BraiN20® Medical Device in Suspected Acute Stroke Patients (NCT06421337) | Clinical Trial Compass
RecruitingNot Applicable
BraiN20® Medical Device in Suspected Acute Stroke Patients
Spain500 participantsStarted 2024-03-15
Plain-language 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.
Who can participate
Age range18 Years – 100 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Stroke mimics classified after neurologic examination and diagnostic procedures will be also included.
✓. Age ≥18.
✓. No significant pre-stroke functional dependence (mRS ≤ 2).
✓. 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.
✓. Patients in whom BraiN20® monitoring can be performed without delay of acute stroke therapies.
✓. Participation in other treatment or diagnostic test clinical trial is allowed if the patients fulfill the inclusion criteria of PROMISE-GLOBAL.
✓. 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.
✕. 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.
✕. Serious, advanced, or terminal illness with an anticipated life expectancy of less than three months.
✕. Women in the premenopausal period.
✕. 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).
✕. Evidence of intracranial tumor (except small meningioma).
✕. Subjects with a demand-type cardiac pacemaker, defibrillator, or other electrical implant or metal.
✕. Patients with suspected or well-known cancerous skin lesions in the area where electrical stimulation is to be applied.
✕. 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).