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BraiN20® Monitoring in Acute Stroke Undergoing Thrombectomy

NCT06149754 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 65

Last updated 2023-11-29

No results posted yet for this study

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.

Conditions

  • Acute Stroke
  • Mechanical Thrombectomy

Interventions

DEVICE

BraiN20(R) monitoring of N20 somatosensory evoked potential

N20 monitoring will be carried out using the BraiN20 medical device and appropriate electrodes. The device measures one N20 wave per 33 seconds. Scalp electrodes will be located on band and wrist electrodes on a globe. The device provides an automatic reading of N20 and outcome prediction and do not require a specific training.

Sponsors & Collaborators

  • European Innovation Council

    collaborator OTHER

  • Anagram-ESIC

    collaborator UNKNOWN

  • Fundació Institut Germans Trias i Pujol

    lead OTHER

Principal Investigators

  • Antoni Dávalos, Prof. MD.PhD · Fundació Institut d'Investigació en Ciències de la Salut Germans Trias iPujol

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-15
Primary Completion
2024-02-28
Completion
2024-05-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06149754 on ClinicalTrials.gov