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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor: University of Cincinnati
Study ID: NCT05338697
Status: Recruiting

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Conditions

Stroke
Stroke, Acute
Stroke, Ischemic

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

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 Details

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.

Key Dates

Start date: Jun 18, 2022
Status verified: Oct 2025
Primary completion: Jan 31, 2027
Completion: Oct 31, 2027

Study Design

Enrollment: 657 participants (estimated)

Arms

Arm: Ischemic & Hemorrhagic stroke patients
up to 657 stroke patients

Primary Outcome Measure

Upper Extremity-Fugl Meyer (UE-FM) for AIM 1 [ Time Frame: 90 days post-stroke ]

Central Contacts

Pooja Khatri, MD
203-747-4730
[email protected]
Kalli Beasley, MPH
707-372-6241
[email protected]

Locations (45)

Facility	City	State	ZIP	Site coordinators
Birmingham VA Medical Center	Birmingham	Alabama	35233	Michael Lyerly, MD [email protected] Michael Lyerly, MD (PRINCIPAL_INVESTIGATOR)
University of Alabama	Birmingham	Alabama	35233	Toby Gropen, MD [email protected] Toby Gropen, MD (PRINCIPAL_INVESTIGATOR)
Banner University Medical Center	Tucson	Arizona	85719	Firas Kaddouh, MD, MHS [email protected]
Keck Medical Center of USC	Los Angeles	California	90033	Sook-Lei Liew, PhD, OTR/L [email protected] Sook-Lei Liew, PhD, OTR/L (PRINCIPAL_INVESTIGATOR)
Ronald Reagan UCLA Medical Center	Los Angeles	California	90095	-
Kaiser Permanente Redwood City Medical Center	Redwood City	California	94063	Sheila Chan, MD [email protected] Sheila Chan, MD (PRINCIPAL_INVESTIGATOR)
San Francisco General Hospital	San Francisco	California	94110	Cathra Halabi, MD [email protected] Cathra Halabi, MD (PRINCIPAL_INVESTIGATOR)
UCSF Medical Center	San Francisco	California	94143	Cathra Halabi, MD [email protected] Cathra Halabi, MD (PRINCIPAL_INVESTIGATOR)
Yale New Haven Hospital	New Haven	Connecticut	06511	Rebecca DiBiase, MD [email protected]
MedStar Washington Hospital Center	Washington D.C.	District of Columbia	20010	Matt Edwardson, MD [email protected] 202-687-2184 Matt Edwardson, MD (PRINCIPAL_INVESTIGATOR)
Emory University Hospital	Atlanta	Georgia	30322	Michael Borich, PT, PhD [email protected] 404-640-3150 Michael Borich, PT, PhD (PRINCIPAL_INVESTIGATOR)
Memorial Hospital of Carbondale	Carbondale	Illinois	62901	Andrea Loggini, MD [email protected] Andrea Loggini, MD (PRINCIPAL_INVESTIGATOR)
Advocate Lutheran General Hospital	Park Ridge	Illinois	60068	Anit Behera, MD [email protected]
IU Health Methodist Hospital	Indianapolis	Indiana	46202	Ann Jones, MD [email protected] Ann Jones, MD (PRINCIPAL_INVESTIGATOR)
University of Iowa Hospitals & Clinics	Iowa City	Iowa	52242	Hannah Roeder, MD, MPH [email protected] 319-356-8755 Hannah Roeder, MD (PRINCIPAL_INVESTIGATOR)
University of Maryland Medical Center	Baltimore	Maryland	21201	-
Massachusetts General Hospital	Boston	Massachusetts	02114	David J Lin, MD David J Lin, MD (PRINCIPAL_INVESTIGATOR)
Lahey Hospital & Medical Center	Burlington	Massachusetts	01805	Siddharth Sehgal, MD [email protected] Siddharth Sehgal (PRINCIPAL_INVESTIGATOR)
Baystate Medical Center	Springfield	Massachusetts	01199	Gottfried Schlaug, MD, PhD [email protected] 617-319-5953 Gottfried Schlaug, MD, PhD (PRINCIPAL_INVESTIGATOR)
University of Michigan	Ann Arbor	Michigan	48108	Chandramouli Krishnan, PT, PhD [email protected] Chandramouli Krishnan, PT, PhD (PRINCIPAL_INVESTIGATOR)
Corewell Heath Butterworth Hospital	Grand Rapids	Michigan	49503	Malgorzata M Miller, MD '[email protected] M Malgorzata Miller, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic Saint Marys Campus	Rochester	Minnesota	55902	Muhib Khan, MBBS, MD, RPNI [email protected] Muhib Khan, MBBS, MD, RPNI (PRINCIPAL_INVESTIGATOR)
