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Recruiting

NCT Number: NCT06368193

The Neuralert Stroke Monitor Pilot Trial

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.

Recruiting

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Key information

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location status: Recruiting

Location contact

Brett Cucchiara, MD

PRINCIPAL_INVESTIGATOR

Stephanie Cummings

CONTACT

[email protected]

215-662-3363

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Male or female age ≥ 22 years
  • Admitted or planned admission to one of the participating hospitals and followed by the Cardiothoracic (CT) Surgery or Vascular Surgery services
  • Considered at high risk for stroke while in the hospital based on:

Ø 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

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 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
  • Admitted with a stroke or TIA attributed to large artery occlusion or severe stenosis that has not been revascularized.

Exclusion criteria

(all must be no)

  • 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 preoperative asymmetric upper extremity weakness as assessed by the Investigator, defined as a differential in the NIHSS upper extremity motor score between the two arms of >0
  • Above the wrist amputation
  • Unwilling to provide informed consent or no legally authorized representative willing to provide consent if the patient is unable
  • Currently imprisoned

Treatment and study plan

Neuralert Monitor

Device

Device to identify upper extremity asymmetry in patients who are high risk for stroke.

Primary outcomes

  1. Time to Nursing Response

    Time frame: Up to 5 days post patient surgery

    The time from the nurse receiving an alert to the time they respond after assessing the patient.

  2. Time to Generate Alert

    Time frame: Up to 5 days post patient surgery

    The time to successful generation of an alert to staff when asymmetry or low battery is detected.

Secondary outcomes

  1. Number of Strokes Identified

    Time frame: Up to 5 days post patient surgery

    The number of strokes identified by the Neuralert device and the number of strokes identified by usual care. If a stroke is identified at the next clinical evaluation after an alarm occurs, it will be considered to have been detected by the Neuralert device.

  2. Device Tolerability

    Time frame: Up to 5 days post patient surgery

    The tolerability and impact on clinical workflow and patient feedback on tolerability after study completion.

Study contacts

Contact information is provided by the study sponsor or research team.

Brett Cucchiara, MD

CONTACT

[email protected]

(215) 662-6738

Sponsors and collaborators

Lead sponsor

Neuralert Technologies LLC

Industry

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Apr 16, 2024
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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