Electrical Stimulation for the Treatment of Post-Stroke Shoulder Pain
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.
Trial Stage Inclusion Criteria:

 -  At least 21 years of age

 -  Post-stroke shoulder pain

 Trial Stage Exclusion Criteria:

 -  Use of habit-forming (narcotic) medications

 -  History of recurrent skin infections

 -  Bleeding disorder

 -  Parkinson's Disease, Spinal Cord Injury, traumatic brain injury, Multiple Sclerosis,
 or complex regional pain syndrome

 -  Heart arrhythmia or artificial heart valves

 -  Uncontrolled seizures

 -  Implanted Electronic Device

 Implant Stage Inclusion Criteria

 -  Had a "return of pain" defined as an increase in pain of at least 2 points compared to
 the pain intensity score at Visit 5 and has a pain intensity score of at least 4