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

Trial Summary

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 data supports the effectiveness of the Neurosteer Bedside Monitoring System for ICU patients?

Research shows that continuous EEG monitoring, like the Neurosteer system, can detect seizure activity and other brain function abnormalities in ICU patients, which helps in making better medical decisions. Similar EEG systems have been effective in monitoring brain activity and predicting outcomes in various critical care settings. ^{1 2 3 4 5}

Is the Neurosteer Brain Monitoring Device safe for use in humans?

The research articles reviewed do not provide specific safety data for the Neurosteer Brain Monitoring Device or its variants. However, they discuss the use of EEG monitoring devices in intensive care settings, indicating that such devices are generally used safely for continuous brain monitoring in critically ill patients. ^{1 6 7 8 9}

How is the Neurosteer Bedside Monitoring System different from other treatments for ICU patients?

The Neurosteer Bedside Monitoring System is unique because it offers a single-channel EEG (electroencephalography) monitoring device that is portable and can be used at the bedside, making it more accessible and easier to use compared to traditional multi-channel EEG systems that require more complex setup and interpretation. ^{1 3 6 10 11}

What is the purpose of this trial?

The purpose of this study is to evaluate the clinical utility of Neurosteer's brain monitoring platform for monitoring delirium, sedation, and agitation in intubated and sedated ICU patients. The research team will be conducting a single-site study. The research team will enroll 100 patients admitted to the NSICU. 50 of these patients will have Acute Neurological Injuries (ANI) and the other 50 will not have an ANI. All enrolled patients will receive the intervention, the Neurosteer brain monitoring device. The study intervention consists of the use of Neurosteer's innovative single-channel EEG monitoring device to determine if there is a good correlation and agreement between their signals/parameters to RASS, CAM-ICU, and continuous EEG monitoring readings. The Neurosteer device will be attached to their forehead and readings will be collected for the duration of their NSICU stay. The research team will adapt the current physical methods of detecting the depth of anesthesia i.e. through the Richmond Agitation-Sedation Scale (RASS) \& CAM-ICU, to auditory stimulation, which will be delivered through earphones with no physical contact, with the aim of achieving a high correlation between the methods. RASS and CAM-ICU will be collected hourly as standard of care and Neurosteer auditory stimulation will be done 3-4 times a day to coincide with RASS and 1-2 times a day to coincide with CAM-ICU. The research team will correlate collected hourly RASS and CAM-ICU assessments with Neurosteer derived signals and parameters.

Research Team

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

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Evaluation of a new wireless technique for continuous electroencephalography monitoring in neurological intensive care patients. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

The Feasibility and Utility of Continuous Sleep Monitoring in Critically Ill Patients Using a Portable Electroencephalography Monitor. [2020]

3. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Conventional (continuous) EEG monitoring in the NICU. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

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

5. England pubmed.ncbi.nlm.nih.gov

Predicting functional outcomes after stroke: an observational study of acute single-channel EEG. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

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

7. Switzerland 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. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Improving safety outcomes in the epilepsy monitoring unit. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Neurointensive care unit system for continuous electrophysiological monitoring with remote web-based review. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Electrophysiologic monitoring in the intensive care unit. [2015]

11. Denmark pubmed.ncbi.nlm.nih.gov

Continuous EEG monitoring in patients with traumatic brain injury reveals a high incidence of epileptiform activity. [2006]