Electrical Stimulation for the Treatment of Chronic Post-Stroke Shoulder Pain Using the Smartpatch System
NCT ID: NCT01847885
Last Updated: 2017-10-16
Study Results
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View full resultsBasic Information
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COMPLETED
NA
88 participants
INTERVENTIONAL
2013-04-30
2016-11-14
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Smartpatch Treatment Group
Subjects in the Treatment Group will have a Smartpatch Lead placed in the shoulder, will use the Smartpatch Peripheral Nerve Stimulation (PNS) System, and will receive electrical stimulation.
Smartpatch Peripheral Nerve Stimulation (PNS) System
The Smartpatch System is an Investigation Device which 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).
Smartpatch Control Group
Subjects in the Control Group will have a Smartpatch Lead placed in the shoulder, will use the Smartpatch Peripheral Nerve Stimulation (PNS) System, but will not receive any electrical stimulation.
Smartpatch Peripheral Nerve Stimulation (PNS) System
The Smartpatch System is an Investigation Device which 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).
Interventions
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Smartpatch Peripheral Nerve Stimulation (PNS) System
The Smartpatch System is an Investigation Device which 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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Post-stroke shoulder pain
* At least 6 months after stroke that caused shoulder pain
Exclusion Criteria
* 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
21 Years
ALL
No
Sponsors
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SPR Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Rehabilitation Institute of Chicago
Chicago, Illinois, United States
Kessler Foundation Research Center
West Orange, New Jersey, United States
Weill Cornell Medical Center
New York, New York, United States
Carolinas Rehabilitation/Carolinas Healthcare
Charlotte, North Carolina, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Countries
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Other Identifiers
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0131-CSP-000
Identifier Type: -
Identifier Source: org_study_id