Electrical Stimulation for the Treatment of Chronic Post-Stroke Shoulder Pain Using the Smartpatch System
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Orthopedic |
| Therapuetic Areas: | Neurology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 10/18/2017 |
| Start Date: | April 2013 |
| End Date: | November 14, 2016 |
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).
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
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Rehabilitation Institute of Chicago The Rehabilitation Institute of Chicago (RIC) is an independent, 501(c)3, non-profit...
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The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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