BraiN20® Medical Device in Suspected Acute Stroke Patients

Launched by ALICIA MARTÍNEZ PIÑEIRO · May 17, 2024

Keywords

ClinConnect Summary

The BraiN20® trial is studying a new medical device designed to help doctors quickly assess patients who may be having an acute stroke. The goal is to see if the BraiN20® can accurately predict how well patients will recover after they receive treatment for strokes caused by blocked blood vessels or bleeding in the brain. This study will take place in three major stroke centers in Spain and aims to include patients within 24 hours of their stroke symptoms starting. To qualify, participants should be at least 18 years old, have no major health issues from before the stroke, and be able to receive the BraiN20® assessment without delaying their treatment.

Those who join the study can expect to undergo the BraiN20® evaluation as part of their routine care for stroke. This device may not only help in diagnosing the type of stroke but also improve the speed and effectiveness of treatments. The trial started in March 2024, and results on its effectiveness are expected by the end of the year. If successful, the BraiN20® could change how strokes are managed, leading to better outcomes for patients.

Gender

ALL

Eligibility criteria

• 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).

Trial Officials