Acute stroke, “brain attack”, or cerebrovascular accident is the 5th leading cause of death and the 1st leading cause of disability in the world. Stroke can cause permanent loss of function. The most common consequence of acute stroke is movement disorder developed in more than 80% of people who have had a stroke, and 40% have enduring disability. Stroke is recognized as a socially significant problem that requires special attention and the involvement of medical resources both at the stage of treatment and at the stage of patient rehabilitation. Research in this area traditionally attracts attention of specialists from all over the world.
VERIFY (Validation of Early Prognostic Data for Recovery Outcome after Stroke for Future, Higher Yield Trials) is a multicenter, biomarker validation study of upper extremity motor outcome. VERIFY will validate biomarkers in the acute ischemic stroke window of upper extremity (UE) motor outcome, for immediate use in clinical trials. The central hypothesis is that patients have different UE outcomes depending on CMS function, measured as motor evoked potential (MEP) status via transcranial magnetic stimulation (TMS), and on corticomotor system (CMS) structure, measured as corticospinal tract (CST) lesion load via MRI. This biomarker validation study will be performed at as many as 35 acute care hospitals in the United States. 657 participants (557 with ischemic stroke, and 100 with intracerebral hemorrhage).
Aims of the study are the following:
- To externally validate the relationships that TMS and MRI biomarkers of CMS integrity acquired ≤ 7 days after stroke have with 90-day UE motor impairment outcome after ischemic stroke.
- To externally validate the PREP2 prediction tool used ≤ 7 days after stroke to predict 90-day UE functional outcome for individual patients with ischemic stroke.
Stimuli will be delivered using an FDA 510(k)-cleared monophasic stimulator connected to a 70 mm figure-of-eight coil, and MEPs will be recorded using surface electromyography (EMG). Stimulators will be limited to the Neurosoft MEGA-TMS (Neuro-MS) and MagStim devices. This biomarker validation study will be performed at as many as 35 acute care hospitals in the United States and will involve 657 participants (557 with ischemic stroke, and 100 with intracerebral hemorrhage).
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