The Neuralert Stroke Monitor Pilot Trial

Last updated: November 13, 2024
Sponsor: Neuralert Technologies LLC
Overall Status: Active - Recruiting

Phase

2

Condition

Surgery

Cerebral Ischemia

Stroke

Treatment

Neuralert Monitor

Clinical Study ID

NCT06368193
Neuralert 001
  • Ages > 22
  • All Genders

Study Summary

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 Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 22 years

  • Admitted to or planned admission to the Hospital of the University of Pennsylvaniaand 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 opensurgical or endovascular carotid revascularization

  2. Other CT surgery or Vascular surgery procedures in patients with high riskcharacteristics including: Atrial fibrillation, prior stroke/TIA,hypercoagulable state (i.e., prior clotting events attributed to activemalignancy or a diagnosed thrombophilia) requiring lifelong anticoagulation,severely reduced left ventricular cardiac ejection fraction (i.e., <30%) oranterior left ventricular wall akinesis, or age ≥ 80.

Exclusion

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 timeof 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 representativewilling to provide informed consent if the patient is unable

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Neuralert Monitor
Phase: 2
Study Start date:
November 10, 2024
Estimated Completion Date:
May 01, 2027

Connect with a study center

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

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