Validation of Early Prognostic Data for Recovery Outcome After Stroke for Future, Higher Yield Trials
Start Date
6/18/2022
Completion Date
10/1/2027
Summary
VERIFY will validate biomarkers of upper extremity (UE) motor outcome in the acute ischemic stroke window for immediate use in clinical trials, and explore these biomarkers in acute intracerebral hemorrhage. VERIFY will create the first multicenter, large-scale, prospective dataset of clinical, transmagnetic stimulation (TMS), and MRI measures in the acute stroke time window.
Detailed Description
Currently, 7 million US stroke survivors have significant disability, more than half with residual motor deficits. Motor function, particularly of the upper extremity (UE), is critical for regaining independence after stroke. UE function largely depends on integrity of motor cortex and its descending fibers, collectively termed the corticomotor system (CMS). Validated, clinically relevant biomarkers that identify biologically distinct patient subgroups are critically needed, particularly for the often affected and functionally important CMS. Their absence is a major obstacle to developing and personalizing new recovery therapies, especially in the early days post stroke. Presence or absence of motor evoked potential (MEP) responses to TMS and extent of MRI-measured acute lesion load involving corticospinal tract (CST) are ready for formal validation. Also, the Predict Recovery Potential (PREP)-2 prediction tool, which sequentially combines acute clinical information and MEP status, is primed for multi-site validation. The central objective is to validate the most biologically relevant and primed biomarkers of 90-day UE motor outcomes after ischemic stroke in the first large-scale, prospective, acute dataset of clinical, TMS, and MRI measures. The central hypothesis is that patients have different UE outcomes depending on CMS function measured with TMS, and on CST injury measured with MRI. The specific aims are: 1. to externally validate the relationships that TMS and MRI biomarkers of CMS integrity have with 90-day UE motor impairment outcome and 2. to externally validate the PREP2 prediction tool to predict 90- day UE functional outcome. The study will also explore these biomarkers in acute intracerebral hemorrhage. The study will comprehensively measure UE outcomes 90 days post-stroke in three domains of motor performance -impairment, function, and use - identified by the World Health Organization International Classification of Functioning, Disability and Health. By establishing biomarkers for use in the acute stroke period to identify patient subgroups with distinct 90-day outcomes, the study will improve the efficiency of stroke recovery trials and inform rehabilitation decision-making. Sample Size: up to 657 participants with complete biomarker data enrolled at up to 45 sites. Trial Status: VERIFY received formal FDA IDE approval in November 2020 and received NIH funding in September 2021. Participating sites from the United States have been identified, and the study is now enrolling eligible participants.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Transcranial Magnetic Stimulation (TMS)
Conditions
Locations
Birmingham VA Medical Center
Birmingham, Alabama 35233
United States
University of Alabama
Birmingham, Alabama 35233
United States
Banner University Medical Center
Tucson, Arizona 85719
United States
Keck Medical Center of USC
Los Angeles, California 90033
United States
Ronald Reagan UCLA Medical Center
Los Angeles, California 90095
United States
Kaiser Permanente Redwood City Medical Center
Redwood City, California 94063
United States
San Francisco General Hospital
San Francisco, California 94110
United States
UCSF Medical Center
San Francisco, California 94143
United States
Yale New Haven Hospital
New Haven, Connecticut 06511
United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia 20010
United States
Emory University Hospital
Atlanta, Georgia 30322
United States
Memorial Hospital of Carbondale
Carbondale, Illinois 62901
United States
Advocate Lutheran General Hospital
Park Ridge, Illinois 60068
United States
IU Health Methodist Hospital
Indianapolis, Indiana 46202
United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa 52242
United States
University of Maryland Medical Center
Baltimore, Maryland 21201
United States
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Lahey Hospital & Medical Center
Burlington, Massachusetts 01805
United States
Baystate Medical Center
Springfield, Massachusetts 01199
United States
University of Michigan
Ann Arbor, Michigan 48108
United States
Corewell Heath Butterworth Hospital
Grand Rapids, Michigan 49503
United States
Mayo Clinic Saint Marys Campus
Rochester, Minnesota 55902
United States
NYU Langone Hospital - Brooklyn
Brooklyn, New York 11220
United States
The Mount Sinai Hospital
New York, New York 10029
United States
Strong Memorial Hospital
Rochester, New York 14642
United States
Montefiore Medical Center
The Bronx, New York 10467-0121
United States
Westchester Medical Center
Valhalla, New York 10595
United States
Duke University Hospital
Durham, North Carolina 27710
United States
University of Cincinnati Medical Center
Cincinnati, Ohio 45219
United States
OSU Wexner Medical Center
Columbus, Ohio 43210
United States
Penn State Hershey Medical Center
Hershey, Pennsylvania 17033
United States
Pennsylvania Hospital
Philadelphia, Pennsylvania 19107
United States
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania 15213
United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina 29425
United States
Prisma Health Richland Hospital
Columbia, South Carolina 29203
United States
UT Southwestern Medical Center
Dallas, Texas 75390
United States
Houston Methodist Hospital
Houston, Texas 77030
United States
Memorial Hermann Texas Medical Center
Houston, Texas 77030
United States
University of Utah Healthcare
Salt Lake City, Utah 84132
United States
UVA Medical Center
Charlottesville, Virginia 22903
United States
Richmond VA Medical Center
Richmond, Virginia 23249
United States
Harborview Medical Center
Seattle, Washington 98104
United States
University of Wisconsin University Hospital
Madison, Wisconsin 53792
United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin 53215
United States
Froedtert & Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United States