Phase
Condition
Thrombosis
Cerebral Ischemia
Stroke
Treatment
Transcranial Magnetic Stimulation (TMS)
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age 18 years or older
Unilateral symptomatic stroke due to ischemia. (Note: Bilateral acute stroke ispermitted if the stroke that is contralateral to the index stroke is asymptomatic).
Motor deficits in the acutely affected UE, defined as a Shoulder Abduction andFinger Extension (SAFE) score ≤ 8 out of 10 points20,61 (i.e., excluding full ornearly 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 studymemo.
Provision of signed and dated informed consent form within 24 to 96 hours of strokeonset, (or time last known well). Note: Participant is considered "enrolled" uponstarting TMS (at least one stimulation is delivered) or starting study-specific MRIpulse sequence (at least one MRI beep occurs)
Stated willingness to comply with all study procedures and availability for theduration of the study, including Day 90 visit which must occur in-person.
Fluent in study approved languages (i.e., English or Spanish)
Exclusion
Exclusion Criteria:
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 verbalcommand
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 (acutetreatment or rehabilitation/recovery intervention) after baseline assessments forVERIFY are initiated
Known or expected inability to maintain follow-up with study procedures through 90days
Cognitive or communication impairment precluding informed consent by theparticipant.
Major medical, neurological, or psychiatric condition that would substantiallyaffect functional status
Non-cerebrovascular diagnosis associated with unlikely survival at 90 days
Pregnancy
Contraindication to noncontrast MRI (certain metallic implants, metallic foreignbodies or severe claustrophobia)
Contraindication to TMS
Implanted electronic cardiac devices (e.g., Automatic ImplantableCardioverter-Defibrillator [AICD] or pacemaker)
Any electronic devices in the body at or above the level of the seventhcervical vertebra (such as cochlear implant, cortical stimulator, deep brainstimulator, vagus nerve stimulator, cervical spine epidural stimulator, orventriculoperitoneal 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 ofsymptom onset (or time last known well).
Study Design
Study Description
Connect with a study center
University of Alabama
Birmingham, Alabama 35233
United StatesSite Not Available
Birmingham VA Medical Center
Birmingham 4049979, Alabama 4829764 35233
United StatesActive - Recruiting
University of Alabama
Birmingham 4049979, Alabama 4829764 35233
United StatesActive - Recruiting
Banner University Medical Center
Tucson 5318313, Arizona 5551752 85719
United StatesSite Not Available
Ronald Reagan UCLA Medical Center
Los Angeles, California 90095
United StatesSite Not Available
San Francisco General Hospital
San Francisco, California 94110
United StatesSite Not Available
UCSF Medical Center
San Francisco, California 94143
United StatesActive - Recruiting
Keck Medical Center of USC
Los Angeles 5368361, California 5332921 90033
United StatesActive - Recruiting
Ronald Reagan UCLA Medical Center
Los Angeles 5368361, California 5332921 90095
United StatesSite Not Available
Kaiser Permanente Redwood City Medical Center
Redwood City 5386834, California 5332921 94063
United StatesSite Not Available
San Francisco General Hospital
San Francisco 5391959, California 5332921 94110
United StatesActive - Recruiting
UCSF Medical Center
San Francisco 5391959, California 5332921 94143
United StatesActive - Recruiting
Yale New Haven Hospital
New Haven 4839366, Connecticut 4831725 06511
United StatesSite Not Available
MedStar Washington Hospital Center
Washington, District of Columbia 20010
United StatesSite Not Available
MedStar Washington Hospital Center
Washington D.C. 4140963, District of Columbia 4138106 20010
United StatesActive - Recruiting
Emory University Hospital
Atlanta, Georgia 30322
United StatesSite Not Available
Emory University Hospital
Atlanta 4180439, Georgia 4197000 30322
United StatesActive - Recruiting
Memorial Hospital of Carbondale
Carbondale 4235193, Illinois 4896861 62901
United StatesSite Not Available
Advocate Lutheran General Hospital
Park Ridge 4905367, Illinois 4896861 60068
United StatesSite Not Available
IU Health Methodist Hospital
Indianapolis 4259418, Indiana 4921868 46202
United StatesSite Not Available
University of Iowa Hospitals & Clinics
Iowa City, Iowa 52242
United StatesSite Not Available
University of Iowa Hospitals & Clinics
Iowa City 4862034, Iowa 4862182 52242
United StatesActive - Recruiting
University of Maryland Medical Center
Baltimore, Maryland 21201
United StatesSite Not Available
University of Maryland Medical Center
Baltimore 4347778, Maryland 4361885 21201
United StatesSite Not Available
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesSite Not Available
Lahey Hospital & Medical Center
Burlington, Massachusetts 01805
United StatesSite Not Available
Baystate Medical Center
Springfield, Massachusetts 01199
