NCT05338697 Validation of Early Prognostic Data for Recovery Outcome After Stroke for Future, Higher Yield Trials
| NCT ID | NCT05338697 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Yale University |
| Condition | Stroke |
| Study Type | OBSERVATIONAL |
| Enrollment | 657 participants |
| Start Date | 2022-06-18 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 657 participants in total. It began in 2022-06-18 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. VERIFY will create the first multicenter, large-scale, prospective dataset of clinical, transmagnetic stimulation (TMS), and MRI measures in the acute stroke time window.
Eligibility Criteria
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).
Contact & Investigator
Pooja Khatri, MD
PRINCIPAL INVESTIGATOR
Yale University
Frequently Asked Questions
Who can join the NCT05338697 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05338697 currently recruiting?
Yes, NCT05338697 is actively recruiting participants. Contact the research team at pooja.khatri@yale.edu for enrollment information.
Where is the NCT05338697 trial being conducted?
This trial is being conducted at Birmingham, United States, Birmingham, United States, Tucson, United States, Los Angeles, United States and 11 additional locations.
Who is sponsoring the NCT05338697 clinical trial?
NCT05338697 is sponsored by Yale University. The principal investigator is Pooja Khatri, MD at Yale University. The trial plans to enroll 657 participants.
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