Validation of Early Prognostic Data for Recovery Outcome After Stroke for Future, Higher Yield Trials

NCT05338697 | Recruiting FDA Device

• 1 other identifier: G200291
• Study Type: observational
• Target: 657
• Locations: 1 country
• Sites: 45

Brief 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.

Conditions

Stroke; Stroke, Acute; Stroke, Ischemic

Keywords

VERIFY

Outcome Measures

Primary Outcomes (2)

• Upper Extremity-Fugl Meyer (UE-FM) for AIM 1

  UE-FM score, as a continuous scale, adjusted for baseline score in analysis

  90 days post-stroke

• Action Research Arm Test (ARAT) for AIM 2

  ARAT categorized as 'excellent', 'good', 'limited', or 'poor'

  90 days post-stroke

Other Outcomes (2)

• Motor Activity Log (MAL)

  90 days post-stroke

• modified Rankin Score (mRS)

  90 days post-stroke

Study Arms (1)

Ischemic & Hemorrhagic stroke patients

up to 657 stroke patients

Diagnostic Test: Transcranial Magnetic Stimulation (TMS)

Interventions

Transcranial Magnetic Stimulation (TMS) DIAGNOSTIC_TEST

No intervention used. This study is using TMS to obtain motor evoked potential (MEP), a prognostic biomarker. The TMS procedure is being conducted during the first week of hospitalization, which required registration under an IDE. Only TMS devices that have received 510(k) clearance from the FDA are used in this study, consisting of MEGA-TMS and MagStim 200-2.

Ischemic & Hemorrhagic stroke patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with ischemic stroke consented within 24-96 hours of stroke onset in the acute hospitalization setting

You may qualify if:

• Age 18 years or older
• Unilateral symptomatic stroke due to ischemia. (Note: Bilateral acute stroke is permitted if the stroke that is contralateral to the index stroke is asymptomatic).
• Motor deficits in the acutely affected UE, defined as a Shoulder Abduction and Finger Extension (SAFE) score ≤ 8 out of 10 points20,61 (i.e., excluding full or nearly full motor strength in both shoulder abduction and finger extension) within 48 to 96 hours of stroke onset (or time last known well).
• a. Please note that, if significant imbalance is observed in SAFE score or MEP+ rates, the enrollment threshold for SAFE score may be updated with a formal study memo.
• Provision of signed and dated informed consent form within 24 to 96 hours of stroke onset, (or time last known well). Note: Participant is considered "enrolled" upon starting TMS (at least one stimulation is delivered) or starting study-specific MRI pulse sequence (at least one MRI beep occurs)
• Stated willingness to comply with all study procedures and availability for the duration of the study, including Day 90 visit which must occur in-person.
• Fluent in study approved languages (i.e., English or Spanish)

You may not qualify if:

• UE injury or conditions on paretic side that limited use prior to the stroke
• Legally blind
• Dense sensory loss on paretic side indicated by a score of 2 on NIHSS sensory item
• Unable to abduct the shoulder or extend the fingers of the non-paretic UE on verbal command
• Isolated cerebellar stroke
• Symptomatic stroke in any location within 30 days prior to index stroke.
• Co-enrollment in a trial of an intervention targeting the incident stroke (acute treatment or rehabilitation/recovery intervention) after baseline assessments for VERIFY are initiated
• Known or expected inability to maintain follow-up with study procedures through 90 days
• Cognitive or communication impairment precluding informed consent by the participant.
• Major medical, neurological, or psychiatric condition that would substantially affect functional status
• Non-cerebrovascular diagnosis associated with unlikely survival at 90 days
• Pregnancy
• Contraindication to noncontrast MRI (certain metallic implants, metallic foreign bodies or severe claustrophobia)
• Contraindication to TMS
• Implanted electronic cardiac devices (e.g., Automatic Implantable Cardioverter-Defibrillator \[AICD\] or pacemaker)

Sponsors & Collaborators

• University of Cincinnati: lead
• University of California, Los Angeles: collaborator
• University of Auckland, New Zealand: collaborator
• Medical University of South Carolina: collaborator

