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

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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
We found this trial at
5
sites
410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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Charlotte, North Carolina 28203
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345 E Superior St
Chicago, Illinois 60611
(312) 238-1000
Rehabilitation Institute of Chicago The Rehabilitation Institute of Chicago (RIC) is an independent, 501(c)3, non-profit...
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New York, New York 10065
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West Orange, New Jersey 07052
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West Orange, NJ
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