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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bioness Inc
ClinicalTrials.gov Identifier:
NCT00567541
First received: December 3, 2007
Last updated: March 2, 2016
Last verified: March 2016
  Purpose
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.

Condition Intervention Phase
Shoulder Pain Chronic
Device: Battery Powered Microneuromodulator (BBPM)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Feasibility Study of the Bioness Battery-Powered Microneuromodulator (BBPM) to Treat Chronic Shoulder Pain in Chronic Post-Stroke Subjects

Further study details as provided by Bioness Inc:

Primary Outcome Measures:
  • Relief of Chronic Shoulder Pain [ Time Frame: From baseline to 48 week follow up ] [ Designated as safety issue: No ]
    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'.


Enrollment: 16
Study Start Date: June 2007
Study Completion Date: December 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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).
Other Name: Bioness Battery Powered Microneuromodulator
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.
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).
Other Name: Bioness Battery Powered Microneuromodulator

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.
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00567541

Locations
United States, California
Rancho Los Amigos National Rehabilitation Center
Downey, California, United States, 90242
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
United States, West Virginia
The Center for Pain Relief
Charleston, West Virginia, United States, 25301
Sponsors and Collaborators
Bioness Inc
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
  More Information

Responsible Party: Bioness Inc
ClinicalTrials.gov Identifier: NCT00567541     History of Changes
Other Study ID Numbers: CP-BBPM-001 
Study First Received: December 3, 2007
Results First Received: February 4, 2016
Last Updated: March 2, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Bioness Inc:
shoulder
pain
stroke
subluxation

Additional relevant MeSH terms:
Shoulder Pain
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 29, 2016