What this study is
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.
What's being tested
- Transcranial Magnetic Stimulation (TMS)
Intervention · 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 details
- Sponsor
- Yale University
- Conditions
- Stroke · Stroke, Acute · Stroke, Ischemic
- Enrolling
- 657 people
- Starts
- 2022-06-18
- Est. completion
- 2027-10
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou 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 can't join 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); 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).
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (45)
40 openBirmingham VA Medical Center
Birmingham, Alabama, United States
- Michael Lyerly, MD · Contactmlyerly@uabmc.edu
- Michael Lyerly, MD · Principal investigator
RecruitingUniversity of Alabama
Birmingham, Alabama, United States
- Toby Gropen, MD · Contacttgropen@uabmc.edu
- Toby Gropen, MD · Principal investigator
RecruitingBanner University Medical Center
Tucson, Arizona, United States
- Firas Kaddouh, MD, MHS · Contactfiraskaddouh@arizona.edu
RecruitingKeck Medical Center of USC
Los Angeles, California, United States
- Sook-Lei Liew, PhD, OTR/L · Contactsliew@usc.edu
- Sook-Lei Liew, PhD, OTR/L · Principal investigator
RecruitingKaiser Permanente Redwood City Medical Center
Redwood City, California, United States
- Sheila Chan, MD · ContactSheila.Chan@kp.org
- Sheila Chan, MD · Principal investigator
RecruitingSan Francisco General Hospital
San Francisco, California, United States
- Cathra Halabi, MD · ContactCathra.halabi@ucsf.edu
- Cathra Halabi, MD · Principal investigator
RecruitingUCSF Medical Center
San Francisco, California, United States
- Cathra Halabi, MD · ContactCathra.halabi@ucsf.edu
- Cathra Halabi, MD · Principal investigator
RecruitingYale New Haven Hospital
New Haven, Connecticut, United States
- Rebecca DiBiase, MD · Contactrebecca.dibiase@yale.edu
RecruitingMedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
- Matt Edwardson, MD · Contact202-687-2184mae97@georgetown.edu
- Matt Edwardson, MD · Principal investigator
RecruitingEmory University Hospital
Atlanta, Georgia, United States
- Michael Borich, PT, PhD · Contact404-640-3150michael.borich@emory.edu
- Michael Borich, PT, PhD · Principal investigator
RecruitingMemorial Hospital of Carbondale
Carbondale, Illinois, United States
- Andrea Loggini, MD · Contactandrea.loggini@sih.net
- Andrea Loggini, MD · Principal investigator
RecruitingAdvocate Lutheran General Hospital
Park Ridge, Illinois, United States
- Anit Behera, MD · Contactanit.behera@aah.org
RecruitingIU Health Methodist Hospital
Indianapolis, Indiana, United States
- Ann Jones, MD · Contactannjone@iu.edu
- Ann Jones, MD · Principal investigator
RecruitingUniversity of Iowa Hospitals & Clinics
Iowa City, Iowa, United States
- Hannah Roeder, MD, MPH · Contact319-356-8755hannah-roeder@uiowa.edu
- Hannah Roeder, MD · Principal investigator
RecruitingMassachusetts General Hospital
Boston, Massachusetts, United States
- David J Lin, MD · Contact
- David J Lin, MD · Principal investigator
RecruitingLahey Hospital & Medical Center
Burlington, Massachusetts, United States
- Siddharth Sehgal, MD · Contactsiddharth.sehgal@lahey.org
- Siddharth Sehgal · Principal investigator
RecruitingBaystate Medical Center
Springfield, Massachusetts, United States
- Gottfried Schlaug, MD, PhD · Contact617-319-5953gottfried.schlaug@bhs.org
- Gottfried Schlaug, MD, PhD · Principal investigator
RecruitingUniversity of Michigan
Ann Arbor, Michigan, United States
- Chandramouli Krishnan, PT, PhD · Contactmouli@umich.edu
- Chandramouli Krishnan, PT, PhD · Principal investigator
RecruitingCorewell Heath Butterworth Hospital
Grand Rapids, Michigan, United States
- Malgorzata M Miller, MD · Contact'Malgorzata.miller@corewellhealth.org
- M · Contact
- Malgorzata Miller, MD · Principal investigator
RecruitingMayo Clinic Saint Marys Campus
Rochester, Minnesota, United States
- Muhib Khan, MBBS, MD, RPNI · ContactKhan.Muhib@mayo.edu
- Muhib Khan, MBBS, MD, RPNI · Principal investigator
RecruitingThe Mount Sinai Hospital
New York, New York, United States
