Validation of Early Prognostic Data for Recovery Outcome After Stroke for Future, Higher Yield Trials
University of Cincinnati
657 participants
Jun 18, 2022
OBSERVATIONAL
Conditions
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
Inclusion Criteria7
- 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)
Exclusion Criteria24
- 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).
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Interventions
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.
Locations(45)
View Full Details on ClinicalTrials.gov
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NCT05338697