Safety and Effectiveness of Cortical Stimulation in the Treatment of Stroke Patients With Upper Extremity Hemiparesis
EVEREST
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
1 other identifier
interventional
174
1 country
21
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 hemiparesis affecting the upper extremity following a stroke.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 stroke
Started Sep 2004
Typical duration for phase_3 stroke
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedDecember 28, 2007
December 1, 2007
September 9, 2005
December 18, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Arm Motor Fugl-Meyer (AMFM) score
Follow Up Week 4
Arm Motor Ability Test (AMAT) score
Follow Up Week 4
Secondary Outcomes (3)
Box and Block Test score
Follow Up Week 4
Stroke Specific Quality of Life (SSQOL) score
Follow Up Week 4
Serious adverse event rate
Follow up week 4 and 6 months
Study Arms (2)
Control
ACTIVE COMPARATORInvestigational
EXPERIMENTALInterventions
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 is for 2.5 hrs per day for 26 days over a period of 6 weeks.
Eligibility Criteria
You may qualify if:
- Subjects must have an ischemic stroke.
- Moderate to moderately severe upper-extremity hemiparesis.
- Aged 21 years or older.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
University of Arizona Health Sciences Center
Tucson, Arizona, 85724, United States
University of Southern California
Los Angeles, California, 90089, United States
University of California San Francisco Medical Center
San Francisco, California, 94125, United States
Stanford University Medical Center
Stanford, California, 94305, United States
Colorado Neurological Institute & Swedish Medical Center
Englewood, Colorado, 80113, United States
University of Florida, Jacksonville
Jacksonville, Florida, 32209-6511, United States
Emory Clinic
Atlanta, Georgia, 30322, United States
Northwestern University Medical Center and the Rehabilitation Institute of Chicago
Chicago, Illinois, 60611, United States
University of Illinois at Chicago
Chicago, Illinois, 60612, United States
Spaulding Rehabilitation Center and Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Wayne State University
Detroit, Michigan, 48201, United States
St. Luke's Hospital
Kansas City, Missouri, 64111, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
State University of New York Upstate Medical Center
Syracuse, New York, 13210, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267, United States
Oregon Health Sciences University
Portland, Oregon, 97201, United States
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
University of Texas Health Sciences Center at Houston
Houston, Texas, 77030, United States
University of Utah Health Sciences Center
Salt Lake City, Utah, 84132, United States
Swedish Health Services
Seattle, Washington, 98122, United States
Related Publications (4)
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.
PMID: 14669524BACKGROUNDCramer 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.
PMID: 15831835BACKGROUNDBrown 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.
PMID: 16528186BACKGROUNDLevy 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.
PMID: 25748452DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 15, 2005
Study Start
September 1, 2004
Study Completion
March 1, 2008
Last Updated
December 28, 2007
Record last verified: 2007-12