Brain Monitoring Device for ICU Patients

Overseen By Leslie Melo, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Must be taking: Sedative drips

Disqualifiers: Hearing problems, Polysubstance abuse, others

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

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

Compensation: Varies

Number of Visits: Unknown

Duration: Average 14 days

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates a device called Neurosteer, which tracks brain activity in ICU patients who are sedated and on ventilators. The goal is to determine if this device provides results comparable to current methods for monitoring patient sedation and alertness. Participants include those with sudden brain injuries, such as strokes or trauma, and those with conditions like severe infections or respiratory issues. It suits patients on sedative drips who are expected to remain in the ICU for at least two days. As an unphased trial, this study allows patients to contribute to innovative research that could enhance monitoring techniques in critical care settings.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants are expected to be on sedative drips like propofol, midazolam, or fentanyl, so you may need to continue those if applicable.

What prior data suggests that this brain monitoring device is safe for ICU patients?

Research has shown that the Neurosteer brain monitoring system is safe for use. The FDA has approved this system to track brain activity with a small, portable device. Earlier tests used a sticky strip on the forehead and a tiny sensor to collect data wirelessly. These studies reported no major side effects, indicating that the device is generally well-tolerated. As a non-invasive method, it typically poses a low risk for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Neurosteer Bedside Monitoring System because it offers a real-time, continuous monitoring approach for patients with and without acute neurological injuries in the ICU. Unlike traditional methods that might involve periodic checks or rely heavily on invasive procedures, this system allows for non-invasive, ongoing brain activity monitoring at the bedside. This innovative method could enable faster detection of neurological changes and more timely interventions, potentially improving patient outcomes in critical care settings.

What evidence suggests that the Neurosteer brain monitoring device is effective for monitoring delirium, sedation, and agitation in ICU patients?

Research has shown that the Neurosteer Bedside Monitoring System, which uses a simple EEG attached to the forehead, can effectively track brain activity in ICU patients. This trial will evaluate the system's effectiveness in two groups: NSICU patients with acute neurological injuries (ANI) and those without ANI. The device provides real-time information on brain function, including levels of sedation, confusion, and restlessness. Studies suggest it might offer more accurate monitoring than traditional methods like the Richmond Agitation-Sedation Scale (RASS) and CAM-ICU assessments. The Neurosteer system is non-invasive and easy to use, with data sent wirelessly for quick analysis. Early findings indicate it could improve patient care by allowing better monitoring and adjustment of treatment in critical care settings. ^{1 2 3 5 6}

Who Is on the Research Team?

Neha S Dangayach, MD, MSCR, FNCS, FAAN, DCE'21

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for ICU patients, both with and without acute neurological injuries (ANI), who are intubated and sedated. It aims to include a total of 100 participants, split evenly between those with ANI and those without.

Inclusion Criteria

My gender identity includes transgender or intersex.

Provision of signed and dated informed consent form from patient and/or LAR, including stated willingness to comply with all study procedures and availability for the duration of the study

I am on a ventilator and expected to stay in the hospital for at least 2 days on sedatives.

Exclusion Criteria

I have a rash on my forehead.

History of polysubstance abuse

I have severe memory loss that affects my daily life.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Upon admission to NSICU

Treatment

Participants receive the Neurosteer brain monitoring device intervention during their NSICU stay

Average 14 days

Continuous monitoring during NSICU stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

Not specified

What Are the Treatments Tested in This Trial?

Interventions

• Neurosteer Bedside Monitoring System

Trial Overview The study tests Neurosteer's EEG device designed to monitor brain activity related to delirium, sedation, and agitation. All patients will use the device which will be compared against standard monitoring scales like RASS & CAM-ICU.

How Is the Trial Designed?

