An Implantable Microneuromodulator for the Treatment of Chronic Shoulder Pain in Chronic Post-Stroke Subjects
Condition: Shoulder Pain Chronic
MeSH terms: Shoulder Pain
Intervention: Battery Powered Microneuromodulator (BBPM)
Intervention description: 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).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: shoulder; pain; stroke; subluxation

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.
    

Eligibility 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)