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

Description

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, Stroke Hemorrhagic

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

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

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

Condition
Stroke
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama, Birmingham, Alabama, United States, 35233

Los Angeles

Ronald Reagan UCLA Medical Center, Los Angeles, California, United States, 90095

San Francisco

San Francisco General Hospital, San Francisco, California, United States, 94110

San Francisco

UCSF Medical Center, San Francisco, California, United States, 94143

Washington

MedStar Washington Hospital Center, Washington, District of Columbia, United States, 20010

Atlanta

Emory University Hospital, Atlanta, Georgia, United States, 30322

Iowa City

University of Iowa Hospitals & Clinics, Iowa City, Iowa, United States, 52242

Baltimore

University of Maryland Medical Center, Baltimore, Maryland, United States, 21201

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Burlington

Lahey Hospital & Medical Center, Burlington, Massachusetts, United States, 01805

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Age 18 years or older
  • * Unilateral stroke due to ischemia or intracerebral hemorrhage
  • * Motor deficits in the acutely affected UE, defined as a Shoulder Abduction and Finger Extension (SAFE) score ≤ 8 out of 10 points (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).
  • * Provision of signed and dated informed consent form within 48 to 96 hours of stroke onset (or time last known well).
  • * Stated willingness to comply with all study procedures and availability for the duration of the study
  • * Fluent in English or Spanish
  • * UE injury or conditions on paretic side that limited use prior to the stroke.
  • * Legally blind.
  • * Dense sensory loss indicated by a score of 2 on NIHSS sensory item
  • * Unable to abduct the shoulder or extend the fingers of the non-paretic arm/hand/wrist on verbal command
  • * Isolated cerebellar stroke
  • * Bilateral hemisphere acute strokes
  • * 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 (i.e., certain metallic implants, metallic foreign bodies or severe claustrophobia)
  • * Contraindication to TMS (i.e., cardiac pacemaker or other electronic devices in the body at or above the level of the seventh cervical vertebra, such as cochlear implant, cortical stimulator, deep brain stimulator, vagus nerve stimulator, cervical spine epidural stimulator, or ventriculoperitoneal shunt; Skull defect related to current stroke; Seizure after onset of current stroke; Seizure within the last 12 months while taking anti-epileptic medications; Previous serious adverse reaction to TMS)
  • * Unable to perform behavioral assessments within 48-120 hours of symptom onset
  • * Unable to receive TMS or get MRI within 72-168 hours of symptom onset
  • * Anticipated inability to perform study procedures within 168 hours of symptom onset.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University of Cincinnati,

Pooja Khatri, MD, PRINCIPAL_INVESTIGATOR, University of Cincinnati

Steve Cramer, MD, PRINCIPAL_INVESTIGATOR, University of California, Los Angeles

Cathy Stinear, PhD, PRINCIPAL_INVESTIGATOR, University of Auckland, New Zealand

Achala Vagal, MD, PRINCIPAL_INVESTIGATOR, University of Cincinnati

Study Record Dates

2027-01