BraiN20® Medical Device in Suspected Acute Stroke Patients

NARecruitingINTERVENTIONAL
Enrollment

500

Participants

Timeline

Start Date

March 15, 2024

Primary Completion Date

December 31, 2024

Study Completion Date

March 31, 2025

Conditions
Acute Stroke
Interventions
DEVICE

BraiN20(R)

"SEP monitoring will be carried out using the BraiN20® medical device and appropriate electrodes. SEP of both median nerves will be recorded, transferred, and stored to the internal card for their evaluation. BraiN20® Medical Device provides an automatic reading of the presence and feature of a N20 response both ipsilateral and contralateral (as control) to the cerebral hemisphere affected by the stroke and do not require specific training. Furthermore, the device provides an outcome prediction (percentage of likelihood of having mRS ≤ 2 day 7 and 90 after stroke onset) based on an internal algorithm.~BraiN20® measures one N20 wave per 33 seconds. Scalp electrodes are easily embedded on a headband and the wrist electrodes on a glove."

Trial Locations (3)

25198

RECRUITING

Hospital Universitari Arnau de Vilanova, Lleida

28006

RECRUITING

Hospital Universitario La Princesa, Madrid

08025

RECRUITING

Hospital Universitari de la Santa Creu i Sant Pau, Barcelona

All Listed Sponsors
lead

Alicia Martínez Piñeiro

OTHER