RECRUITING

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

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Conditions

StrokeStroke, AcuteStroke, IschemicStroke Hemorrhagic

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-06-18
Study Completion:2027-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05338697

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 years or older
  2. * Unilateral stroke due to ischemia or intracerebral hemorrhage
  3. * 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).
  4. * Provision of signed and dated informed consent form within 48 to 96 hours of stroke onset (or time last known well).
  5. * Stated willingness to comply with all study procedures and availability for the duration of the study
  6. * Fluent in English or Spanish
  1. * UE injury or conditions on paretic side that limited use prior to the stroke.
  2. * Legally blind.
  3. * Dense sensory loss indicated by a score of 2 on NIHSS sensory item
  4. * Unable to abduct the shoulder or extend the fingers of the non-paretic arm/hand/wrist on verbal command
  5. * Isolated cerebellar stroke
  6. * Bilateral hemisphere acute strokes
  7. * 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
  8. * Known or expected inability to maintain follow-up with study procedures through 90 days
  9. * Cognitive or communication impairment precluding informed consent by the participant.
  10. * Major medical, neurological, or psychiatric condition that would substantially affect functional status
  11. * Non-cerebrovascular diagnosis associated with unlikely survival at 90 days
  12. * Pregnancy
  13. * Contraindication to noncontrast MRI (i.e., certain metallic implants, metallic foreign bodies or severe claustrophobia)
  14. * 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)
  15. * Unable to perform behavioral assessments within 48-120 hours of symptom onset
  16. * Unable to receive TMS or get MRI within 72-168 hours of symptom onset
  17. * Anticipated inability to perform study procedures within 168 hours of symptom onset.

Contacts and Locations

Study Contact

Pooja Khatri, MD
CONTACT
513-558-5478
pooja.khatri@uc.edu
Kalli Beasley, MPH
CONTACT
707-372-6241
Beasleki@ucmail.uc.edu

Principal Investigator

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 Locations (Sites)

University of Alabama
Birmingham, Alabama, 35233
United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
United States
San Francisco General Hospital
San Francisco, California, 94110
United States
UCSF Medical Center
San Francisco, California, 94143
United States
MedStar Washington Hospital Center
Washington, District of Columbia, 20010
United States
Emory University Hospital
Atlanta, Georgia, 30322
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
Montefiore Medical Center
Bronx, New York, 10467-0121
United States
NYU Langone Medical Center - Tisch Hospital
New York, New York, 10016
United States
Mount Sinai Hospital
New York, New York, 10029
United States
Strong Memorial Hospital
Rochester, New York, 14642
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
Harborview Medical Center
Seattle, Washington, 98104
United States
University of Wisconsin University Hospital
Madison, Wisconsin, 53792
United States
Froedtert & Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-18
Study Completion Date2027-01

Study Record Updates

Study Start Date2022-06-18
Study Completion Date2027-01

Terms related to this study

Additional Relevant MeSH Terms

  • Stroke
  • Stroke, Acute
  • Stroke, Ischemic
  • Stroke Hemorrhagic