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RECRUITING

NCT06421337

BraiN20® Medical Device in Suspected Acute Stroke Patients

Sponsor: Alicia Martínez Piñeiro

View on ClinicalTrials.gov

Summary

Time is Brain company (http://www.tibtimeisbrain.com/about\_us/) developed BraiN20®, a medical device to assess the presence and characteristics of the N20 signal of SEP. Investigators have demonstrated a high prognostic accuracy of N20 on functional recovery of patients with acute ischemic stroke (AIS) due to large vessel occlusion (LVO) undergoing endovascular thrombectomy (EVT), the gold standard treatment. The aim if this new project is to validate BraiN20® in global patients presenting with suspected acute ischemic or hemorrhagic stroke in three comprehensive stroke centers in Spain. The primary objective is to establish the predictive performance of the presence of the N20 SEP over functional recovery as the primary outcome measure (likelihood of having a modified Rankin Scale (mRS) score 0-2 at 3 months evaluated by blinded independent raters). The effect will be measured by the metrics sensitivity, specificity, and predictive values, and compared with clinical and imaging predictive models by Receiving Operating Characteristics (ROC) curve analysis in the global population, stroke subtype and stroke mimics. Secondary aims are: 1) to determine the area under the curve (AUC) of the presence of the N20 SEP as biomarker of functional recovery in small subcortical infarctions and in patients with cortical infarctions and no large vessel occlusion; 2) to characterize N20 SEP signal in hemorrhagic stroke and stroke mimics; and 3) to evaluate the discriminant capacity of an explanatory new algorithm combining pre-hospital clinical variables and N20-SEP signal characteristics between ischemic, hemorrhagic and stroke mimics. This project would represent the first pilot study to validate the ability of BraiN20® to predict the functional recovery in the different types of acute stroke but also its ability to discriminate between stroke subtypes. Thus, BraiN20® monitoring could arise as a paradigm shift in acute stroke management, since it would standardize and accelerate patient triage, enable real time monitoring, increase access to EVT treatment and improve its outcome The trial is sponsored by Time is Brain S.L. and started in March 2024. Primary endpoint results are expected by the end of the 2024. BraiN20® could be a useful medical device aiding stroke subtype diagnosis and functional recovery.

Official title: Somatosensory Evoked Potential (SEP) N20 Monitoring With BraiN20® Medical Device for Prediction of Functional Independence Defined as Rankin Scale Score 0-2 in Global Patients With Suspected Acute Stroke.

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

500

Start Date

2024-03-15

Completion Date

2025-03-31

Last Updated

2024-05-20

Healthy Volunteers

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.

Inclusion Criteria: 1. Patients with suspected acute stroke ischemic or hemorrhagic admitted in the emergency department within 24 hours from symptoms onset or from the last time seen normal. 2. Stroke mimics classified after neurologic examination and diagnostic procedures will be also included. 3. Age ≥18. 4. No significant pre-stroke functional dependence (mRS ≤ 2). 5. Baseline NIHSS score obtained prior to procedure must be equal or higher than 1 point. Patients with TIA and full recovery on admission must not be included. 6. Patients in whom BraiN20® monitoring can be performed without delay of acute stroke therapies. 7. Participation in other treatment or diagnostic test clinical trial is allowed if the patients fulfill the inclusion criteria of PROMISE-GLOBAL. 8. Informed consent obtained from patient or acceptable patient surrogate; or the deferred informed consent, to avoid the delay in the start of the stroke emergency therapies. Exclusion Criteria: \- Clinical criteria 1. Patients with a well-documented history of neuromuscular diseases and other severe neurodegenerative disorders (Mild Cognitive Impairment is not exclusion criteria), prior stroke (TIA is not exclusion criteria) or nervous system tumors that could interfere with SEP assessment. 2. Serious, advanced, or terminal illness with an anticipated life expectancy of less than three months. 3. Women in the premenopausal period. \- Neuroimaging criteria 4. Acute infarct volume (ASPECTS) or ICH volume (AxBxC/2) on plane CT should be measured but they are not exclusion criteria and should not preclude any specific treatment according to local protocols (i.e., mechanical thrombectomy, hemicraniectomy or ICH evacuation). 5. Evidence of intracranial tumor (except small meningioma). \- BraiN20® medical device safety issues: 6. Subjects with a demand-type cardiac pacemaker, defibrillator, or other electrical implant or metal. 7. Patients with suspected or well-known cancerous skin lesions in the area where electrical stimulation is to be applied. 8. Patients who have a localized disorder in the wrist and forearm where electrical stimulation is to be applied (i.e., fractures or dislocations, vein puncture).

Locations (3)

Hospital Universitari de la Santa Creu i Sant Pau

Barcelona, Spain

Hospital Universitari Arnau de Vilanova

Lleida, Spain

Hospital Universitario La Princesa

Madrid, Spain