Study Flow Diagram
infarction, pain
ADVERSE EVENT, SECONDARY, HYPOPERFUSION, INFARCTION
The time from randomization to study stimulation initiation was recorded for the feasibility outcome. Tolerability was assessed with 2 end points: (1) the rate of patients completing the full study stimulation period (primary tolerability end point); and (2) a formal tolerability technician questionnaire (secondary tolerability end point). Immediately following the stimulation cycle, the technician performed a visual inspection of the skin and completed the tolerability form. The tolerability form consisted of 14 validated cutaneous, neurological, and pain items from the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTAE).The imaging biomarkers of neuroprotection and collateral enhancement were characterized at 2 to 4 hours (early time point) and 24 to 30 hours (late time point) and included improved perfusion (reduction in hypoperfusion region volume); collateral enhancement (increase in quantified relative cerebral blood volume [qrCBV]); and penumbral tissue salvage (tissue at risk not progressing to infarction). The modified Rankin Scale (mRS) was measured at 90 days for exploratory clinical efficacy analysis.