Pilot Study of Acute Stroke Using the Brainpulse™
Pilot Study of Acute Stroke Using the Brainpulse™
The aim of this pilot study is to collect data on stroke patients using the BrainPulse Stroke
 Monitor. Patient characteristics, diagnostic procedures and clinical outcomes will be
 documented as part of the data collected to assess the clinical utility of the BrainPulse
 device. All eligible patients will be enrolled and assigned to a study Group based on
 confirmation of their diagnosis: Acute Ischemic Stroke, Hemorrhagic Stroke, Transient
 Ischemic Attack or No Stroke. The data collected from the BrainPulse will be compared across
 the four different study groups in an attempt to distinguish stroke from other non-stroke
 conditions that present with similar symptoms. Further assessments will also be made to
 evaluate if the BrainPulse can distinguish between hemorrhagic and ischemic stroke.
The study is a prospective, non-randomized, non-blinded, hospital-based study of patients
 presenting with acute stroke symptoms within 24 hours of symptom onset (last known normal or
 actual time) as evidenced by radiological imaging. The study will be executed in two parts:
 Study Part I and Study Part II. Each study part 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 consented and 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 one hour 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 BrainPulse recording within four hours after intervention along with a
 neurological exam. 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:

 -  1. Male or female subjects between 18 and 89 years of age 2. Patient undergoes or will
 undergo radiological imaging (CT/MR) as part of stroke evaluation 3. Demonstrated at
 least 1 of the following symptoms:

 1. Hemiparesis, monoparesis, or quadriparesis

 2. Hemisensory deficits

 3. Monocular/binocular visual loss

 4. Visual field deficits

 5. Diplopia

 6. Dysarthria

 7. Facial droop

 8. Ataxia

 9. Vertigo

 10. Aphasia

 11. Severe and sudden onset of headache

 12. Nausea, and/or vomiting

 13. Dizziness

 14. Altered or loss of consciousness

 15. Imbalance/ Incoordination 4. Last known normal or actual time point, whichever is
 known, since commencement of symptoms < 24 hours prior to enrollment 5. Signed
 informed consent, and/or have a legally authorized representative willing to
 provide informed consent on behalf of the subject

 Exclusion Criteria:

 -  1. Not a candidate for radiological imaging (CT/MR) or angiography (CTA/MRA/DSA) 2.
 Patient meets the hospital criteria for brain death 3. Wound or laceration on the head
 in the area of one of the BrainPulse sensors that would impede use of the BrainPulse
 device 4. Any serious medical, social or psychological condition that in the opinion
 of the investigator would disqualify a patient from participation 5. Symptoms due to
 head trauma 6. Prior history of stroke 7. Any neuro-intervention commenced or
 completed between admission and time of enrollment 8. If all planned radiological
 imaging (CT and/or MR) and angiography (CTA, MRA or DSA) are complete, does not
 satisfy the eligibility criteria for groups A, B, C, and D.