Safety and Effectiveness of Cortical Stimulation in the Treatment of Stroke Patients With Upper Extremity Hemiparesis
NCT ID: NCT00170716
Last Updated: 2007-12-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
174 participants
INTERVENTIONAL
2004-09-30
2008-03-31
Brief Summary
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Detailed Description
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The most common neurological deficit among these stroke survivors, and thus a substantial contributor to post-stroke disability, is a motor weakness on one (hemiparesis) side of the body. Presently, the only treatment available for patients with motor deficits is rehabilitative therapy. However, many patients are not responsive to standard rehabilitative therapy or achieve a less than satisfactory improvement in function.
The primary objective of this study is to determine the safety and effectiveness of targeted sub-threshold epidural cortical stimulation delivered concurrent with rehabilitation activities to enhance motor recovery in patients suffering from hemiparesis (a motor weakness in one half of the body) affecting the upper extremity (shoulder, arm, wrist, hand) following a stroke. In addition to evaluating changes from baseline level, safety and efficacy measures will be compared to patients who undergo the same rehabilitation activities but without cortical stimulation. The two study groups will be compared to determine the degree to which motor function of the affected limb can be improved beyond rehabilitation alone by epidural stimulation of a targeted cortical region.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Control
Rehabilitation
Rehabilitation is for 2.5 hrs per day for 26 days over a period of 6 weeks.
Investigational
Cortical Stimulation and rehabilitation
Cortical stimulation is provided concomitantly with rehabilitation therapy. Rehabilitation is for 2.5 hrs per day for 26 days over a period of 6 weeks.
Interventions
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Cortical Stimulation and rehabilitation
Cortical stimulation is provided concomitantly with rehabilitation therapy. Rehabilitation is for 2.5 hrs per day for 26 days over a period of 6 weeks.
Rehabilitation
Rehabilitation is for 2.5 hrs per day for 26 days over a period of 6 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Moderate to moderately severe upper-extremity hemiparesis.
* Aged 21 years or older.
Exclusion Criteria
* 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.
21 Years
ALL
No
Sponsors
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Northstar Neuroscience
INDUSTRY
Responsible Party
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Northstar Neuroscience
Locations
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University of Arizona Health Sciences Center
Tucson, Arizona, United States
University of Southern California
Los Angeles, California, United States
University of California San Francisco Medical Center
San Francisco, California, United States
Stanford University Medical Center
Stanford, California, United States
Colorado Neurological Institute & Swedish Medical Center
Englewood, Colorado, United States
University of Florida, Jacksonville
Jacksonville, Florida, United States
Emory Clinic
Atlanta, Georgia, United States
Northwestern University Medical Center and the Rehabilitation Institute of Chicago
Chicago, Illinois, United States
University of Illinois at Chicago
Chicago, Illinois, United States
Spaulding Rehabilitation Center and Massachusetts General Hospital
Boston, Massachusetts, United States
Wayne State University
Detroit, Michigan, United States
St. Luke's Hospital
Kansas City, Missouri, United States
Mount Sinai School of Medicine
New York, New York, United States
State University of New York Upstate Medical Center
Syracuse, New York, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Oregon Health Sciences University
Portland, Oregon, United States
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
University of Texas Health Sciences Center at Houston
Houston, Texas, United States
University of Utah Health Sciences Center
Salt Lake City, Utah, United States
Swedish Health Services
Seattle, Washington, United States
Countries
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References
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Brown JA, Lutsep H, Cramer SC, Weinand M. Motor cortex stimulation for enhancement of recovery after stroke: case report. Neurol Res. 2003 Dec;25(8):815-8. doi: 10.1179/016164103771953907.
Cramer SC, Benson RR, Himes DM, Burra VC, Janowsky JS, Weinand ME, Brown JA, Lutsep HL. Use of functional MRI to guide decisions in a clinical stroke trial. Stroke. 2005 May;36(5):e50-2. doi: 10.1161/01.STR.0000163109.67851.a0. Epub 2005 Apr 14.
Brown JA, Lutsep HL, Weinand M, Cramer SC. Motor cortex stimulation for the enhancement of recovery from stroke: a prospective, multicenter safety study. Neurosurgery. 2006 Mar;58(3):464-73. doi: 10.1227/01.NEU.0000197100.63931.04.
Levy RM, Harvey RL, Kissela BM, Winstein CJ, Lutsep HL, Parrish TB, Cramer SC, Venkatesan L. Epidural Electrical Stimulation for Stroke Rehabilitation: Results of the Prospective, Multicenter, Randomized, Single-Blinded Everest Trial. Neurorehabil Neural Repair. 2016 Feb;30(2):107-19. doi: 10.1177/1545968315575613. Epub 2015 Mar 6.
Related Links
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Other Identifiers
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V0267
Identifier Type: -
Identifier Source: org_study_id