Abstract Body: Introduction: The VERIFY study will validate the most biologically relevant and primed biomarkers of 90-day upper extremity (UE) motor outcomes in the acute ischemic stroke window that have immediate potential for use in clinical trials. Specifically, the study’s objectives are to: (1) externally validate the association between transcranial magnetic stimulation (TMS) and MRI biomarkers of corticomotor system (CMS) integrity, acquired acutely, with 90-day UE motor impairment, and (2) externally validate the PREP2 prediction tool for forecasting 90-day UE functional outcome using acute stroke data. Our central hypothesis is that UE outcomes differ based on CMS function, assessed by motor evoked potential (MEP) status with TMS, and CMS structure, assessed by acute lesion load on MRI (including 3D-T1). VERIFY will establish the first large-scale, multicenter, prospective dataset of clinical, TMS, and MRI measures within the acute stroke timeframe.
Design: This NIH StrokeNet biomarker validation study is recruiting adults with motor deficits in the acutely affected UE, within 24-96 hours post-stroke onset, at up to 45 acute care hospitals across the U.S. Participants are considered enrolled upon undergoing study-specific TMS or MRI procedures, which are completed within 48-168 hours of onset for MRI and 72-168 hours for TMS. Enrollments without usable data for both MEP status (TMS) and lesion load data on 3D-T1 MRI will be replaced. Primary outcomes are the day-90 UE-Fugl Meyer (UE-FM) and Action Research Arm Test (ARAT) scores. Key exploratory outcomes include the Motor Activity Log (MAL) and modified Rankin Score (mRS) at 90 days.

Sample Size: 657 participants.

Current Enrollments: 267 total
Enrolled and in primary analysis: 260
Ischemic stroke participants: 233
Intracerebral hemorrhage participants: 34

Trial Status: To date, 30 sites are activated, with 7 additional sites pending activation. Enrollment began in July 2022, and recruitment is projected to conclude by fall 2025. The hemorrhagic exploratory cohort enrollment was closed on April 29, 2024, to ensure sufficient power for the primary analysis cohort of (ischemic stroke.