Electrical Stimulation for the Treatment of Chronic Post-Stroke Shoulder Pain Using the Smartpatch System

A Randomized, Double-Blinded, Placebo-Control Multicenter Pivotal Study of the Smartpatch Peripheral Nerve Stimulation (PNS) System for the Treatment of Chronic Post-Stroke Shoulder Pain

The purpose of this study is to determine if electrical stimulation (small levels of electricity) reduces post-stroke shoulder pain. This study involves a device called the Smartpatch System. The Smartpatch System delivers mild electrical stimulation to the muscles in the shoulder. The Smartpatch System includes a small wire (called a "Lead") that is placed through the skin into the muscle of the shoulder. It also includes a device worn on the body that delivers stimulation (called the Smartpatch Stimulator).

Key Inclusion Criteria:

• At least 21 years of age
• Post-stroke shoulder pain
• At least 6 months after stroke that caused shoulder pain

Key Exclusion Criteria:

• Use of habit-forming (narcotic) medications
• Bleeding disorder
• History of recurrent skin infections
• 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
• Pregnant