Status:
UNKNOWN
Safety and Effectiveness of Cortical Stimulation in the Treatment of Stroke Patients With Upper Extremity Hemiparesis
Lead Sponsor:
Northstar Neuroscience
Conditions:
Stroke
Hemiparesis
Eligibility:
All Genders
21+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the safety and effectiveness of cortical stimulation delivered concurrent with rehabilitation activities to enhance motor recovery in patients suffering from hem...
Detailed Description
Stroke is a leading cause of serious, long-term disability in the United States. According to the American Stroke Association, the prevalence of stroke in the U.S. is approximately 4.8 million with ap...
Eligibility Criteria
Inclusion
- Subjects must have an ischemic stroke.
- Moderate to moderately severe upper-extremity hemiparesis.
- Aged 21 years or older.
Exclusion
- Primary hemorrhagic stroke.
- Any additional stroke associated with incomplete motor recovery.
- Any neurologic or physical condition impairing function of the target extremity.
- History of seizure disorder.
- History of spinal cord injury, traumatic brain injury, or spontaneous subdural or epidural hematoma that has resulted in a neurologic deficit.
- Contraindication to magnetic resonance (MR) imaging.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2008
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT00170716
Start Date
September 1 2004
End Date
March 1 2008
Last Update
December 28 2007
Active Locations (21)
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1
University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724
2
University of Southern California
Los Angeles, California, United States, 90089
3
University of California San Francisco Medical Center
San Francisco, California, United States, 94125
4
Stanford University Medical Center
Stanford, California, United States, 94305