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StrokeVERIFYNCT05338697

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

An observational study of Stroke and Stroke, Acute, run by Yale University at 45 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke, Stroke, Acute, Stroke, Ischemic
What is being tested?
Transcranial Magnetic Stimulation (TMS)
How many people
657 participants
Where
45 sitesUnited States
Study dates
18 Jun 2022to Oct 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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).
  • 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)

Who cannot join

  • 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.
Show all 24Show fewer
  • 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)
  • 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)
  • Ferromagnetic intracranial metallic implant
  • 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
  • Anticipated inability to perform study procedures within 168 hours of symptom onset
  • Unable to perform behavioral assessments within 48-120 hours of symptom onset (or time last known well).
  • Unable to receive TMS within 72-168 hours or get MRI within 48-168 hours of symptom onset (or time last known well).

Trial locations and contacts

45 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Pooja Khatri, MD contact

203-747-4730

pooja.khatri@yale.edu

Kalli Beasley, MPH contact

707-372-6241

Beasleki@ucmail.uc.edu

45 sites in 1 country

United States45 sites, 40 recruiting

  • University of Michigan

    Ann Arbor, Michigan, 48108

    Chandramouli Krishnan, PT, PhD, mouli@umich.edu

    Chandramouli Krishnan, PT, PhD

    Recruiting

  • Emory University Hospital

    Atlanta, Georgia, 30322

    Michael Borich, PT, PhD, 404-640-3150, michael.borich@emory.edu

    Michael Borich, PT, PhD

    Recruiting

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

    Active, not recruiting

  • Birmingham VA Medical Center

    Birmingham, Alabama, 35233

    Michael Lyerly, MD, mlyerly@uabmc.edu

    Michael Lyerly, MD

    Recruiting

  • University of Alabama

    Birmingham, Alabama, 35233

    Toby Gropen, MD, tgropen@uabmc.edu

    Toby Gropen, MD

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    David J Lin, MD

    David J Lin, MD

    Recruiting

  • NYU Langone Hospital - Brooklyn

    Brooklyn, New York, 11220

    Suspended

  • Lahey Hospital & Medical Center

    Burlington, Massachusetts, 01805

    Siddharth Sehgal, MD, siddharth.sehgal@lahey.org

    Siddharth Sehgal

    Recruiting

  • Memorial Hospital of Carbondale

    Carbondale, Illinois, 62901

    Andrea Loggini, MD, andrea.loggini@sih.net

    Andrea Loggini, MD

    Recruiting

  • Medical University of South Carolina (MUSC)

    Charleston, South Carolina, 29425

    Kirstin Heise, PhD, 843-792-3435, heisek@musc.edu

    Kirstin Heise, PhD

    Recruiting

  • UVA Medical Center

    Charlottesville, Virginia, 22903

    Chad Aldridge, PT, PhD, CMA7N@hscmail.mcc.virginia.edu

    Chad Aldridge, PT, PhD

    Recruiting

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219

    Oluwole Awosika, MD, 513-558-5328, awosikoe@ucmail.uc.edu

    Oluwole Awosika, MD

    Recruiting

  • Prisma Health Richland Hospital

    Columbia, South Carolina, 29203

    Forrest Lowe, MD, forrest.lowe@prismahealth.org

    Forrest Lowe, MD

    Recruiting

  • OSU Wexner Medical Center

    Columbus, Ohio, 43210

    Yousef Hannawi, MD, 614-685-7234, Yousef.hannawi@osumc.edu

    Yousef Hannawi, MD

    Recruiting

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

    Benjamin Nguyen, MD, 214-633-4794, Benjamin.Nguyen@UTSouthwestern.edu

    Benjamin Nguyen, MD

    Recruiting

  • Duke University Hospital

    Durham, North Carolina, 27710

    Wayne Feng, MD, 919-684-3801, wayne.feng@duke.edu

    Wayne Feng, MD

    Recruiting

  • Corewell Heath Butterworth Hospital

    Grand Rapids, Michigan, 49503

    Malgorzata M Miller, MD, 'Malgorzata.miller@corewellhealth.org

    M

    Recruiting

  • Penn State Hershey Medical Center

    Hershey, Pennsylvania, 17033

    Raymond Reichwein, MD, 717-461-1220, rreichwein@psu.edu

    Raymond Reichwein, MD

    Recruiting

  • Houston Methodist Hospital

    Houston, Texas, 77030

    Withdrawn

  • Memorial Hermann Texas Medical Center

    Houston, Texas, 77030

    Sean Savitz, MD, 617-233-1988, Sean.I.Savitz@uth.tmc.edu

    Sean Savitz, MD

    Recruiting

  • IU Health Methodist Hospital

    Indianapolis, Indiana, 46202

    Ann Jones, MD, annjone@iu.edu

    Ann Jones, MD

    Recruiting

  • University of Iowa Hospitals & Clinics

    Iowa City, Iowa, 52242

    Hannah Roeder, MD, MPH, 319-356-8755, hannah-roeder@uiowa.edu

    Hannah Roeder, MD

    Recruiting

  • Keck Medical Center of USC

    Los Angeles, California, 90033

    Sook-Lei Liew, PhD, OTR/L, sliew@usc.edu

    Sook-Lei Liew, PhD, OTR/L

    Recruiting

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California, 90095

    Withdrawn

  • University of Wisconsin University Hospital

    Madison, Wisconsin, 53792

    Azam S. Ahmed, MD, 608-201-0957, azam.ahmed@neurosurgery.wisc.edu

    Azam S. Ahmed, MD

    Recruiting

  • Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

    Thomas Wolfe, MD, Thomas.Wolfe@aah.org

    Thomas Wolfe, MD

    Recruiting

  • Froedtert & Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Caitlin Moore, MD, camoore@mcw.edu

