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Neuralert Stroke Monitor Trial

This study is testing the Neuralert Monitor, a non-invasive device worn on your wrists. It continuously checks for unevenness in your arms and hands, which could be a sign of a stroke. The goal is to see if the device can quickly alert healthcare workers to a possible stroke, helping patients get treatment sooner. You might be able to join if you are 22 or older, admitted to a participating hospital, and considered at high risk for stroke due to certain medical procedures. The study aims to show the device is safe, has very few false alarms, and can detect strokes much better than random alerts. The current recruitment status is unclear.

Study design
This study plans to enroll 1200 participants to evaluate the Neuralert Monitor. It is an interventional study, meaning participants will receive the device.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your safety and the device's effectiveness will be monitored throughout the study, which is expected to last an average of 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07362303

Neuralert Stroke Monitor Trial

Recruiting
NAAges 22+Interventional
Neuralert Technologies LLC
~1,200 participants
Updated 2026-04-01 on ClinicalTrials.gov
What's tested:Neuralert Monitor

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Efficacy of Device
Measured over through study completion, an average of 2 years
+1 more outcome measured

Conditions

Surgery
Stroke

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Stroke

NCT07362303

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvaniastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Brett Cucchiara, MD
[email protected]
(215) 662-6738
Email the study team

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Eligibility criteria

Inclusion

Interventions or procedures that are high-risk for stroke performed during the hospitalization, which may include:
Intracardiac surgical or endovascular procedures, including valve replacement
Ascending aorta or aortic arch surgical or endovascular repair
Open surgical or endovascular carotid revascularization
Other cardiac procedures along with a high-risk medical history:
Age ≥ 80 years
Prior stroke/ transient ischemic attack (TIA)
Hypercoagulable state (i.e., prior clotting events attributed to active malignancy or a diagnosed thrombophilia) requiring lifelong anticoagulation
Severely reduced left ventricular cardiac ejection fraction (i.e., \<30%) or anterior left ventricular wall akinesis
Atrial fibrillation

What this trial measures

  • Efficacy of Devicethrough study completion, an average of 2 years

    To show that the sensitivity of the Neuralert Monitor exceeds the specified performance goal, and

  • Safety of Devicethrough study completion, an average of 2 years

    To show that the mean number of false alarms/patient/day for the Neuralert Monitor is less than the specified performance goal.