The Neuralert Stroke Monitor Pilot Trial

Last updated: January 15, 2026
Sponsor: Neuralert Technologies LLC
Overall Status: Active - Recruiting

Phase

N/A

Condition

Surgery

Stroke

Cerebral Ischemia

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

  1. Male or female age ≥ 22 years

  2. Admitted or planned admission to one of the participating hospitals and followed bythe Cardiothoracic (CT) Surgery or Vascular Surgery services

  3. Considered at high risk for stroke while in the hospital based on:

Ø Interventions or procedures that are high-risk for stroke performed during thehospitalization, 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

Ø Other cardiac procedures along with a high-risk medical history:

  • Age ≥ 80 years · 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

  • Atrial fibrillation

  1. Admitted with a stroke or TIA attributed to large artery occlusion or severestenosis that has not been revascularized.

Exclusion

Exclusion Criteria: (all must be no)

  1. Any medical or psychological conditions that, in the opinion of the investigator,would compromise the subject's safety or successful participation in the study

  2. Baseline preoperative asymmetric upper extremity weakness as assessed by theInvestigator, defined as a differential in the NIHSS upper extremity motor scorebetween the two arms of >0

  3. Above the wrist amputation

  4. Unwilling to provide informed consent or no legally authorized representativewilling to provide consent if the patient is unable

  5. Currently imprisoned

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Neuralert Monitor
Phase:
Study Start date:
December 12, 2024
Estimated Completion Date:
May 01, 2027

Connect with a study center

  • Hospital of the University of Pennsylvania

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Active - Recruiting

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