BraiN20® device for assessing stroke patients

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.

This study is testing a new device that measures brain signals in stroke patients to see if it can help predict their recovery and improve treatment decisions.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 500 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: Fundació Institut Germans Trias i Pujol (other)
• Locations: 3 sites (Barcelona and 2 other locations)
• Trial ID: NCT06421337 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the BraiN20® medical device, which measures the N20 signal of somatosensory evoked potentials (SEP) to predict functional recovery in patients with suspected acute ischemic or hemorrhagic stroke. Conducted in three comprehensive stroke centers in Spain, the study aims to validate the device's prognostic accuracy compared to standard clinical and imaging assessments. By providing real-time monitoring, the trial seeks to optimize patient selection for endovascular thrombectomy (EVT), the gold standard treatment for acute stroke. The primary outcome will be assessed using the modified Rankin Scale (mRS) at three months post-treatment.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with suspected acute ischemic or hemorrhagic stroke who present within 24 hours of symptom onset.

Not a fit: Patients with significant pre-stroke functional dependence or those who cannot undergo BraiN20® monitoring without delaying acute stroke therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the ability to predict recovery outcomes in stroke patients, leading to improved treatment decisions and patient care.

How similar studies have performed: Previous studies, such as the PROMISE trial, have shown promising results using similar neurophysiological techniques to improve diagnostic accuracy in acute stroke management.

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).

Where this trial is running

Barcelona and 2 other locations

• Hospital Universitari de la Santa Creu i Sant Pau — Barcelona, Spain (RECRUITING)
• Hospital Universitari Arnau de Vilanova — Lleida, Spain (RECRUITING)
• Hospital Universitario La Princesa — Madrid, Spain (RECRUITING)

Study contacts

• Study coordinator: Alicia Martinez, MD, PhD

Conditions: Acute Stroke, Somatosensory evoked potentials, Acute stroke ischemic, Acute stroke hemorrhagic, Stroke mimics, Prognosis, Functional recovery, Medical device