Group I: NSICU Patients with Acute Neurological Injuries (ANI) Active Control 1 Intervention

ANI are participants having Acute Ischemic Stroke (AIS), Intracerebral Hemorrhage, Subarachnoid Hemorrhage (SAH), Status Epileptics, Traumatic Brain Injury (TBI), Brain Tumors, Meningitis/encephalitis, post cardiac arrest hypoxic ischemic encephalopathy. All participants will be set up with the Neurosteer bedside monitoring system.

Group II: NSICU Patients without Acute Neurological Injuries (ANI) Active Control 1 Intervention

Participants without ANI to have neuromuscular disorders such as myasthenia gravis, spine surgery, septic shock, acute respiratory distress syndrome, and Hemorrhagic shock ex. from gastrointestinal bleeding. All participants will be set up with the Neurosteer bedside monitoring system.

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

Approved in United States as Neurosteer Bedside Monitoring System for:

• Monitoring delirium, sedation, and agitation in intubated and sedated ICU patients

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Neurosteer Ltd.

Industry Sponsor

Trials

6

Recruited

330+

Published Research Related to This Trial

A study involving 16 adults who had a stroke found that single-channel EEG recordings taken within 72 hours can effectively predict functional outcomes, correlating well with established measures of stroke severity.

Acute theta wave values from the EEG were associated with good recovery outcomes, showing predictive values similar to those obtained from traditional neurological examinations, suggesting that EEG could be a valuable tool in early stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predicting functional outcomes after stroke: an observational study of acute single-channel EEG. Rogers, J., Middleton, S., Wilson, PH., et al.[2021]

A new simplified EEG recording method, called point-of-care EEG (pocEEG), has been developed for use in pediatric emergency departments to quickly diagnose non-convulsive status epilepticus (NCSE), which is often missed in critically ill children.

This cost-effective and space-efficient pocEEG system allows for rapid neuromonitoring, improving the chances of timely diagnosis and treatment for CNS disorders when traditional EEG methods are not available.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating Neuromonitoring in Pediatric Emergency Medicine: Exploring Two Options for Point-of-Care Electroencephalogram (pocEEG) via Patient Monitors-A Technical Note. Simma, L., Romano, F., Schmidt, S., et al.[2023]

The novel wireless eight-channel EEG headset, tested on 52 patients in a neuro-ICU, showed comparable detection of EEG patterns to standard 10/20 EEG systems, particularly excelling in identifying seizure activity (98% match).

The continuous EEG monitoring with the wireless headset detected the same or additional relevant EEG patterns in 89% of patients, suggesting it is a valuable tool for long-term monitoring in patients with consciousness disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a new wireless technique for continuous electroencephalography monitoring in neurological intensive care patients. Meyer, M., Fuest, S., Krain, D., et al.[2021]

Continuous EEG monitoring in the neurological ICU significantly influences medical decision-making in over 75% of patients, highlighting its importance in patient management.

This monitoring technique can also detect non-convulsive seizures in about one-third of patients, which may otherwise go unnoticed, emphasizing its role in improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrophysiologic monitoring in the intensive care unit. Hill, RA., Chiappa, KH.[2015]

Conventional EEG is increasingly utilized in NICUs for monitoring neonatal brain health, particularly with the rise of therapeutic hypothermia and neurocritical care, allowing for better assessment of brain injury and seizure management.

Continuous EEG monitoring enhances the ability to evaluate injury severity, track treatment responses, and predict neurological outcomes, potentially advancing neuroprotection strategies in neonatal care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conventional (continuous) EEG monitoring in the NICU. Chang, T., Tsuchida, TN.[2019]

Continuous EEG monitoring in neuroscience ICUs can significantly influence medical decisions in 81% of patients, helping to detect reversible brain abnormalities and nonconvulsive seizures in 34% of monitored patients.

Technological advancements, particularly in real-time digitized EEG, have improved the application of EEG monitoring, making it a crucial tool for assessing cerebral function and prognosis in comatose patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous EEG and evoked potential monitoring in the neuroscience intensive care unit. Jordan, KG.[2022]

The BRM2 portable EEG monitor allows for bedside neurological monitoring in neonatal intensive care units, making it easier for nurses to apply electrodes and interpret data using a user-friendly touchscreen interface.

