The Neuralert Stroke Monitor Pilot Trial

Launched by NEURALERT TECHNOLOGIES LLC · Apr 10, 2024

Keywords

ClinConnect Summary

The Neuralert Stroke Monitor Pilot Trial is researching a new device called the Neuralert Monitoring System, which aims to detect strokes earlier than current methods. This study is specifically for patients who are hospitalized at the Hospital of the University of Pennsylvania and are considered to be at high risk for strokes due to certain surgical procedures or medical conditions. To participate, individuals must be at least 22 years old and have a planned admission for cardiothoracic or vascular surgery.

During the trial, participants will wear a Neuralert device on each arm for up to five days to monitor their condition. The study will look at how well the device connects to Wi-Fi, how easily data is shared, and whether the device fits smoothly into hospital routines. If you're interested in participating, it's important to know that certain medical conditions might exclude you, and everyone must be able to provide consent to join. This trial will help improve stroke detection and patient care in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 22 years
• • Admitted to or planned admission to the Hospital of the University of Pennsylvania and 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 open surgical or endovascular carotid revascularization
• • 2. Other CT surgery or Vascular surgery procedures in patients with high risk characteristics including: Atrial fibrillation, 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, or age ≥ 80.
• 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 time of 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 representative willing to provide informed consent if the patient is unable