Stroke Clinical Trial
— EVERESTOfficial title:
Safety and Effectiveness of Targeted Sub-Threshold Epidural Cortical Stimulation Delivered Concurrent With Rehabilitation Activities to Enhance Motor Recovery in Patients Suffering From Upper Extremity Hemiparesis Following a Stroke
Verified date | December 2007 |
Source | Northstar Neuroscience |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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 hemiparesis affecting the upper extremity following a stroke.
Status | Active, not recruiting |
Enrollment | 174 |
Est. completion date | March 2008 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years and older |
Eligibility |
Inclusion Criteria: - Subjects must have an ischemic stroke. - Moderate to moderately severe upper-extremity hemiparesis. - Aged 21 years or older. Exclusion Criteria: - 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Emory Clinic | Atlanta | Georgia |
United States | Spaulding Rehabilitation Center and Massachusetts General Hospital | Boston | Massachusetts |
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 | University of Cincinnati Medical Center | Cincinnati | Ohio |
United States | Wayne State University | Detroit | Michigan |
United States | Colorado Neurological Institute & Swedish Medical Center | Englewood | Colorado |
United States | University of Texas Health Sciences Center at Houston | Houston | Texas |
United States | University of Florida, Jacksonville | Jacksonville | Florida |
United States | St. Luke's Hospital | Kansas City | Missouri |
United States | University of Southern California | Los Angeles | California |
United States | Mount Sinai School of Medicine | New York | New York |
United States | University of Pennsylvania Medical Center | Philadelphia | Pennsylvania |
United States | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
United States | Oregon Health Sciences University | Portland | Oregon |
United States | University of Utah Health Sciences Center | Salt Lake City | Utah |
United States | University of California San Francisco Medical Center | San Francisco | California |
United States | Swedish Health Services | Seattle | Washington |
United States | Stanford University Medical Center | Stanford | California |
United States | State University of New York Upstate Medical Center | Syracuse | New York |
United States | University of Arizona Health Sciences Center | Tucson | Arizona |
Lead Sponsor | Collaborator |
---|---|
Northstar Neuroscience |
United States,
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. — View Citation
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. — View Citation
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. Epub 2005 Apr 14. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Arm Motor Fugl-Meyer (AMFM) score | Follow Up Week 4 | No | |
Primary | Arm Motor Ability Test (AMAT) score | Follow Up Week 4 | No | |
Secondary | Box and Block Test score | Follow Up Week 4 | No | |
Secondary | Stroke Specific Quality of Life (SSQOL) score | Follow Up Week 4 | No | |
Secondary | Serious adverse event rate | Follow up week 4 and 6 months | Yes |
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