Status:
COMPLETED
Pilot Study of Acute Stroke Using the Brainpulse™
Lead Sponsor:
Jan Medical, Inc.
Conditions:
Stroke, Acute
Eligibility:
All Genders
18+ years
Brief Summary
The aim of this pilot study is to collect data on stroke patients and non-stroke patients or healthy volunteers using the BrainPulse Stroke Monitor. Subject characteristics, diagnostic procedures and ...
Detailed Description
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 e...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 10 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 28 2024
Estimated Enrollment :
252 Patients enrolled
Trial Details
Trial ID
NCT03235271
Start Date
September 10 2017
End Date
August 28 2024
Last Update
March 7 2025
Active Locations (3)
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1
Northwest Community Healthcare
Arlington Heights, Illinois, United States, 60005
2
NorthShore University Health System
Evanston, Illinois, United States, 60201
3
University of Cincinnati, Department of Emergency Medicine
Cincinnati, Ohio, United States, 45267-0769