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BraiN20® Monitoring in Acute Stroke Undergoing Thrombectomy

Spain65 participantsStarted 2023-09-15

Plain-language summary

N20 somatosensory evoked potential (SEP) response shows high predictive accuracy of functional recovery in patients with acute ischemic stroke (AIS) undergoing endovascular thrombectomy (EVT). This capacity is independent and even higher than clinical and advanced imaging variables. This study aims to validate BraiN20®, a portable, non-invasive, automatic device to monitor in real-time the presence and characteristics of N20 in AIS patients. 65 patients with AIS and anterior LVO undergoing EVT within 24 hours from onset will be included in three comprehensive stroke centers of Catalonia, Spain. Eligibility criteria are no significant pre-stroke functional dependence, baseline National of Institute of Health Stroke Scale (NIHSS) score equal or higher than 6 points, occlusion (modified Thrombolysis in Cerebral Infarction, (mTICI) 0-1) of the intracranial internal carotid artery (ICA), middle cerebral artery (MCA)-M1 or M2 suitable for EVT per local protocols, without infarct volume restrictions measured by Alberta Stroke Program Early CT (ASPECT) score or by Perfusion Computed Tomography (PCT)/Diffusion Weighted Imaging-Magnetic Resonance Imaging(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 (ROC). A futility interim analysis is planned after the inclusion of 25% population. The trial is sponsored by Time is Brain S.L. and started in September 2023. Primary endpoint results are expected for the first quarter of 2024. BraiN20® could be a useful medical device to predict salvageable brain and functional recovery of patients along the stroke chain.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Acute ischemic stroke with large anterior vessel occlusion undergoing treatment with EVT according to local protocols.
✓. Age ≥18.
✓. No significant pre-stroke functional dependence (mRS ≤ 2).
✓. Patient treatable within 24 hours of symptom onset. Symptoms onset is defined as the time the patient was last seen well, and treatment point as the time of arterial puncture.
✓. Baseline NIHSS score obtained prior to procedure must be equal or higher than 6 points.
✓. Occlusion (mTICI 0-1) of the intracranial ICA (distal ICA or T occlusions), MCA M1 segment or M2 suitable for EVT, as evidenced by CTA or MRA with or without concomitant cervical carotid occlusion or stenosis.
✓. Any infarct core, without volume restrictions, measured by ASPECT score or by PCT/DWI-MRI prior to EVT.
✓. Informed consent obtained from patient or acceptable patient surrogate; or the deferred informed consent, to avoid the delay in the start of the mechanical thrombectomy.

Exclusion criteria

What they're measuring

Reliability of the BraiN20® Medical Device

Timeframe: Prior to mechanical thrombectomy and at the end of the procedure

Trial details

NCT IDNCT06149754

SponsorFundació Institut Germans Trias i Pujol

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-02-28

Contact for this trial

Alicia Martinez-Piñeiro, MD, PhD

0034662121408 amartinezp.germanstrias@gencat.cat

View on ClinicalTrials.gov More Acute Stroke trials