Pilot Study of Acute Stroke Using the Brainpulseâ„¢


Phase Results N/A

Eligibility Criteria

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.