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| Sponsored by: |
Bioness Inc |
|---|---|
| Information provided by: | Bioness Inc |
| ClinicalTrials.gov Identifier: | NCT00567541 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Shoulder Pain in Chronic Post-Stroke |
Device: Bioness Battery Powered Microstimulator Device: Battery-Powered Microstimulator (BBPM) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Feasibility Study of the Bioness Battery-Powered Microstimulator (BBPM) to Treat Chronic Shoulder Pain in Chronic Post-Stroke Subjects |
| Estimated Enrollment: | 16 |
| Study Start Date: | June 2007 |
| Estimated Study Completion Date: | February 2010 |
| Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Therapeutic Stim Grp: Active Comparator
The BBPM is programmed to deliver set therapeutic stimulation parameters for the first 12 weeks of the study.
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Device: Bioness Battery Powered Microstimulator
The BBPM will be programmed for the first 12 weeks of the study to deliver electrical stimulation for treatment of post-stroke shoulder pain.
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Sham Stim Grp: Placebo Comparator
The BBPM will be programmed for the first 12 weeks of the study to deliver short bursts of extremely low amplitude electrical stimulation at very wide time intervals to give appearance, impression, and sensation of therapeutic treatment. After 24 weeks, they will be reprogrammed to receive therapeutic stimulation.
|
Device: Battery-Powered Microstimulator (BBPM)
The BBPM will be programmed for the first 12 weeks of the study to deliver short bursts of extremely low amplitude electrical stimulation at very wide time intervals to give appearance, impression, and sensation of therapeutic treatment. After 24 weeks, they will be reprogrammed to receive therapeutic stimulation.
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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.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Charina Icamen-Curry | (661) 362-6646 | charina.icamencurry@bioness.com |
| United States, California | |
| Rancho Los Amigos National Rehabilitation Center | Recruiting |
| Downey, California, United States, 90242 | |
| Contact: Robert Boucher, PA-C 562-401-6074 rboucher@dhs.lacounty.gov | |
| Principal Investigator: Ziyad Ayyoub, M.D. | |
| Sub-Investigator: Vance Eberly, M.D. | |
| United States, Washington | |
| Virginia Mason Medical Center | Recruiting |
| Seattle, Washington, United States, 98101 | |
| Contact: Jill Zeller, RN 206-625-7373 ext 64841 jill.zeller@vmmc.org | |
| Principal Investigator: Andrew Friedman, MD | |
| United States, West Virginia | |
| The Center for Pain Relief | Recruiting |
| Charleston, West Virginia, United States, 25301 | |
| Contact: Diana Bowne, RN 304-347-6193 diana.bowne@sfth.net | |
| Principal Investigator: Tim Deer, MD | |
| Study Director: | Evan Rosenfeld, MD, JD | Bioness Inc |
| Principal Investigator: | Andrew Friedman, MD | Virginia Mason Seattle Main Clinic |
| Principal Investigator: | Tim Deer, MD | The Center for Pain Relief |
| Principal Investigator: | Ziyad Ayyoub, M.D. | Rancho Los Amigos National Rehabilitation Center |
More Information
| Responsible Party: | Bioness Inc. ( Evan L. Rosenfeld, MD, JD/Chief Medical Officer/VP, Medical & Regulatory Affairs ) |
| Study ID Numbers: | CP-BBPM-001 |
| Study First Received: | December 3, 2007 |
| Last Updated: | March 5, 2009 |
| ClinicalTrials.gov Identifier: | NCT00567541 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
shoulder pain stroke subluxation |
|
Cerebral Infarction Shoulder Pain Joint Diseases Stroke Vascular Diseases Central Nervous System Diseases Pain Ischemia |
Brain Diseases Cerebrovascular Disorders Signs and Symptoms Musculoskeletal Diseases Brain Ischemia Brain Infarction Infarction Arthralgia |
|
Cerebral Infarction Shoulder Pain Joint Diseases Stroke Nervous System Diseases Vascular Diseases Central Nervous System Diseases Pain |
Brain Diseases Cerebrovascular Disorders Signs and Symptoms Musculoskeletal Diseases Brain Ischemia Cardiovascular Diseases Brain Infarction Arthralgia |