Monitoring brain activity in stroke patients undergoing thrombectomy

Somatosensory Evoked Potentials (SEP) Monitoring in Patients With Acute Ischemic Stroke (AIS) and Large Anterior Vessel Occlusion (LVO) Undergoing Endovascular Thrombectomy (EVT). A Clinical Validation of the BraiN20® Medical Device.

This study is testing a new device that monitors brain activity in stroke patients during a treatment called thrombectomy to see if it can help doctors better understand who will benefit from the procedure.

Quick facts

• Study type: Observational
• Enrollment: 65 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fundació Institut Germans Trias i Pujol (Academic / other)
• Locations: 3 sites (Badalona, Catalonia and 2 other locations)
• Trial ID: NCT06149754 on ClinicalTrials.gov

What this trial studies

This observational study aims to validate the BraiN20® device, which monitors N20 somatosensory evoked potentials in patients with acute ischemic stroke undergoing mechanical thrombectomy. The study will include 65 patients from three comprehensive stroke centers in Catalonia, Spain, who meet specific eligibility criteria, including a baseline NIHSS score of 6 or higher. The device is designed to provide real-time insights into brain salvageability, potentially improving patient triage and treatment outcomes. By assessing the N20 response, the study seeks to enhance the identification of patients who are likely to benefit from thrombectomy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with acute ischemic stroke and large anterior vessel occlusion who can be treated within 24 hours of symptom onset.

Not a fit: Patients with significant pre-stroke functional dependence or those not meeting the specific eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved patient outcomes by enabling more accurate identification of candidates for thrombectomy.

How similar studies have performed: Other studies have shown promise in using biomarkers for predicting outcomes in stroke treatment, but the specific use of the BraiN20® device is a novel approach.

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).

Where this trial is running

Badalona, Catalonia and 2 other locations

• Hospital Universitari Germans Trias i Pujol — Badalona, Catalonia, Spain (Recruiting)
• Hospital Universitario Vall d'Hebrón — Barcelona, Spain (Recruiting)
• Hospital Universitario Doctor Josep Trueta — Girona, Spain (Not_yet_recruiting)

Study contacts

• Study coordinator: Alicia Martinez-Piñeiro, MD, PhD

Conditions Acute Stroke; Mechanical Thrombectomy; Evoked potentials, Somatosensory; Acute ischemic stroke; Prognosis; Salvageable brain; Functional recovery; Medical device