Actively Recruiting
Neuralert Stroke Monitor Trial
Led by Neuralert Technologies LLC · Updated on 2026-04-01
1200
Participants Needed
1
Research Sites
120 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The Neuralert monitoring system, a non-invasive device worn on each wrist, is designed to provide continuous monitoring and expedited recognition of stroke by identifying asymmetry in the extremities, facilitating patient treatment and improving outcomes. This study is designed to evaluate the safety and effectiveness of the Neuralert Monitor. This study aims to show that the device produces fewer than 2 false alarms per patient per day on average, and that the device detects stroke with a sensitivity significantly greater than a device producing 2 random alerts per day.
CONDITIONS
Official Title
Neuralert Stroke Monitor Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female age 2 years or older
- Admitted or planned admission to a participating hospital and followed by Cardiothoracic or Vascular Surgery services
- Considered at high risk for stroke based on high-risk interventions or procedures during hospitalization, including intracardiac surgery or endovascular procedures, ascending aorta or aortic arch repair, or carotid revascularization
- Or based on other cardiac procedures combined with high-risk medical history such as age 2 80 years, prior stroke or transient ischemic attack, hypercoagulable state requiring lifelong anticoagulation, severely reduced left ventricular ejection fraction less than 30%, anterior left ventricular wall akinesis, or atrial fibrillation
You will not qualify if you...
- Medical or psychological conditions that may compromise safety or participation as judged by the investigator
- Baseline preoperative asymmetric upper extremity weakness with a difference in motor score between arms greater than 0
- Amputation above the wrist
- Unwillingness to provide informed consent or no legal representative to consent if unable
- Currently imprisoned
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19103
Actively Recruiting
Research Team
B
Brett Cucchiara, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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