Evaluation of Neurosteer System in Stroke Patients

March 6, 2024 updated by: Neurosteer Ltd.

Evaluation of Neurosteer System (Quantitative EEG Features) in Stroke Patients Suffering From Disorders of Consciousness

This is an observational study. Patients who fulfill all inclusion criteria and none of the exclusion criteria will be enrolled in the study, be neurologically evaluated and will go through a series of EEG recordings during their hospitalization. EEG recordings will be analyzed using proprietary computational analyses.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

The abnormal state of consciousness is difficult to define, measure and characterize. Many of the terms mean different things to different people, and may prove inaccurate when transmitting and recording information regarding the state of consciousness of a patient. Modern clinical assessments of level of consciousness such as the Glasgow Coma Scale (GCS) or the Grady Coma Scale, in addition to being subjective assessments, are incomplete and insufficient as they are based on assessment of responsiveness only.

An objective tool to asses a level of consciousness is therefore needed. Such a tool may be used to determine the level of consciousness independent of personal interpretation and/or variance between clinicians and provide consistency in assessment across patients and between medical facilities.

The Neurosteer system provides objective neurological biomarkers using a wearable easy-to-use affordable system. The system facilitate the capture and interpretation of EEG data with only a single patch of electrodes, attached on the subject's forehead. Neurosteer examination includes completing auditory tasks while measuring brain activity with the device. The data is analyzed using machine learning methods to produce biomarkers, enabling a report of the patient's activity in real time and offline. The examination is easy to preform and can be conducted in every clinic or in patients' homes.

In this study, research clinical staff (RCS) will identify potential subjects after being hospitalized in the department and will examine the eligibility of subject according to inclusion and exclusion criteria.

When a legal guardian is assigned, guardian will sign the Informed Consent Form (ICF). Otherwise, RCS will approach an independent physician who will be informed about the study and its goals. Independent physician will evaluate patient's eligibility for study. RCS will also inform patient's family/accompanying individuals on study's objective and design.

RCS will set up sanitized Neurosteer equipment at the patient's bed-side and record 72 consecutive hours of resting-state EEG. Level of consciousness will be assessed every 4 hours by the trained research personnel. Every 4 hours an auditory stimulation of 12 minutes will be played to the subject to assist in delirium assessment.

Level of consciousness will be assessed by validated screening tools (GCS) and the Neurosteer technology.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Beer Sheva, Israel
        • Soroka university medical center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population is comprised of patients who are hospitalized in Soroka University Medical Center (SUMC) Neurology department with a diagnosis of acute stroke.

Description

Inclusion Criteria:

  • Men and women over the age of 18.
  • Hospitalized in Soroka University Medical Center (SUMC) Neurology department with a diagnosis of Stroke.
  • NIHSS score ≥6.

Exclusion Criteria:

  • Damage to integrity of scalp and/or skull.
  • Any verbal or non-verbal form of objection from patient.
  • Any verbal or non-verbal form of objection from patient's family member or significant other.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients
Patients who are hospitalized in Soroka University Medical Center (SUMC) Neurology department with a diagnosis of acute stroke
Device: Neurosteer EEG recorder
The system is composed of hardware and software modules that facilitate the capture and interpretation of electrophysiological data as well as enable viewing the processed data in real time and offline. An electrode patch is attached on the subject's forehead to capture the electrophysiological signal. The signal is sent via low energy Bluetooth to an EEG Monitor. The signal is then sent via Wi-Fi to the cloud where the data is stored on a HIPAA compliant server. Data analysis performed in the cloud transforms the electrophysiological signal into easily readable data of brain activity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between consciousness level changes as evaluated by current clinical tools (i.e. GCS) and Brain Activity Features extracted using the Neurosteer technology.
Time Frame: Level of consciousness will be assessed every 4 hours, up to 3 days (72 hours) after joining the study.

Consciousness level changes will be evaluated by:

  1. Glasgow Coma Scale (GCS). A commonly used assessment tool that evaluates level of consciousness following a traumatic brain injury. The GCS score can range from 3 (completely unresponsive) to 15 (responsive).

    Generally, the brain injury is classified as:

    Severe, < 8-9, Moderate, 9-12 and Mild, ≥ 13.

  2. Neurosteer system (single channel EEG recording during cognitive auditory tasks).

Using data analysis (a variant of the wavelet packet analysis and the best basis algorithm), the EEG signal is transformed into brain activity features (e.g. ST4, A0).

Pearson correlation will be calculated between the mean activity of the EEG features and individual's GCS scores.
Level of consciousness will be assessed every 4 hours, up to 3 days (72 hours) after joining the study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neurosteer Ltd.

Investigators

  • Principal Investigator: Gal Ifergan, Soroka university medical center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2023

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

August 29, 2022

First Submitted That Met QC Criteria

August 31, 2022

First Posted (Actual)

September 1, 2022

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCRC18021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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