Pilot Study of Acute Stroke Using the Brainpulse™

The study is a prospective, non-randomized, non-blinded, hospital-based study of patients presenting with acute stroke symptoms within 48 hours of symptom onset (last known normal or actual time) as evidenced by radiological imaging. The study will be executed in two parts: Study Phase I and Study Phase II. Each study phase will consist of the same sequence of events and study procedures. The first part of the study is designed to enroll a smaller sample size to evaluate the feasibility of incorporating the BrainPulse device in the Stroke patient care workflow.

Patients will be consecutively recruited and once patients have met eligibility, they will be assigned to one of the four study Groups based on their confirmed clinical diagnosis. Each subject will complete one BrainPulse recording before neuro-intervention and within four hours of IV pharmacologic intervention. All subjects will also complete comprehensive neurological, cognitive and NIH Stroke Scale (NIHSS) assessments. Additionally, Ischemic Stroke subjects (Group A) that receive neuro-intervention will complete one additional, and optional BrainPulse recording along with a neurological exam after intervention. If these procedures have been completed as part of standard of care, the data can be captured directly from the medical records. If such procedures were not conducted as part of hospital's standard of care, they will need to be completed for the purpose of the study.

Inclusion criteria

• Male or female subjects 18 years or older
• Patient undergoes or will undergo radiological imaging (CT/MR) as part of stroke evaluation (n/a for Group D2)
• Demonstrated at least 1 of the following symptoms (n/a for Group D2):

• Hemiparesis, monoparesis, or quadriparesis
• Hemisensory deficits
• Monocular/binocular visual loss
• Visual field deficits
• Diplopia
• Dysarthria
• Facial droop
• Ataxia
• Vertigo
• Aphasia
• Severe and sudden onset of headache
• Nausea, and/or vomiting
• Dizziness
• Altered or loss of consciousness
• Imbalance/ Incoordination
• Last known normal or actual time point, whichever is known, since commencement of symptoms < 48 hours prior to enrollment (n/a for Group D2)
• Consent procedures followed per applicable IRB approvals at site

Exclusion criteria

• Not a candidate for radiological imaging (CT/MR) or angiography (CTA/MRA/DSA) (n/a for Group D2)
• Patient meets the hospital criteria for brain death
• Wound or laceration on the head in the area of one of the BrainPulse sensors that would impede use of the BrainPulse device
• Any serious medical, social or psychological condition that in the opinion of the investigator would disqualify a patient from participation
• Symptoms due to head trauma
• IV tPA commenced or completed > 4 hours ago
• Any neuro-intervention commenced or completed between admission and time of enrollment
• If does not satisfy the eligibility criteria for groups A, B, C, and D.