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 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.