The Neuralert Stroke Monitor Pilot Trial

NCT06368193 | Recruiting FDA Device

• 1 other identifier: Neuralert 001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Surgery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Number of Strokes Identified

  Up to 5 days post patient surgery

• Device Tolerability

  Up to 5 days post patient surgery

Study Arms (1)

Cardiac Surgery Patients OR Neurology Patients

EXPERIMENTAL

Device: Neuralert Monitor

Interventions

Neuralert Monitor DEVICE

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

Cardiac Surgery Patients OR Neurology Patients

Eligibility Criteria

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

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, 19104, 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 RESULT

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: April 5, 2024
• First Posted: April 16, 2024
• Study Start: December 12, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)