NYU Langone Hospital - Brooklyn	Brooklyn	New York	11220	-
The Mount Sinai Hospital	New York	New York	10029	Neha Dangayach, MD [email protected] Neha Dangayach, MD (PRINCIPAL_INVESTIGATOR)
Strong Memorial Hospital	Rochester	New York	14642	Ania Busza, MD, PhD [email protected] Ania Busza, MD, PhD (PRINCIPAL_INVESTIGATOR)
Montefiore Medical Center	The Bronx	New York	10467-0121	Cynthia Hung, MD [email protected] Cynthia Hung, MD (PRINCIPAL_INVESTIGATOR)
Westchester Medical Center	Valhalla	New York	10595	Tomoko Kitago, MD [email protected] Tomoko Kitago, MD (PRINCIPAL_INVESTIGATOR)
Duke University Hospital	Durham	North Carolina	27710	Wayne Feng, MD [email protected] 919-684-3801 Wayne Feng, MD (PRINCIPAL_INVESTIGATOR)
University of Cincinnati Medical Center	Cincinnati	Ohio	45219	Oluwole Awosika, MD [email protected] 513-558-5328 Oluwole Awosika, MD (PRINCIPAL_INVESTIGATOR)
OSU Wexner Medical Center	Columbus	Ohio	43210	Yousef Hannawi, MD [email protected] 614-685-7234 Yousef Hannawi, MD (PRINCIPAL_INVESTIGATOR)
Penn State Hershey Medical Center	Hershey	Pennsylvania	17033	Raymond Reichwein, MD [email protected] 717-461-1220 Raymond Reichwein, MD (PRINCIPAL_INVESTIGATOR)
Pennsylvania Hospital	Philadelphia	Pennsylvania	19107	Kelly Sloan, MD [email protected] Kelly Sloan, MD (PRINCIPAL_INVESTIGATOR)
UPMC Presbyterian Hospital	Pittsburgh	Pennsylvania	15213	George Wittenberg, MD, PhD [email protected] 412- 648-4178 George Wittenberg, MD, PhD (PRINCIPAL_INVESTIGATOR)
Medical University of South Carolina (MUSC)	Charleston	South Carolina	29425	Kirstin Heise, PhD [email protected] 843-792-3435 Kirstin Heise, PhD (PRINCIPAL_INVESTIGATOR)
Prisma Health Richland Hospital	Columbia	South Carolina	29203	Forrest Lowe, MD [email protected] Forrest Lowe, MD (PRINCIPAL_INVESTIGATOR)
UT Southwestern Medical Center	Dallas	Texas	75390	Benjamin Nguyen, MD [email protected] 214-633-4794 Benjamin Nguyen, MD (PRINCIPAL_INVESTIGATOR)
Houston Methodist Hospital	Houston	Texas	77030	-
Memorial Hermann Texas Medical Center	Houston	Texas	77030	Sean Savitz, MD [email protected] 617-233-1988 Sean Savitz, MD (PRINCIPAL_INVESTIGATOR)
University of Utah Healthcare	Salt Lake City	Utah	84132	Lorie Richards, PhD [email protected] 352-317-1023 Lorie Richards, PhD (PRINCIPAL_INVESTIGATOR) Jennifer Majersik (SUB_INVESTIGATOR)
UVA Medical Center	Charlottesville	Virginia	22903	Chad Aldridge, PT, PhD [email protected] Chad Aldridge, PT, PhD (PRINCIPAL_INVESTIGATOR)
Richmond VA Medical Center	Richmond	Virginia	23249	Sherita Chapman, MD [email protected]
Harborview Medical Center	Seattle	Washington	98104	Nicole Mazwi, MD [email protected] David Tirschwell, MD, MSc (PRINCIPAL_INVESTIGATOR)
University of Wisconsin University Hospital	Madison	Wisconsin	53792	Azam S. Ahmed, MD [email protected] 608-201-0957 Azam S. Ahmed, MD (PRINCIPAL_INVESTIGATOR)
Aurora St. Luke's Medical Center	Milwaukee	Wisconsin	53215	Thomas Wolfe, MD [email protected] Thomas Wolfe, MD (PRINCIPAL_INVESTIGATOR)
Froedtert & Medical College of Wisconsin	Milwaukee	Wisconsin	53226	Caitlin Moore, MD [email protected] Caitlin Moore, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By condition

Stroke

By specialty

Neurology Brain disorders

By research site

Birmingham VA Medical Center· Birmingham, AL University of Alabama· Birmingham, AL Banner University Medical Center· Tucson, AZ Keck Medical Center of USC· Los Angeles, CA Ronald Reagan UCLA Medical Center· Los Angeles, CA Kaiser Permanente Redwood City Medical Center· Redwood City, CA

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