    Caitlin Moore, MD

    Recruiting

  • Yale New Haven Hospital

    New Haven, Connecticut, 06511

    Rebecca DiBiase, MD, rebecca.dibiase@yale.edu

    Recruiting

  • The Mount Sinai Hospital

    New York, New York, 10029

    Neha Dangayach, MD, neha.dangayach@mountsinai.org

    Neha Dangayach, MD

    Recruiting

  • Advocate Lutheran General Hospital

    Park Ridge, Illinois, 60068

    Anit Behera, MD, anit.behera@aah.org

    Recruiting

  • Pennsylvania Hospital

    Philadelphia, Pennsylvania, 19107

    Kelly Sloan, MD, Kelly.Sloane@Pennmedicine.upenn.edu

    Kelly Sloan, MD

    Recruiting

  • UPMC Presbyterian Hospital

    Pittsburgh, Pennsylvania, 15213

    George Wittenberg, MD, PhD, 412- 648-4178, geowitt@pitt.edu

    George Wittenberg, MD, PhD

    Recruiting

  • Kaiser Permanente Redwood City Medical Center

    Redwood City, California, 94063

    Sheila Chan, MD, Sheila.Chan@kp.org

    Sheila Chan, MD

    Recruiting

  • Richmond VA Medical Center

    Richmond, Virginia, 23249

    Withdrawn

  • Mayo Clinic Saint Marys Campus

    Rochester, Minnesota, 55902

    Muhib Khan, MBBS, MD, RPNI, Khan.Muhib@mayo.edu

    Muhib Khan, MBBS, MD, RPNI

    Recruiting

  • Strong Memorial Hospital

    Rochester, New York, 14642

    Ania Busza, MD, PhD, Ania_Busza@URMC.Rochester.edu

    Ania Busza, MD, PhD

    Recruiting

  • University of Utah Healthcare

    Salt Lake City, Utah, 84132

    Lorie Richards, PhD, 352-317-1023, lorie.richards@hsc.utah.edu

    Lorie Richards, PhD

    Recruiting

  • San Francisco General Hospital

    San Francisco, California, 94110

    Cathra Halabi, MD, Cathra.halabi@ucsf.edu

    Cathra Halabi, MD

    Recruiting

  • UCSF Medical Center

    San Francisco, California, 94143

    Cathra Halabi, MD, Cathra.halabi@ucsf.edu

    Cathra Halabi, MD

    Recruiting

  • Harborview Medical Center

    Seattle, Washington, 98104

    Nicole Mazwi, MD, nmazwi@uw.edu

    David Tirschwell, MD, MSc

    Recruiting

  • Baystate Medical Center

    Springfield, Massachusetts, 01199

    Gottfried Schlaug, MD, PhD, 617-319-5953, gottfried.schlaug@bhs.org

    Gottfried Schlaug, MD, PhD

    Recruiting

  • Montefiore Medical Center

    The Bronx, New York, 10467-0121

    Cynthia Hung, MD, cyhung@montefiore.org

    Cynthia Hung, MD

    Recruiting

  • Banner University Medical Center

    Tucson, Arizona, 85719

    Firas Kaddouh, MD, MHS, firaskaddouh@arizona.edu

    Recruiting

  • Westchester Medical Center

    Valhalla, New York, 10595

    Tomoko Kitago, MD, tomoko.kitago@wmchealth.org

    Tomoko Kitago, MD

    Recruiting

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

    Matt Edwardson, MD, 202-687-2184, mae97@georgetown.edu

    Matt Edwardson, MD

    Recruiting

Other trials in United States

About this study

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.

Read the 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.

Being tested
Transcranial Magnetic Stimulation (TMS)
Keywords
VERIFY
Medical subject headings
Stroke, Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT05338697
Study groupRoleWhat they receive
Ischemic & Hemorrhagic stroke patientsup to 657 stroke patients
Receives: Diagnostic Test: Transcranial Magnetic Stimulation (TMS)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 90 days post-stroke

  2. Action Research Arm Test (ARAT) for AIM 2

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

    Measured: 90 days post-stroke

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2022
  2. Study start18 Jun 2022
  3. Primary completionJan 2027 (estimated)
  4. Study completionOct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
657 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05338697
Sponsor's protocol ID
2000040598
Other IDs
7U01NS120910-05, G200291, Pro00054139
Acronym
VERIFY
Status last verified
Aug 2026
First submitted
13 Apr 2022
Last updated
20 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke and Stroke, Acute, run by Yale University at 45 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Pooja Khatri, MD (203-747-4730, pooja.khatri@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Upper Extremity-Fugl Meyer (UE-FM) for AIM 1 (time frame: 90 days post-stroke). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05338697.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.

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