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The Neuralert Stroke Monitor Pilot Trial

The Neuralert Stroke Monitor Pilot Trial

Recruiting
22 years and older
All
Phase 2

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Overview

This trial aims to demonstrate that the Neuralert Monitoring System will detect strokes before they would be identified by current standard of care. Each patient will be monitored for up to five days, depending on device connectivity or battery duration. Each monitoring session will consist of wearing a Neuralert device on each arm. For this pilot trial, we are interested in learning about Wi-Fi connectivity, successful data transmission, integration into clinical workflow, usability and tolerability.

Eligibility

Inclusion Criteria:

  • Age ≥ 22 years
  • Admitted to or planned admission to the Hospital of the University of Pennsylvania and followed by the Cardiothoracic (CT) Surgery or Vascular Surgery services
  • Considered at high risk for stroke while in the hospital based on:
    1. Interventions or procedures performed during the hospitalization including: Intracardiac surgical or endovascular procedures including valve replacement, ascending aorta or aortic arch surgical or endovascular repair, and open surgical or endovascular carotid revascularization
    2. Other CT surgery or Vascular surgery procedures in patients with high risk characteristics including: Atrial fibrillation, prior stroke/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, or age ≥ 80.

Exclusion Criteria:

  • Any medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.
  • Baseline asymmetric upper extremity weakness as assessed by the study team at time of enrollment, defined as an NIHSS upper extremity motor score >0 in either arm.
  • A limb amputation above the wrist in the upper extremities
  • Unwilling to provide informed consent and no legally authorized representative willing to provide informed consent if the patient is unable

Study details
    Stroke
    Surgery

NCT06368193

Neuralert Technologies LLC

16 October 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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