United StatesSite Not Available
Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114
United StatesActive - Recruiting
Lahey Hospital & Medical Center
Burlington 4931737, Massachusetts 6254926 01805
United StatesActive - Recruiting
Baystate Medical Center
Springfield 4951788, Massachusetts 6254926 01199
United StatesActive - Recruiting
University of Michigan
Ann Arbor, Michigan 48108
United StatesSite Not Available
Corewell Heath Butterworth Hospital
Grand Rapids, Michigan 49503
United StatesSite Not Available
University of Michigan
Ann Arbor 4984247, Michigan 5001836 48108
United StatesActive - Recruiting
Corewell Heath Butterworth Hospital
Grand Rapids 4994358, Michigan 5001836 49503
United StatesActive - Recruiting
Mayo Clinic Saint Marys Campus
Rochester 5043473, Minnesota 5037779 55902
United StatesSite Not Available
Montefiore Medical Center
Bronx, New York 10467-0121
United StatesSite Not Available
Mount Sinai Hospital
New York, New York 10029
United StatesSite Not Available
NYU Langone Medical Center - Tisch Hospital
New York, New York 10016
United StatesActive - Recruiting
Strong Memorial Hospital
Rochester, New York 14642
United StatesSite Not Available
NYU Langone Hospital - Brooklyn
Brooklyn 5110302, New York 5128638 11220
United StatesSuspended
The Mount Sinai Hospital
New York 5128581, New York 5128638 10029
United StatesActive - Recruiting
Strong Memorial Hospital
Rochester 5134086, New York 5128638 14642
United StatesActive - Recruiting
Montefiore Medical Center
The Bronx 5110266, New York 5128638 10467-0121
United StatesActive - Recruiting
Westchester Medical Center
Valhalla 5142090, New York 5128638 10595
United StatesActive - Recruiting
Duke University Hospital
Durham, North Carolina 27710
United StatesSite Not Available
Duke University Hospital
Durham 4464368, North Carolina 4482348 27710
United StatesActive - Recruiting
University of Cincinnati Medical Center
Cincinnati, Ohio 45219
United StatesSite Not Available
OSU Wexner Medical Center
Columbus, Ohio 43210
United StatesSite Not Available
University of Cincinnati Medical Center
Cincinnati 4508722, Ohio 5165418 45219
United StatesActive - Recruiting
OSU Wexner Medical Center
Columbus 4509177, Ohio 5165418 43210
United StatesActive - Recruiting
Penn State Hershey Medical Center
Hershey, Pennsylvania 17033
United StatesSite Not Available
Pennsylvania Hospital
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania 15213
United StatesSite Not Available
Penn State Hershey Medical Center
Hershey 5193342, Pennsylvania 6254927 17033
United StatesActive - Recruiting
Pennsylvania Hospital
Philadelphia 4560349, Pennsylvania 6254927 19107
United StatesActive - Recruiting
UPMC Presbyterian Hospital
Pittsburgh 5206379, Pennsylvania 6254927 15213
United StatesActive - Recruiting
Medical University of South Carolina (MUSC)
Charleston, South Carolina 29425
United StatesSite Not Available
Prisma Health Richland Hospital
Columbia, South Carolina 29203
United StatesSite Not Available
Medical University of South Carolina (MUSC)
Charleston 4574324, South Carolina 4597040 29425
United StatesActive - Recruiting
Prisma Health Richland Hospital
Columbia 4575352, South Carolina 4597040 29203
United StatesActive - Recruiting
UT Southwestern Medical Center
Dallas, Texas 75390
United StatesSite Not Available
Houston Methodist Hospital
Houston, Texas 77030
United StatesSite Not Available
Memorial Hermann Texas Medical Center
Houston, Texas 77030
United StatesActive - Recruiting
UT Southwestern Medical Center
Dallas 4684888, Texas 4736286 75390
United StatesActive - Recruiting
Houston Methodist Hospital
Houston 4699066, Texas 4736286 77030
United StatesSite Not Available
Memorial Hermann Texas Medical Center
Houston 4699066, Texas 4736286 77030
United StatesActive - Recruiting
University of Utah Healthcare
Salt Lake City, Utah 84132
United StatesSite Not Available
University of Utah Healthcare
Salt Lake City 5780993, Utah 5549030 84132
United StatesActive - Recruiting
UVA Medical Center
Charlottesville, Virginia 22903
United StatesSite Not Available
UVA Medical Center
Charlottesville 4752031, Virginia 6254928 22903
United StatesActive - Recruiting
Richmond VA Medical Center
Richmond 4781708, Virginia 6254928 23249
United StatesSite Not Available
Harborview Medical Center
Seattle, Washington 98104
United StatesSite Not Available
Harborview Medical Center
Seattle 5809844, Washington 5815135 98104
United StatesActive - Recruiting
University of Wisconsin University Hospital
Madison, Wisconsin 53792
United StatesSite Not Available
Froedtert & Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United StatesSite Not Available
University of Wisconsin University Hospital
Madison 5261457, Wisconsin 5279468 53792
United StatesActive - Recruiting
Aurora St. Luke's Medical Center
Milwaukee 5263045, Wisconsin 5279468 53215
United StatesSite Not Available
Froedtert & Medical College of Wisconsin
Milwaukee 5263045, Wisconsin 5279468 53226
United StatesActive - Recruiting

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