- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00567541
An Implantable Microneuromodulator for the Treatment of Chronic Shoulder Pain in Chronic Post-Stroke Subjects (BBPM)
March 2, 2016 updated by: Bioness Inc
Feasibility Study of the Bioness Battery-Powered Microneuromodulator (BBPM) to Treat Chronic Shoulder Pain in Chronic Post-Stroke Subjects
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 Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Downey, California, United States, 90242
- Rancho Los Amigos National Rehabilitation Center
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Washington
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Seattle, Washington, United States, 98101
- Virginia Mason Medical Center
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West Virginia
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Charleston, West Virginia, United States, 25301
- The Center for Pain Relief
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18 years of age or older
- Chronic post-stroke duration greater than or equal to 6 months
- Unilateral hemiplegic shoulder pain persisting for ≥6 months
- Hemiparesis (shoulder abduction graded <5/5 on Manual Muscle Testing ipsilateral to the shoulder in which the subject has chronic pain
- Shoulder pain ≥ 6/10 (on 0-10 numeric rating scale (NRS) for worst pain in last week (BPI #12))
- Ability to give informed consent and understand study requirements
- Ability to quantify pain using a 0-10 numeric rating scale. (A screening tool will be used to ensure that participants can rate 3 common pain scenarios (mosquito bite, stubbed toe and broken bone) on a 0-10 NRS relative to each other.)
- Willing and able to understand and comply with all study-related procedures during the course of the study
- Motivated to maintain an accurate diary for the study duration
Exclusion Criteria:
- Hemineglect (i.e., extinguish to double simultaneous stimulation)
- Shoulder trauma or diagnosed shoulder pathology prior to stroke; history of any shoulder surgery, regardless of whether procedure preceded for followed stroke.
- Need to take >1 pain medication (opioid or non-opioid) for shoulder pain
- Regular use of pain medication for chronic pain other than shoulder pain
- Anticoagulated (taking warfarin or heparin, including fractionated heparin) or has a bleeding disorder
- Unable, per their prescribing physician, to stop antiplatelet medications (e.g., aspirin, ticlopidine (Ticlid), clopidogrel (Plavix), tirofiban (Aggrastat), and eptifibatide (Integrilin)) for at least 7 days prior to device implantation.
- Cardiac pacemaker
- Implanted neurostimulator (e.g., spinal cord, deep brain, vagus nerve) or implanted pump or infusion device
- Prosthetic heart valve or valvular heart disease requiring antibiotic prophylaxis
- History of cardiac arrhythmia with hemodynamic instability
- Uncontrolled seizures (> 1 seizure per month)
- Pregnant or plan on becoming pregnant during the study period
- Medical instability
- Currently require, or likely to require, diathermy
- Currently require, or anticipated to require, MRI within 8 weeks of projected device implantation date
- History of adverse reactions to local anesthetic (e.g., lidocaine)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Active BBPM stimulation
Therapeutic Stimulation is applied via the Battery Powered Microneuromodulator (BBPM) which is programmed to deliver set stimulation parameters with approximate frequency of 30 Hz, current 5mA for 200 microseconds for the first 12 weeks of the study.
The BBPM is implanted near the axillary nerve within the quadrilateral space.
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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).
Other Names:
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Placebo Comparator: Sham BBPM stimulation
The Battery Powered Microneuromodulator is implanted near the axillary nerve within the quadrilateral space.
The BBPM is 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, the device will be reprogrammed to deliver therapeutic stimulation over a 12 week period.
|
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).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relief of Chronic Shoulder Pain
Time Frame: From baseline to 48 week follow up
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Brief Pain Inventory (BPI) Question # 12 (rating pain at its worst in week prior to visit) was used to measure number of participants in whom BBPM provided any relief from chronic shoulder pain after implantation, as evidence by appropriate muscular contraction and/or paresthesia.
BPI scale range is from 1 to 10, where 0 = 'no pain' and 10 = 'pain as bad as one can imagine'.
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From baseline to 48 week follow up
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- 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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2007
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
December 3, 2007
First Submitted That Met QC Criteria
December 3, 2007
First Posted (Estimate)
December 5, 2007
Study Record Updates
Last Update Posted (Estimate)
April 1, 2016
Last Update Submitted That Met QC Criteria
March 2, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CP-BBPM-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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