Spinal Cord Stimulation for Painful Diabetic Neuropathy

NCT00487981 | Terminated Phase 4 Results

• 1 other identifier: SCS0206
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Neuropathy; Pain; Peripheral Neuropathy

Keywords

Pain; Implantable stimulation device; Neuropathy

Outcome Measures

Primary Outcomes (1)

• Pain Rating at 6 Months Post Activation Compared to Baseline

  6 months

Study Arms (1)

Spinal Cord Stimulation Group

OTHER

Spinal Cord Stimulation (SCS) Treatment Group

Device: Precision Spinal Cord Stimulation

Interventions

Precision Spinal Cord Stimulation DEVICE

Stimulation on throughout the study once device is implanted

Also known as: Precision Spinal Cord Stimulation System

Spinal Cord Stimulation Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (1)

Deaconess Pain Management Center

Evansville, Indiana, 47747, United States

Location

MeSH Terms

Conditions

Diabetic Neuropathies; Pain; Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

One subject enrolled.

Results Point of Contact

• Title: Lyn M. Pimentel, M.B.A.
• Organization: Boston Scientific

Lyn.Pimentel@bsci.com

(661) 949-4174

Study Officials

• Francis McDonnell, MD

  Deaconess Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2007
• First Posted: June 19, 2007
• Study Start: February 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: March 13, 2012
• Results First Posted: March 13, 2012

Record last verified: 2012-02

Locations

US (1)