This low-cost device enhances access to neurological monitoring, potentially improving the diagnosis and prognosis of neurological conditions in newborns by enabling remote expert review of digital records.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term EEG monitoring in the Neonatal Intensive Care Unit. Macdonald, G.[2020]

The SedLine brain monitor can effectively differentiate sleep stages and capture arousals in critically ill patients, showing a moderate agreement with traditional polysomnography (PSG) in a pilot study involving 23 ICU patients.

Despite the ability to monitor sleep stages, the study found that critically ill patients experienced fragmented sleep with significantly reduced REM and deep sleep (N3), but this sleep disruption did not correlate with an increased occurrence of ICU delirium.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Feasibility and Utility of Continuous Sleep Monitoring in Critically Ill Patients Using a Portable Electroencephalography Monitor. Vacas, S., McInrue, E., Gropper, MA., et al.[2020]

In a study of 20 patients undergoing long-term video EEG monitoring for epilepsy, only 1 injury (0.6%) and 6 falls (3.5%) were reported, indicating that while falls and adverse events can occur, serious injuries are rare.

The study highlighted the need for standardized safety protocols in epilepsy monitoring units, as many seizures (40.6%) went without staff response, particularly those that were electrographic and not detected by monitoring systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving safety outcomes in the epilepsy monitoring unit. Atkinson, M., Hari, K., Schaefer, K., et al.[2022]

A new automated bedside monitoring system has been developed for continuous assessment of central nervous system function in neurological intensive care, capable of sampling various electrophysiological waveforms and vital parameters without supervision.

This system provides real-time data access for neurologists, potentially allowing for early detection of critical conditions like herniation, subclinical seizures, and ischemia, enhancing patient safety and care in intensive settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurointensive care unit system for continuous electrophysiological monitoring with remote web-based review. van der Kouwe, AJ., Burgess, RC.[2019]

In a study of 70 patients with traumatic brain injury (TBI), 33% developed seizures, typically occurring around 74 hours after the injury, highlighting the importance of continuous EEG monitoring in neurointensive care.

The study found that older patients and those with low-energy trauma were more likely to experience seizures, while other EEG patterns, such as focal high frequency activity and paroxysmal delta activity, were also observed, indicating a need for further research into posttraumatic brain activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous EEG monitoring in patients with traumatic brain injury reveals a high incidence of epileptiform activity. Ronne-Engstrom, E., Winkler, T.[2006]

Citations

1. mountsinai.org mountsinai.org/clinical-trials/neurosteer-bedside-monitoring-system

Neurosteer Bedside Monitoring System The purpose of this study is to evaluate the clinical utility of Neurosteer's brain monitoring platform for monitoring delirium, sedation, and agitation in ...

2. neurosteer.com neurosteer.com/

Neurosteer - Advancing the Century-Old EEG into the 21st ... Neurosteer's hdrEEG uses an adhesive forehead strip connected to a pocket-sized sensor that wirelessly transmits data to the cloud for signal processing.

3. neurosteer.com neurosteer.com/solutions

Solutions Neurosteer's unobtrusive single-channel EEG platform can revolutionize the standard of care for ICU bedside brain monitoring. ... individual effectiveness.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05524415

Evaluation of Neurosteer System in Stroke Patients Neurosteer system (single channel EEG recording during cognitive auditory tasks). Using data analysis (a variant of the wavelet packet analysis and the best ...

5. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf22/K221563.pdf

October 24, 2022 Neurosteer Inc. Janice Hogan Partner ... The Neurosteer brain monitoring platform is a portable single channel EEG that measures and records electrical activity of the brain. An ...

6. neurosteer.com neurosteer.com/news/221103-fda-clearance-announcement

Neurosteer Announces FDA Clearance of the ... Neurosteer Inc. today announced the FDA clearance of its Neurosteer® single-channel EEG brain monitoring platform.