Validation of Early Prognostic Data for Recovery Outcome After Stroke for Future, Higher Yield Trials
NCT ID: NCT05338697
Last Updated: 2025-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
657 participants
OBSERVATIONAL
2022-06-18
2027-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Ischemic & Hemorrhagic stroke patients
up to 657 stroke patients
Transcranial Magnetic Stimulation (TMS)
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.
Interventions
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Transcranial Magnetic Stimulation (TMS)
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.
Eligibility Criteria
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Inclusion Criteria
2. Unilateral symptomatic stroke due to ischemia. (Note: Bilateral acute stroke is permitted if the stroke that is contralateral to the index stroke is asymptomatic).
3. 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.
4. 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)
5. 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.
6. Fluent in study approved languages (i.e., English or Spanish)
Exclusion Criteria
2. Legally blind
3. Dense sensory loss on paretic side indicated by a score of 2 on NIHSS sensory item
4. Unable to abduct the shoulder or extend the fingers of the non-paretic UE on verbal command
5. Isolated cerebellar stroke
6. Symptomatic stroke in any location within 30 days prior to index stroke.
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 (certain metallic implants, metallic foreign bodies or severe claustrophobia)
14. Contraindication to TMS
1. Implanted electronic cardiac devices (e.g., Automatic Implantable Cardioverter-Defibrillator \[AICD\] or pacemaker)
2. Any 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)
3. Ferromagnetic intracranial metallic implant
4. Skull defect related to current stroke
5. Seizure after onset of current stroke
6. Seizure within the last 12 months while taking anti-epileptic medications
7. Previous serious adverse reaction to TMS
15. Anticipated inability to perform study procedures within 168 hours of symptom onset
1. Unable to perform behavioral assessments within 48-120 hours of symptom onset (or time last known well).
2. Unable to receive TMS within 72-168 hours or get MRI within 48-168 hours of symptom onset (or time last known well).
18 Years
ALL
No
Sponsors
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University of California, Los Angeles
OTHER
University of Auckland, New Zealand
OTHER
Medical University of South Carolina
OTHER
University of Cincinnati
OTHER
Responsible Party
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Pooja Khatri
Professor & Chair of Neurology
Principal Investigators
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Pooja Khatri, MD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Steve Cramer, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Cathy Stinear, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Auckland, New Zealand
Achala Vagal, MD
Role: PRINCIPAL_INVESTIGATOR
University of Cincinnati
Locations
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Birmingham VA Medical Center
Birmingham, Alabama, United States
University of Alabama
Birmingham, Alabama, United States
Banner University Medical Center
Tucson, Arizona, United States
Keck Medical Center of USC
Los Angeles, California, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
Kaiser Permanente Redwood City Medical Center
Redwood City, California, United States
San Francisco General Hospital
San Francisco, California, United States
UCSF Medical Center
San Francisco, California, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Emory University Hospital
Atlanta, Georgia, United States
Memorial Hospital of Carbondale
Carbondale, Illinois, United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, United States
IU Health Methodist Hospital
Indianapolis, Indiana, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Lahey Hospital & Medical Center
Burlington, Massachusetts, United States
Baystate Medical Center
Springfield, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Corewell Heath Butterworth Hospital
Grand Rapids, Michigan, United States
Mayo Clinic Saint Marys Campus
Rochester, Minnesota, United States
NYU Langone Hospital - Brooklyn
Brooklyn, New York, United States
The Mount Sinai Hospital
New York, New York, United States
Strong Memorial Hospital
Rochester, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Westchester Medical Center
Valhalla, New York, United States
Duke University Hospital
Durham, North Carolina, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
OSU Wexner Medical Center
Columbus, Ohio, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States
Prisma Health Richland Hospital
Columbia, South Carolina, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
Memorial Hermann Texas Medical Center
Houston, Texas, United States
University of Utah Healthcare
Salt Lake City, Utah, United States
UVA Medical Center
Charlottesville, Virginia, United States
Richmond VA Medical Center
Richmond, Virginia, United States
Harborview Medical Center
Seattle, Washington, United States
University of Wisconsin University Hospital
Madison, Wisconsin, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Froedtert & Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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David J Lin, MD
Role: primary
M
Role: backup
Related Links
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Information about the study.
Other Identifiers
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G200291
Identifier Type: -
Identifier Source: org_study_id
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