RecruitingNot ApplicableNCT07362303

Neuralert Stroke Monitor Trial

Sponsor

Neuralert Technologies LLC

Enrollment

1,200 participants

Start Date

Mar 26, 2026

Study Type

INTERVENTIONAL

Conditions

Surgery Stroke

Summary

The Neuralert monitoring system, a non-invasive device worn on each wrist, is designed to provide continuous monitoring and expedited recognition of stroke by identifying asymmetry in the extremities, facilitating patient treatment and improving outcomes. This study is designed to evaluate the safety and effectiveness of the Neuralert Monitor. This study aims to show that the device produces fewer than 2 false alarms per patient per day on average, and that the device detects stroke with a sensitivity significantly greater than a device producing 2 random alerts per day.

Eligibility

Min Age: 22 Years

Inclusion Criteria13

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:
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
Other cardiac procedures along with a high-risk medical history:
Age ≥ 80 years
Prior stroke/ transient ischemic attack (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

Exclusion Criteria5

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

Print for Your Doctor

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICENeuralert Monitor

The Neuralert monitoring system, a non-invasive device worn on each wrist, is designed to provide continuous monitoring for asymmetry in the extremities, sending an alert to healthcare workers upon identification, thus expediting recognition of stroke.