BraiN20® Monitoring in Acute Stroke Undergoing Thrombectomy

Launched by FUNDACIÓ INSTITUT GERMANS TRIAS I PUJOL · Nov 20, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a device called BraiN20® that monitors brain activity in patients who have had an acute ischemic stroke and are undergoing a procedure called thrombectomy to remove a blood clot. The goal is to see if BraiN20® can accurately predict how well patients will recover after their stroke, based on brain signals it detects. Researchers will include 65 patients who meet specific criteria, such as being at least 18 years old and having a certain level of stroke severity. Importantly, patients must be treated within 24 hours of their symptoms starting.

Participants in the trial can expect to have their brain activity monitored in real-time using the BraiN20® device before and after their thrombectomy. The study is being conducted at three stroke centers in Catalonia, Spain, and aims to confirm that BraiN20® can reliably measure brain signals, which could help doctors understand patients' recovery potential better. The trial is currently recruiting participants, and the first results are anticipated in early 2024. This research could lead to improved care for stroke patients by predicting their chances of recovery more accurately.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Acute ischemic stroke with large anterior vessel occlusion undergoing treatment with EVT according to local protocols.
• • 2. Age ≥18.
• • 3. No significant pre-stroke functional dependence (mRS ≤ 2).
• • 4. 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.
• • 5. Baseline NIHSS score obtained prior to procedure must be equal or higher than 6 points.
• • 6. 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.
• • 7. Any infarct core, without volume restrictions, measured by ASPECT score or by PCT/DWI-MRI prior to EVT.
• • 8. 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:
• • Clinical criteria
• • 1. Patients with a well-documented history of neuromuscular diseases and other neurodegenerative disorders, prior stroke (TIA not excluded) or nervous system tumors that could interfere with SEP assessment.
• • 2. Serious, advanced, or terminal illness with anticipated life expectancy of less than three months.
• • 3. Patients with a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations.
• • 4. Known pregnant women. In case of women of childbearing potential (WOCBP) with no highly effective methods for birth control, a pregnancy test should be performed.
• • Neuroimaging criteria
• • 5. CT or MR evidence of hemorrhage (the presence of microbleeds is allowed).
• • 6. Subjects with occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation).
• • 7. Evidence of intracranial tumor (except small meningioma).
• BraiN20® medical device safety issues:
• • 8. Subjects with a demand-type cardiac pacemaker, defibrillator, or other electrical implant or metal.
• • 9. Patients with suspected or well-known cancerous skin lesion in the area where electrical stimulation will be applied.
• • 10. Patients who have a localized disorder in the wrist and forearm where electrical stimulation is to be applied (i.e., fractures or dislocations).