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

NCT00567541 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2016-04-01

Study results available
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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.

Conditions

  • Shoulder Pain Chronic

Interventions

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).

Sponsors & Collaborators

  • Bioness Inc

    lead INDUSTRY

Principal Investigators

  • Andrew Friedman, MD · Virginia Mason Seattle Main Clinic

  • Tim Deer, MD · The Center for Pain Relief

  • Ziyad Ayyoub, M.D. · Rancho Los Amigos National Rehabilitation Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2011-12-31
Completion
2012-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00567541 on ClinicalTrials.gov