Study Sites (45)

Birmingham VA Medical Center

Birmingham, Alabama, 35233, United States

RECRUITING

University of Alabama

Birmingham, Alabama, 35233, United States

RECRUITING

Banner University Medical Center

Tucson, Arizona, 85719, United States

NOT YET RECRUITING

Keck Medical Center of USC

Los Angeles, California, 90033, United States

RECRUITING

Ronald Reagan UCLA Medical Center

Los Angeles, California, 90095, United States

WITHDRAWN

Kaiser Permanente Redwood City Medical Center

Redwood City, California, 94063, United States

NOT YET RECRUITING

San Francisco General Hospital

San Francisco, California, 94110, United States

RECRUITING

UCSF Medical Center

San Francisco, California, 94143, United States

RECRUITING

Yale New Haven Hospital

New Haven, Connecticut, 06511, United States

NOT YET RECRUITING

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

RECRUITING

Emory University Hospital

Atlanta, Georgia, 30322, United States

RECRUITING

Memorial Hospital of Carbondale

Carbondale, Illinois, 62901, United States

NOT YET RECRUITING

Advocate Lutheran General Hospital

Park Ridge, Illinois, 60068, United States

NOT YET RECRUITING

IU Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

NOT YET RECRUITING

University of Iowa Hospitals & Clinics

Iowa City, Iowa, 52242, United States

RECRUITING

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

ACTIVE NOT RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Lahey Hospital & Medical Center

Burlington, Massachusetts, 01805, United States

RECRUITING

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48108, United States

RECRUITING

Corewell Heath Butterworth Hospital

Grand Rapids, Michigan, 49503, United States

RECRUITING

Mayo Clinic Saint Marys Campus

Rochester, Minnesota, 55902, United States

NOT YET RECRUITING

NYU Langone Hospital - Brooklyn

Brooklyn, New York, 11220, United States

SUSPENDED

The Mount Sinai Hospital

New York, New York, 10029, United States

RECRUITING

Strong Memorial Hospital

Rochester, New York, 14642, United States

RECRUITING

Montefiore Medical Center

The Bronx, New York, 10467-0121, United States

RECRUITING

Westchester Medical Center

Valhalla, New York, 10595, United States

RECRUITING

Duke University Hospital

Durham, North Carolina, 27710, United States

RECRUITING

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

RECRUITING

OSU Wexner Medical Center

Columbus, Ohio, 43210, United States

RECRUITING

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

RECRUITING

Pennsylvania Hospital

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Medical University of South Carolina (MUSC)

Charleston, South Carolina, 29425, United States

RECRUITING

Prisma Health Richland Hospital

Columbia, South Carolina, 29203, United States

RECRUITING

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

Houston Methodist Hospital

Houston, Texas, 77030, United States

WITHDRAWN

Memorial Hermann Texas Medical Center

Houston, Texas, 77030, United States

RECRUITING

University of Utah Healthcare

Salt Lake City, Utah, 84132, United States

RECRUITING

UVA Medical Center

Charlottesville, Virginia, 22903, United States

RECRUITING

Richmond VA Medical Center

Richmond, Virginia, 23249, United States

NOT YET RECRUITING

Harborview Medical Center

Seattle, Washington, 98104, United States

RECRUITING

University of Wisconsin University Hospital

Madison, Wisconsin, 53792, United States

RECRUITING

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

NOT YET RECRUITING

Froedtert & Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Related Links

• Information about the study.

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Pooja Khatri, MD

  Yale University

  PRINCIPAL INVESTIGATOR

• Steve Cramer, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Cathy Stinear, PhD

  University of Auckland, New Zealand

  PRINCIPAL INVESTIGATOR

• Achala Vagal, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pooja Khatri, MD

CONTACT

203-747-4730; pooja.khatri@yale.edu

Kalli Beasley, MPH

CONTACT

707-372-6241; Beasleki@ucmail.uc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor & Chair of Neurology

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: April 21, 2022
• Study Start: June 18, 2022
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: October 15, 2025

Record last verified: 2025-10

Locations

US (45)