The Neuralert Stroke Monitor Pilot Trial

Stroke Clinical Trial

Official title:

The Neuralert Stroke Monitor Pilot Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06368193
• Other study ID #: Neuralert 001
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 1, 2024
• Est. completion date: May 1, 2027

Study information

• Verified date: April 2024
• Source: Neuralert Technologies LLC
• Contact: Scott Kasner, MD
• Phone: 215-662-3564
• Email: scott.kasner[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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, clinical usability, and tolerability.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: May 1, 2027
• Est. primary completion date: May 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke
• Surgery

Intervention

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

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Neuralert Technologies LLC

Country where clinical trial is conducted

United States, 

References & 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. do — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Data Aggregation	The percentage of generated accelerometry data that is successfully aggregated online	Up to 5 days post patient surgery
Secondary	Time to alarm reception	The time from detection of asymmetry to receipt of the alarm by the nursing staff.	Up to 5 days post patient surgery
Secondary	Time to alarm reponse	The time from alarm receipt to response from a nurse indicating that the patient has been assessed.	Up to 5 days post patient surgery
Secondary	Stroke detection	Successful detection of a stroke prior to nursing usual care.	Up to 5 days post patient surgery