Abstract 242: Clinical Validation Trial Of BraiN20® Medical Device. PROMISE20 Study Protocol

Abstract

Introduction N20 somatosensory evoked potential (SEP) response shows high predictive accuracy of functional recovery in patients with Acute Ischemic Stroke (AIS) undergoing endovascular thrombectomy (https://www.clinicaltrials.gov/ct2/show/NCT04099615; SVIN Journal, in press). This capacity is independent and even higher than clinical and advanced imaging variables. This study aims to validate BraiN20®, a portable, non‐invasive, AI‐based device to monitor in real‐time the presence and characteristics of N20 in AIS. Methods 65 patients with AIS and anterior Large Vessel Occlusion (LVO) undergoing EVT within 24 hours from onset are included in three comprehensive stroke centers of Catalonia, Spain. Eligibility criteria are no significant pre‐stroke functional dependence, baseline NIHSS score equal or higher than 6 points, occlusion (mTICI 0‐1) of the intracranial ICA, MCA‐M1 or M2 suitable for EVT per local protocols, without infarct volume restrictions measured by ASPECT score or by CTP/DWI‐MRI prior to EVT . The primary objective is to confirm an optimal/good reliability of N20 registration before EVT higher than 75% by two blind expert neurophysiologists, assuming a true proportion equal to 87.5%. Secondary endpoints are the predictive accuracy of N20 response recorded by BraiN20® before and after EVT on functional outcome evaluated by the mRS at 7 and 90 days and analyzed by using Receiving Operating Characteristic curves. A futility interim analysis is planned after the inclusion of 25% of the sample. Results The trial is sponsored by Time is Brain S.L. and will start early September 2023. Primary endpoint results are expected by the end of this year. Conclusion BraiN20® could be a useful medical device to predict salvageable brain and functional recovery of patients along the stroke chain.