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Study identifier: NCT05338697 Synced from ClinicalTrials.gov · August 08, 2026
● Study status: RecruitingVERIFY

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

Condition: Stroke · Stroke, Acute · Stroke, Ischemic  ·  Sponsor: University of Cincinnati

PhaseN/A
Planned participants657
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNoCheck eligibility criteria ↓
Where45 locations

Interested? Contact the study team ↓

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

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.

This description comes directly from the study's public registry record.

Talk to the study team

Pooja Khatri, MD  ·  203-747-4730  ·  pooja.khatri@yale.edu

Kalli Beasley, MPH  ·  707-372-6241  ·  Beasleki@ucmail.uc.edu

There is no obligation to join — the study team can answer your questions about taking part.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

Inclusion Criteria: 1. Age 18 years or older 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: 1. UE injury or conditions on paretic side that limited use prior to the stroke 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).

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (45)

Birmingham VA Medical CenterBirmingham, Alabama, United StatesRecruiting
University of AlabamaBirmingham, Alabama, United StatesRecruiting
Banner University Medical CenterTucson, Arizona, United StatesNot Yet Recruiting
Keck Medical Center of USCLos Angeles, California, United StatesRecruiting
Ronald Reagan UCLA Medical CenterLos Angeles, California, United StatesWithdrawn
Kaiser Permanente Redwood City Medical CenterRedwood City, California, United StatesNot Yet Recruiting
San Francisco General HospitalSan Francisco, California, United StatesRecruiting
UCSF Medical CenterSan Francisco, California, United StatesRecruiting
Yale New Haven HospitalNew Haven, Connecticut, United StatesNot Yet Recruiting
MedStar Washington Hospital CenterWashington D.C., District of Columbia, United StatesRecruiting
Emory University HospitalAtlanta, Georgia, United StatesRecruiting
Memorial Hospital of CarbondaleCarbondale, Illinois, United StatesNot Yet Recruiting

+ 33 more locations — full list on the registry record.

More studies in these areas

This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.

BirminghamLos AngelesSan FranciscoWashington D.C.

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