Neuralert Stroke Monitor Trial

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Estimated): 1200
• 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, 19103
      • Recruiting
      • Hospital of the University of Pennsylvania
      • Contact: Stephanie Cummings; Phone Number: 215-995-0238; Email: stephrcummings@gmail.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria: (all must be yes)

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:

   • 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 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; Device: Neuralert Monitor Device to identify upper extremity asymmetry in patients who are high risk for stroke.	Device: Neuralert 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of Device	To show that the sensitivity of the Neuralert Monitor exceeds the specified performance goal, and	through study completion, an average of 2 years
Safety of Device	To show that the mean number of false alarms/patient/day for the Neuralert Monitor is less than the specified performance goal.	through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of time to detection of any stroke	Time from last known normal to detection of any stroke with weakness	through study completion, an average of 2 years
Length of time to detection of stroke by Neuralert	Time from last known normal to detection by the Neuralert Monitor of any stroke with weakness	through study completion, an average of 2 years
Number of alerts caused by stroke (PPV)	How often an alert is caused by confirmed stroke	through study completion, an average of 2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and type of causes of false alarms	A false alarm is defined as any alarm that does not result in a clinical diagnosis of stroke after the next evaluation by the clinical team	through study completion, an average of 2 years
Sensitivity of device	Sensitivity of device for detection of any stroke, regardless of whether the stroke includes asymmetric weakness	through study completion, an average of 2 years
Number of care visits	Number of usual care visits documented in the electronic health record	through study completion, an average of 2 years
Number and type of adverse events	Any adverse events collected during the study	through study completion, an average of 2 years

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): March 26, 2026
• Primary Completion (Estimated): January 15, 2028
• Study Completion (Estimated): July 15, 2028

Study Registration Dates

• First Submitted: December 8, 2025
• First Submitted That Met QC Criteria: January 15, 2026
• First Posted (Actual): January 23, 2026

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 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: 859883

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No