
Stimulation on throughout the study once device is implanted
Other Name: Precision Spinal Cord Stimulation System

Detailed Description:

The management of neuropathic pain is often difficult, and the available treatment options rarely provide complete relief. Although prevention by means of glycemic control is the first priority, up to 20% of patients will develop Diabetic Peripheral Neuropathy (DPN) and require active drug therapy. Select anti-depressants, anti-epileptics, and opioids have generally been the first-line pharmacologic treatments for neuropathic pain. Topical creams have been used to achieve local control. Nonconventional therapies have included acupuncture and magnet therapy. However, all of these treatments have limited utility because of marginal efficacy. Various forms of electric stimulation have been shown to improve the symptoms of DPN. Advances in spinal cord stimulation technology have encouraged broader use of this treatment modality in the management of chronic painful DPN.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have chronic neuropathic pain in at least one limb with a score of at least 3 using the Michigan Neuropathy Screening Instrument (MNSI) secondary to Type 1 or Type 2 diabetes
  • Have chronic neuropathic pain for at least 12 months
  • Be 18 years of age or older
  • Be refractory to pain medication including gabapentin or the use of pain medication is contraindicated or not tolerated because of side effects or other medical condition
  • Be an appropriate candidate for SCS therapy and have already decided to use the Precision system
  • Be willing and able to comply with all study related procedures and visits
  • Be capable of reading and understanding patient information materials and giving written informed consent

Exclusion Criteria:

  • Are a smoker
  • Have any other chronic pain condition likely to confound evaluation of study endpoints
  • Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints such as peripheral vascular disease or neurological disorders unrelated to diabetic neuropathy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00487981

Locations
United States, Indiana
Deaconess Pain Management Center
Evansville, Indiana, United States, 47747
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Francis McDonnell, MD Deaconess Hospital
  More Information

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00487981     History of Changes
Other Study ID Numbers: SCS0206
Study First Received: June 15, 2007
Results First Received: February 13, 2012
Last Updated: February 21, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Boston Scientific Corporation:
Pain
Implantable stimulation device
Neuropathy

Additional relevant MeSH terms:
Diabetic Neuropathies
Peripheral Nervous System Diseases
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Neuromuscular Diseases
 Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Signs and Symptoms
Poisoning
Substance-Related Disorders

ClinicalTrials.gov processed this record on May 21, 2013