Neuralert Stroke Monitor Trial

NCT07362303 | Recruiting

• 1 other identifier: 859883
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Surgery; Stroke

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Length of time to detection of any stroke

  through study completion, an average of 2 years

• Length of time to detection of stroke by Neuralert

  through study completion, an average of 2 years

• Number of alerts caused by stroke (PPV)

  through study completion, an average of 2 years

Other Outcomes (4)

• Number and type of causes of false alarms

  through study completion, an average of 2 years

• Sensitivity of device

  through study completion, an average of 2 years

• Number of care visits

  through study completion, an average of 2 years

Study Arms (1)

Cardiac Surgery Patients

EXPERIMENTAL

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

Device: Neuralert Monitor

Interventions

Neuralert Monitor DEVICE

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.

Cardiac Surgery Patients

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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 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
• Above the wrist amputation
• Unwilling to provide informed consent or no legally authorized representative willing to provide consent if the patient is unable
• Currently imprisoned

Sponsors & Collaborators

• Neuralert Technologies LLC: lead

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19103, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 36718858 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Brett Cucchiara, MD

CONTACT

(215) 662-6738; cucchiar@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: January 23, 2026
• Study Start: March 26, 2026
• Primary Completion (Estimated): January 15, 2028
• Study Completion (Estimated): July 15, 2028
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

US (1)