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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Surgery
• Intervention / Treatment: Device: Neuralert Monitor

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Brett Cucchiara, MD; Phone Number: (215) 662-6738; Email: cucchiar@pennmedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Hospital of the University of Pennsylvania
      • Principal Investigator: Brett Cucchiara, MD
      • Contact: Stephanie Cummings; Phone Number: 215-662-3363; Email: stephanie.cummings@pennmedicine.upenn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

1. Male or female age ≥ 22 years
2. Admitted or planned admission to one of the participating hospitals and followed by the Cardiothoracic (CT) Surgery or Vascular Surgery services

3. 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
4. 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)

1. Any medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study
2. 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
3. Above the wrist amputation
4. Unwilling to provide informed consent or no legally authorized representative willing to provide consent if the patient is unable
5. Currently imprisoned

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cardiac Surgery Patients OR Neurology Patients	Device: Neuralert Monitor; Device to identify upper extremity asymmetry in patients who are high risk for stroke.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Nursing Response	The time from the nurse receiving an alert to the time they respond after assessing the patient.	Up to 5 days post patient surgery
Time to Generate Alert	The time to successful generation of an alert to staff when asymmetry or low battery is detected.	Up to 5 days post patient surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Neuralert Technologies LLC

Publications and helpful links

General Publications

• Messe SR, Kasner SE, Cucchiara BL, McGarvey ML, Cummings S, Acker MA, Desai N, Atluri P, Wang GJ, Jackson BM, Weimer J. Derivation and Validation of an Algorithm to Detect Stroke Using Arm Accelerometry Data. J Am Heart Assoc. 2023 Feb 7;12(3):e028819. doi: 10.1161/JAHA.122.028819. Epub 2023 Jan 31.

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2024
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: April 5, 2024
• First Submitted That Met QC Criteria: April 10, 2024
• First Posted (Actual): April 16, 2024

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: Neuralert 001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No