The Neuralert Stroke Monitor Pilot Trial

Description

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.

Conditions

Stroke, Surgery

Study Overview

Study Details

Study overview

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.

The Neuralert Stroke Monitor Pilot Trial

The Neuralert Stroke Monitor Pilot Trial

Condition
Stroke
Intervention / Treatment

-

Contacts and Locations

Philadelphia

Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States, 19104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

22 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Neuralert Technologies LLC,

Study Record Dates

2027-05-01