NCT00567541

An Implantable Microneuromodulator for the Treatment of Chronic Shoulder Pain in Chronic Post-Stroke Subjects

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Bioness Inc · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The goal of this research study is to investigate safety and gather initial effectiveness data for 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 possibly decrease use of pain medication. CAUTION--Investigational device. Limited by Federal law to investigational use.

Detailed description

This is a prospective, multi-center, randomized, controlled, double-blinded parallel study designed to evaluate feasibility and safety. 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 efficacy study with safety data collection throughout the study period and up to 2 years for all available subjects. Each study arm will receive therapeutic level stimulation for a total of 12 consecutive weeks (Weeks 1-12 for Active treatment group and Weeks 24-36 for the sham group) during the 48 weeks.

Conditions

• Shoulder Pain Chronic

Interventions

Type	Name	Description
DEVICE	Battery Powered Microneuromodulator (BBPM)	The Battery Powered Microneuromodulator (BBPM) is programmed to deliver bursts of electrical stimulation to deliver therapeutic stimulation beginning with a frequency of 30Hz, current of 5mA, for 200 microseconds. These settings were applied to deliver greater or lesser intensity based on study arm (active vs placebo).

Timeline

• Start date: 2007-06-01
• Primary completion: 2011-12-01
• Completion: 2012-12-01
• First posted: 2007-12-05
• Last updated: 2016-04-01
• Results posted: 2016-04-01

Locations

3 sites across 1 country: United States