The Neuralert Stroke Monitor Pilot Trial

Phase 2

Recruiting

• Conditions: Stroke; Surgery
• Interventions: Device: Neuralert Monitor

• Registration Number: NCT06368193
• Lead Sponsor: Neuralert Technologies LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-05
• Study First Submitted QC: 2024-04-10
• Study First Posted: 2024-04-16
• Status Verified: 2024-11
• Study Start: 2024-11-10
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-15
• Primary Completion: 2026-05-01
• Study Completion: 2027-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cardiac Surgery Patients	Neuralert Monitor	-

Primary Outcome Measures

Name	Time	Method
Time to Nursing Response	Up to 5 days post patient surgery	The time from the nurse receiving an alert to the time they respond after assessing the patient.
Time to Generate Alert	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 Outcome Measures

Name	Time	Method
Number of Strokes Identified	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.
Device Tolerability	Up to 5 days post patient surgery	The tolerability and impact on clinical workflow and patient feedback on tolerability after study completion.

Trial Locations

Locations (1)

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States