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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Polyneuropathy

Interventions

Type	Name	Description
DEVICE	ANS Eon™ Implantable Pulse Generator (Permanent Implant)	Appropriate programming based on subject's preference of programs.
DEVICE	Placebo	Placebo

Timeline

• Start date: 2011-10-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2012-02-20
• Last updated: 2019-01-30

Locations

1 site across 1 country: United States