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An Implantable Microstimulator for the Treatment of Chronic Shoulder Pain in Chronic Post-Stroke Subjects — BBPM  

Shoulder Pain Chronic Clinical Trial

Official title:
Feasibility Study of the Bioness Battery-Powered Microstimulator (BBPM) to Treat Chronic Shoulder Pain in Chronic Post-Stroke Subjects

Clinical Trial Summary

The goal of this research study is to investigate the safety and effectiveness of a new implanted device designed to treat chronic shoulder pain in chronic post-stroke subjects. The BBPM weighs less than 0.03 ounces and measures 1" x 0.1". It is implanted into the shoulder to stimulate the axillary nerve. Stimulation of this nerve may reduce shoulder pain, reduce shoulder subluxation, improve motion, improve function, and decrease use of pain medication. CAUTION--Investigational device. Limited by Federal law to investigational use.

Clinical Trial Description

This is a prospective, dual-center, randomized, controlled, double-blinded parallel study designed to evaluate the feasibility and safety of using the The primary purpose of this study is to demonstrate the clinical feasibility of implanting the BBPM near a peripheral nerve for the treatment of chronic, intractable, pain in this case represented by chronic regional shoulder pain in hemiplegic stroke patients. This is a 48-week study with a two-year follow up. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00567541
Study type Interventional
Source Bioness Inc
Contact
Status Completed
Phase Phase 2
Start date June 2007
Completion date December 2012
View Details
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