Neuralert Monitor for Stroke Detection

Overseen By Scott Kasner, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Neuralert Technologies LLC

Disqualifiers: Asymmetric weakness, Amputation, Unwilling, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the Neuralert Monitoring System to determine if it can detect strokes faster than current methods. Participants will wear the device on each arm for up to five days while researchers assess its compatibility with hospital systems and ease of use. The trial targets patients undergoing heart or blood vessel surgeries who are at high risk for stroke due to conditions like atrial fibrillation or a history of strokes. Individuals who have had heart surgery and are concerned about strokes may find this trial suitable. As a Phase 2 trial, the research focuses on evaluating the device's effectiveness in an initial, smaller group, providing an opportunity to contribute to advancements in stroke detection.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial team or your doctor.

What prior data suggests that the Neuralert Monitoring System is safe for stroke detection?

Research shows that the Neuralert Monitoring System is a non-invasive, lightweight wristband. It detects signs of a stroke by tracking arm movements and can alert hospital staff quickly, often faster than traditional methods.

Since this trial is in its early stages, data on the safety of the Neuralert device remains limited. However, because it doesn't enter the body, it is generally expected to be safe. Non-invasive devices usually pose fewer risks than treatments involving surgery or medication.

In this phase of the trial, researchers are primarily assessing how well the device functions in a hospital setting, including its connectivity and battery life. The focus is more on usability rather than safety concerns. If major safety issues existed, earlier studies likely would have identified them. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Neuralert Monitoring System is unique because it offers a real-time, continuous monitoring approach for stroke detection, which could be a game-changer for cardiac surgery patients. Unlike traditional methods that rely on periodic assessments or subjective symptom reporting, this system uses advanced sensors to detect early signs of a stroke as they happen. Researchers are excited because this could lead to quicker interventions and potentially better outcomes, reducing the risk of severe complications.

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

Studies have shown that the Neuralert Monitoring System, used by participants in this trial, detects strokes about ten times faster than current hospital methods. Quick detection can save lives by identifying a stroke early, leading to better recovery and shorter hospital stays. The system uses wristbands with a smart program that quickly alerts medical staff to stroke symptoms. Research published by the American Heart Association supports the effectiveness of Neuralert's program in hospital patients. These findings suggest that Neuralert could be a powerful tool for detecting and treating strokes. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals who are undergoing surgery and are at risk of stroke. Participants will be monitored using the Neuralert system to detect potential strokes early. The device will be worn on each arm for up to five days, or until battery life ends.

Inclusion Criteria

I have a high-risk health condition like heart issues or a history of blood clots.

I am 22 years old or older.

I will be admitted to the Hospital of the University of Pennsylvania for surgery.

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

I have had an amputation above the wrist on one of my arms.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Monitoring

Participants are monitored using the Neuralert device to detect strokes and assess device connectivity, data transmission, and usability.

Up to 5 days

Continuous monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Neuralert Monitoring System

Trial Overview The trial is testing the Neuralert Monitoring System's ability to detect strokes more quickly than current methods. Patients wear a device on each arm that monitors them continuously, with a focus on Wi-Fi connectivity, data transmission, clinical usability, and comfort.

How Is the Trial Designed?

Group I: Cardiac Surgery Patients Experimental Treatment 1 Intervention

Neuralert Monitoring System is already approved in United States for the following indications:

Approved in United States as Neuralert Monitoring System for:

• Stroke detection in hospitalized patients

Who Is Running the Clinical Trial?

Neuralert Technologies LLC

Lead Sponsor

Trials

1

Recruited

20+

Published Research Related to This Trial

Neurotechnologies, including robotic systems and nerve-stimulating electrodes, show promise in enhancing stroke rehabilitation, but a significant shift in approach is needed to improve outcomes compared to traditional therapies.

Understanding the mechanisms of natural stroke recovery is crucial for developing effective neurotechnological interventions, as current technologies have limitations that need to be addressed for better clinical results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advanced Neurotechnologies for the Restoration of Motor Function. Micera, S., Caleo, M., Chisari, C., et al.[2020]

A feasibility study involving 10 stroke survivors showed that the PAMSys™ wearable technology was well-accepted, with all participants finding it comfortable and easy to use during daily activities for 48 hours.

Stroke survivors demonstrated significantly worse fall risk indicators and lower walking activity compared to age-matched controls, highlighting the potential of wearable technology to monitor and address these issues in recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Objective fall risk detection in stroke survivors using wearable sensor technology: a feasibility study. Taylor-Piliae, RE., Mohler, MJ., Najafi, B., et al.[2018]

The MyHeart consortium is developing a system that combines clothing with embedded biomedical sensors to enhance neurological rehabilitation for stroke patients, allowing for both motor and cognitive training.

