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

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)