Pilot Study of Acute Stroke Using the Brainpulse™

Completed

Conditions studied: Stroke, Acute

In brief

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 clinical outcomes will be documented as part of the data collected to assess the clinical utility of the BrainPulse device. All eligible patients and healthy volunteers 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 different study groups in an attempt to distinguish stroke from other non-stroke conditions that present with similar symptoms and LVO from non-LVO types of strokes. Further assessments will also be made to evaluate if the BrainPulse can identify the presence of stroke.

Key facts

Study ID

NCT03235271

Run by

Jan Medical, Inc.

People needed

252

Starts

2017-09-10

Expected to finish

2024-08-28

Last updated by the study team

2025-03-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Northwest Community Healthcare — Arlington Heights, Illinois, United States
• NorthShore University Health System — Evanston, Illinois, United States
• University of Cincinnati, Department of Emergency Medicine — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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