Actively Recruiting

Phase Not Applicable
Age: 22Years +
All Genders
NCT06368193

The Neuralert Stroke Monitor Pilot Trial

Led by Neuralert Technologies LLC · Updated on 2026-01-20

50

Participants Needed

1

Research Sites

124 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

The Neuralert Stroke Monitor Pilot Trial

Who Can Participate

Age: 22Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female age 63 22 years
  • Admitted or planned admission to a participating hospital with Cardiothoracic or Vascular Surgery services
  • Considered high risk for stroke due to high-risk interventions or procedures during hospitalization including intracardiac surgery, aortic repair, or carotid revascularization
  • Other cardiac procedures with high-risk medical history such as age 63 80 years with prior stroke/TIA, hypercoagulable state requiring lifelong anticoagulation, severely reduced left ventricular ejection fraction (<30%) or anterior left ventricular wall akinesis, or atrial fibrillation
  • Admitted with stroke or TIA due to large artery occlusion or severe stenosis not yet revascularized
Not Eligible

You will not qualify if you...

  • Any medical or psychological condition that would compromise safety or participation
  • Baseline preoperative asymmetric upper extremity weakness (difference in NIHSS upper extremity motor score >0)
  • Amputation above the wrist
  • Unwillingness or inability to provide informed consent, including lack of legally authorized representative if unable
  • Currently imprisoned

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

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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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