1200 Participants NeededMy employer runs this trial

Neuralert Monitor for Stroke

BC
Overseen ByBrett Cucchiara, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Neuralert Technologies LLC
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a device called the Neuralert Monitor, worn on the wrists to detect early signs of a stroke. It checks for differences in limb movement that might indicate a stroke, aiming to alert doctors quickly and accurately. The goal is to determine if the device can detect strokes more effectively than random alerts while minimizing false alarms. The trial seeks participants hospitalized for heart or blood vessel surgeries who are at high risk for stroke. As an unphased trial, this study allows participants to contribute to innovative research that could enhance stroke detection and improve patient outcomes.

What prior data suggests that the Neuralert Monitor is safe for stroke monitoring?

Research has shown that the Neuralert Monitor is a simple device that helps detect strokes by monitoring differences in arm movement, which can signal an early stroke. Studies have found that users find the device comfortable, as it involves wearing wristbands that monitor stroke symptoms without causing discomfort. Importantly, the Neuralert Monitor rarely gives false alarms, reducing unnecessary worry. The FDA has recognized the device for its innovation and granted it a special designation, indicating it meets specific safety and effectiveness standards. Overall, the Neuralert Monitor is designed as a safe and easy-to-use tool for early stroke detection.12345

Why are researchers excited about this trial?

The Neuralert Monitor is unique because it offers a non-invasive way to detect stroke risk in cardiac surgery patients by identifying upper extremity asymmetry. Unlike standard stroke monitoring methods, which often rely on more invasive and less immediate techniques, this device provides real-time, continuous monitoring. Researchers are excited about this treatment because it has the potential to catch warning signs of a stroke earlier, potentially leading to more timely interventions and better patient outcomes.

What evidence suggests that the Neuralert Monitor is effective for stroke detection?

Research has shown that the Neuralert Monitor, used by participants in this trial, detects strokes much faster than current methods, significantly reducing detection time. Studies indicate that the device analyzes arm movement data to identify unevenness, a potential stroke indicator, with very few false alarms. The Neuralert Monitor's system specifically targets stroke-related unevenness, disregarding other causes. This focus makes it a promising tool for quickly identifying strokes and improving patient outcomes.12456

Are You a Good Fit for This Trial?

Inclusion Criteria

I have had heart valve surgery or a procedure inside my heart.
I need lifelong blood thinners due to a clotting disorder or cancer.
I am 22 years old or older.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Monitoring

Participants are continuously monitored using the Neuralert Monitor to detect asymmetry in extremities and identify potential strokes.

2 years
Continuous monitoring

Follow-up

Participants are monitored for safety and effectiveness after the monitoring period

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Neuralert Monitor

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Cardiac Surgery PatientsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Neuralert Technologies LLC

Lead Sponsor

Trials
1
Recruited
20+

Citations

Study Details | NCT07362303 | Neuralert Stroke Monitor Trial

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 ...

Neuralert Stroke Monitor Trial - ClinicalTrials.Veeva

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 ...

Derivation and Validation of an Algorithm to Detect Stroke ...

Arm movement data can be used to detect asymmetry indicative of stroke in hospitalized patients with a low false alarm rate. Additional studies ...

Neuralert Monitor for Stroke Detection

This trial tests a new device called the Neuralert Monitoring System to determine if it can detect strokes faster than current methods.

Neuralert Stroke Monitor Trial

This study is designed to evaluate the safety and effectiveness of the Neuralert Monitor. This study aims to show that the device produces fewer ...

Arm Movement and the Detection of Stroke

The Neuralert Stroke Detection Monitor detects strokes in ... asymmetry to constantly monitor the patient for possible signs of a stroke.