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

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.

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)