Neurosteer Bedside Monitoring System

NCT06718764 | Recruiting FDA Device

• 1 other identifier: STUDY-23-00018
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Delirium; Sedation; Agitation

Outcome Measures

Primary Outcomes (1)

• Sedation as measured by Richmond Agitation Sedation Scale

  Richmond Agitation Sedation Scale (RASS) for measuring the depth of sedation in sedated, intubated critically ill patients. RASS scoring -5 to +4, is a valid and reliable instrument to assess level of sedation and agitated behavior during sedation, where higher scores indicate higher levels of agitation. 4 Combative, violent, danger to staff 3 Pulls or removes tube(s) or catheters; aggressive 2 Frequent non-purposeful movement 1 Anxious, apprehensive, but not aggressive 0 Alert and calm 1. Awakens to voice (eye opening/contact) \>10 sec 2. Light sedation, briefly awakens to voice (eye opening/contact) \<10 sec 3. Moderate sedation, movement or eye opening. No eye contact 4. Deep sedation, no response to voice, but movement or eye opening to physical stimulation 5. Unarousable, no response to voice or physical stimulation

  3-4 times daily throughout participants NSICU stay (average 14 days)

Secondary Outcomes (1)

• Delirium as measured by Confusion Assessment Method (CAM)

  1-2 times daily throughout participants NSICU stay (average 14 days)

Study Arms (2)

NSICU Patients with Acute Neurological Injuries (ANI)

ACTIVE COMPARATOR

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.

Device: Neurosteer's single-channel EEG monitoring device

NSICU Patients without Acute Neurological Injuries (ANI)

ACTIVE COMPARATOR

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.

Device: Neurosteer's single-channel EEG monitoring device

Interventions

Neurosteer's single-channel EEG monitoring device DEVICE

Neurosteer device will be attached to participants forehead and readings will be collected for the duration of their NSICU stay. 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.

NSICU Patients with Acute Neurological Injuries (ANI); NSICU Patients without Acute Neurological Injuries (ANI)

Eligibility Criteria

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

You may qualify if:

• 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
• Any assigned sex at birth, including individuals who are transgender or intersex
• Age 18 years or older
• Mechanically ventilated patients with an anticipated LOS \>/=48 hours on any sedative drips including propofol, midazolam, dexmedetomidine, fentanyl, dialudid, ketamine

You may not qualify if:

• Has known hearing problems and usage of hearing aids
• Has a rash on forehead
• History of polysubstance abuse
• Severe dementia
• Anticipated Withdrawing Life-Sustaining Therapy (WLST) within the next 24-48 hours

Sponsors & Collaborators

• Neurosteer Ltd.: collaborator
• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai Hospital

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Delirium; Psychomotor Agitation

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Dyskinesias; Psychomotor Disorders; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Study Officials

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

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leslie Melo, MPH

CONTACT

212-241-3376; leslie.melo@mountsinai.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: December 5, 2024
• Study Start: July 8, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 4, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)