O29/279 Clinical validation trial of BraiN20(R), a medical device to predict functional recovery in patients with acute ischemic stroke undergoing endovascular thrombectomy. PROMISE20 Study Protocol

Introduction

N20 somatosensory evoked potential (SEP) response shows high predictive accuracy of functional recovery in patients with acute ischemic stroke (AIS) undergoing endovascular thrombectomy (EVT) (https://www.clinicaltrials.gov/ct2/show/NCT04099615). This capacity is independent and higher than clinical and advanced imaging variables.

Aim of Study

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 undergoing EVT within 24 hours from onset are included in three comprehensive stroke centers. Eligibility criteria are no significant pre-stroke functional dependence, baseline NIHSS score ≥ 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 ROC 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 July 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.

Disclosure of Interest

Co-Founder and CEO of Time is Brain S.L.