- Neha Dangayach, MD · Contactneha.dangayach@mountsinai.org
- Neha Dangayach, MD · Principal investigator
RecruitingStrong Memorial Hospital
Rochester, New York, United States
- Ania Busza, MD, PhD · ContactAnia_Busza@URMC.Rochester.edu
- Ania Busza, MD, PhD · Principal investigator
RecruitingMontefiore Medical Center
The Bronx, New York, United States
- Cynthia Hung, MD · Contactcyhung@montefiore.org
- Cynthia Hung, MD · Principal investigator
RecruitingWestchester Medical Center
Valhalla, New York, United States
- Tomoko Kitago, MD · Contacttomoko.kitago@wmchealth.org
- Tomoko Kitago, MD · Principal investigator
RecruitingDuke University Hospital
Durham, North Carolina, United States
- Wayne Feng, MD · Contact919-684-3801wayne.feng@duke.edu
- Wayne Feng, MD · Principal investigator
RecruitingUniversity of Cincinnati Medical Center
Cincinnati, Ohio, United States
- Oluwole Awosika, MD · Contact513-558-5328awosikoe@ucmail.uc.edu
- Oluwole Awosika, MD · Principal investigator
RecruitingOSU Wexner Medical Center
Columbus, Ohio, United States
- Yousef Hannawi, MD · Contact614-685-7234Yousef.hannawi@osumc.edu
- Yousef Hannawi, MD · Principal investigator
RecruitingPenn State Hershey Medical Center
Hershey, Pennsylvania, United States
- Raymond Reichwein, MD · Contact717-461-1220rreichwein@psu.edu
- Raymond Reichwein, MD · Principal investigator
RecruitingPennsylvania Hospital
Philadelphia, Pennsylvania, United States
- Kelly Sloan, MD · ContactKelly.Sloane@Pennmedicine.upenn.edu
- Kelly Sloan, MD · Principal investigator
RecruitingUPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, United States
- George Wittenberg, MD, PhD · Contact412- 648-4178geowitt@pitt.edu
- George Wittenberg, MD, PhD · Principal investigator
RecruitingMedical University of South Carolina (MUSC)
Charleston, South Carolina, United States
- Kirstin Heise, PhD · Contact843-792-3435heisek@musc.edu
- Kirstin Heise, PhD · Principal investigator
RecruitingPrisma Health Richland Hospital
Columbia, South Carolina, United States
- Forrest Lowe, MD · Contactforrest.lowe@prismahealth.org
- Forrest Lowe, MD · Principal investigator
RecruitingUT Southwestern Medical Center
Dallas, Texas, United States
- Benjamin Nguyen, MD · Contact214-633-4794Benjamin.Nguyen@UTSouthwestern.edu
- Benjamin Nguyen, MD · Principal investigator
RecruitingMemorial Hermann Texas Medical Center
Houston, Texas, United States
- Sean Savitz, MD · Contact617-233-1988Sean.I.Savitz@uth.tmc.edu
- Sean Savitz, MD · Principal investigator
RecruitingUniversity of Utah Healthcare
Salt Lake City, Utah, United States
- Lorie Richards, PhD · Contact352-317-1023lorie.richards@hsc.utah.edu
- Lorie Richards, PhD · Principal investigator
- Jennifer Majersik · Sub-investigator
RecruitingUVA Medical Center
Charlottesville, Virginia, United States
- Chad Aldridge, PT, PhD · ContactCMA7N@hscmail.mcc.virginia.edu
- Chad Aldridge, PT, PhD · Principal investigator
RecruitingHarborview Medical Center
Seattle, Washington, United States
- Nicole Mazwi, MD · Contactnmazwi@uw.edu
- David Tirschwell, MD, MSc · Principal investigator
RecruitingUniversity of Wisconsin University Hospital
Madison, Wisconsin, United States
- Azam S. Ahmed, MD · Contact608-201-0957azam.ahmed@neurosurgery.wisc.edu
- Azam S. Ahmed, MD · Principal investigator
RecruitingAurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States
- Thomas Wolfe, MD · ContactThomas.Wolfe@aah.org
- Thomas Wolfe, MD · Principal investigator
RecruitingFroedtert & Medical College of Wisconsin
Milwaukee, Wisconsin, United States
- Caitlin Moore, MD · Contactcamoore@mcw.edu
- Caitlin Moore, MD · Principal investigator
RecruitingRonald Reagan UCLA Medical Center
Los Angeles, California, United States
WithdrawnUniversity of Maryland Medical Center
Baltimore, Maryland, United States
Active, not recruitingNYU Langone Hospital - Brooklyn
Brooklyn, New York, United States
SuspendedHouston Methodist Hospital
Houston, Texas, United States
WithdrawnRichmond VA Medical Center
Richmond, Virginia, United States
Withdrawn
Study team
Sponsor
Yale University
Study ID 2000040598
Principal investigator
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
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.