Electrical Stimulation for the Treatment of Post-Stroke Shoulder Pain

Post-stroke shoulder pain is defined as pain in the shoulder area that starts after a person
has had a stroke. The SPR System is an investigational device that is being studied for the
relief of post-stroke shoulder pain. The SPR System uses electrical stimulation and includes
a Trial Stage (where a temporary system is used to see if the subject may benefit from this
type of therapy) and may include an Implant Stage (where a small device is implanted under
the skin in the chest). The SPR System delivers mild electrical stimulation to the shoulder
where the subject feels pain. This research study will evaluate the effect of electrical
stimulation on shoulder pain.

Individuals who are over the age of 21, who had a stroke at least six months ago, who
experience shoulder pain, and have tried other therapies for their shoulder pain, may be
eligible to participate in the first stage of the SPR System. Subjects meeting the specified
success criteria at the conclusion of the SPR Trial Stage who experience a return of pain
within 6 months of completion of the Trial Stage may be eligible for the second stage (SPR
Implant Stage). This research study lasts a little over 3 years and may include 17 visits to
the study doctor and at least 8 telephone calls from study staff.