This innovative approach enables patients to continue their rehabilitation at home using technology, which supports their recovery process after leaving the intensive care unit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote support for stroke rehabilitation: MyHeart's "neurological rehabilitation" concept. Giorgino, T., Tormene, P., Cattani, B., et al.[2016]

A new wearable sensor system allows therapists to monitor patients' upper limb movements and visualize this data on a dashboard, providing objective insights into patient activity levels and adherence to rehabilitation exercises.

Therapists found the visualized movement data helpful for engaging patients in their rehabilitation process, but noted the need for additional contextual information to better relate the data to patients' daily activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How Therapists Use Visualizations of Upper Limb Movement Information From Stroke Patients: A Qualitative Study With Simulated Information. Ploderer, B., Fong, J., Klaic, M., et al.[2020]

In a study involving 13 participants who had experienced a unilateral ischemic stroke, wearable sensors that provided vibrotactile reminders significantly increased the use of the affected arm after reminders were given.

The positive effect of these reminders on arm activity was sustained throughout the day and over a 6-week home intervention period, suggesting that this approach could be an effective rehabilitation tool for stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Movement Reminders to Encourage Arm Use During Daily Life in Stroke Patients. Mayrhuber, L., Lestoille, M., Andres, SD., et al.[2023]

Wearable technology can significantly enhance stroke rehabilitation by providing objective assessments and monitoring of patients' progress both in clinical settings and at home, which can lead to more personalized therapy plans.

The review highlights the current use of various wearable sensors focused on upper extremity rehabilitation, discussing both the challenges faced in implementation and the opportunities for developing reliable tools to improve recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wearable technology in stroke rehabilitation: towards improved diagnosis and treatment of upper-limb motor impairment. Maceira-Elvira, P., Popa, T., Schmid, AC., et al.[2020]

The manumeter, a novel device combining a sensorized watch and magnetic ring, accurately monitors wrist and hand movements, with 95% of joint angle estimates within 2.4 to 5.8 degrees of actual measurements during a 60-minute trial.

This device shows promise for enhancing the monitoring of hand function in real-world settings, particularly for stroke recovery and other applications, by providing unobtrusive and precise movement data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Manumeter: a non-obtrusive wearable device for monitoring spontaneous use of the wrist and fingers. Rowe, JB., Friedman, N., Bachman, M., et al.[2021]

Recent advances in technology, such as body-worn sensors and neuroimaging, are transforming the approach to arm and hand rehabilitation after stroke, promising more effective clinical trials and interventions.

The review highlights a shift from relying solely on task intensity in rehabilitation to understanding the importance of patient engagement and the underlying neural mechanisms, suggesting a more mature and effective approach to recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Been there, done that, so what's next for arm and hand rehabilitation in stroke? Winstein, C., Varghese, R.[2018]

Citations

1. neuralert.co neuralert.co/

Neuralert – Life-Saving Stroke Detection Neuralert wristbands detect and alert hospital staff to the onset of stroke 10x faster than today's standard of care.

2. chti.upenn.edu chti.upenn.edu/neuralert

Neuralert Neuralert decreases stroke detection time tenfold compared to the current standard of care, saving patient lives, improving outcomes, and reducing hospital ...

3. neuralert.co neuralert.co/news/american-heart-association-publishes-neuralerts-research-regarding-the-use-of-our-algorithm-to-detect-stroke/

American Heart Association publishes Neuralert's research ... Neuralert Technologies is pleased to announce our clinical research regarding the use of our algorithm to detect stroke was published in the Journal of the ...

4. trialx.com trialx.com/clinical-trials/listings/323004/the-neuralert-stroke-monitor-pilot-trial/

The Neuralert Stroke Monitor Pilot Trial This trial aims to demonstrate that the Neuralert Monitoring System will detect strokes before they would be identified by current standard of ...

5. ahajournals.org ahajournals.org/doi/pdf/10.1161/JAHA.122.028819

Derivation and Validation of an Algorithm to Detect Stroke ... Neuralert Technologies, which has licensed the algorithm described in this study to develop a monitor to rapidly detect stroke in hospitalized patients. The ...

6. neuralert.co neuralert.co/how/

How It Works Neuralert is the first lightweight, non-invasive, wearable stroke detection system that continuously monitors for stroke and automatically sends an alert.

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06368193/the-neuralert-stroke-monitor-pilot-trial?activelyRecruiting=false&page=379&id=42&slug=cerebral-ischemia

The Neuralert Stroke Monitor Pilot Trial This trial aims to demonstrate that the Neuralert Monitoring System will detect strokes before they would be identified by current standard ...