An Implantable Microstimulator for the Treatment of Chronic Shoulder Pain in Chronic Post-Stroke Subjects - Full Text View

Sponsor:	Bioness Inc
Information provided by (Responsible Party):	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:	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 Microstimulator (BBPM) to Treat Chronic Shoulder Pain in Chronic Post-Stroke Subjects

Further study details as provided by Bioness Inc:

Primary Outcome Measures:

The primary outcome measure will be the feasibility of using the BBPM for treatment of chronic shoulder pain as evidenced by appropriate muscular contraction and/or paresthesias with no significant adverse events. [ Time Frame: From baseline to follow up ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Greater than 30% Pain Reduction measured by using Brief Pain Inventory (BPI #12) at each time point without increasing pain medication -Range of motion will be quantified using a goniometer -Motor functions will be measured by Fugl-Meyer Test [ Time Frame: From baseline to follow-up ] [ Designated as safety issue: No ]
Range of Motion: pain-free passive shoulder abduction, flexion and external rotation will be quantified. [ Time Frame: baseline to end of study ] [ Designated as safety issue: No ]
-Interference of shoulder pain in daily activities and function measured by using BPI#23 -Quality of Life assessed by using he EuroQol -Reported use of pain medication -Examined for shoulder subluxation -Examined for cutaneous shoulder sensation [ Time Frame: baseline to end of study ] [ Designated as safety issue: Yes ]

Enrollment:	16
Study Start Date:	June 2007
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Therapeutic Stim Grp The BBPM is programmed to deliver set therapeutic stimulation parameters for the first 12 weeks of the study.	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.
Placebo Comparator: Sham Stim Grp 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.

Detailed Description:

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

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

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

No publications provided

Responsible Party:	Bioness Inc
ClinicalTrials.gov Identifier:	NCT00567541 History of Changes
Other Study ID Numbers:	CP-BBPM-001
Study First Received:	December 3, 2007
Last Updated:	November 14, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bioness Inc:

shoulder
pain
stroke
subluxation

Additional relevant MeSH terms:

Shoulder Pain
Stroke
Cerebral Infarction
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Signs and Symptoms

Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on February 12, 2012