At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Feasibility Study of the Bioness Battery-Powered Microneuromodulator (BBPM) to Treat Chronic Shoulder Pain in Chronic Post-Stroke Subjects
In Brief
A Phase 2 clinical trial evaluating Battery Powered Microneuromodulator (BBPM) for Shoulder Pain Chronic. Completed, enrolled 16 participants across 3 sites.
Detailed 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.
Study Details
Timeline
Interventions
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).