Evaluation of Cognitive State Using Neurosteer EEG System

  • STATUS
    Recruiting
  • participants needed
    60
  • sponsor
    Neurosteer Ltd.
Updated on 19 February 2024
mini-mental state examination
cognitive assessment
seizure

Summary

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 EEG recordings while listening to an auditory cognitive assessment tool and preforming tasks. EEG recordings will be analyzed using proprietary computational analyses.

Description

One of the major problems in the prevention and treatment of neurological disorders, is the lack of cost effective and reliable tools to assess neurodegeneration on a large scale at a very early stage. Although current imaging methods give a clear image of the brain atrophy involved in neurodegenerative disorders, there are deficiencies prohibiting their usage for prevention-scanning of large high-risk population such as high price, long set-up time and the need for trained personnel to conduct the test. An objective tool to asses the level of cognitive decline is therefore needed. Such a tool may be used to determine the level of cognitive decline 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, clinical staff will identify potential subjects and will examine the eligibility of subject according to inclusion and exclusion criteria. Patients (or legal guardian) will sign the Informed Consent Form (ICF). Research staff will set up an assessment session using Neurosteer system. In this session the patient will listen to the auditory assessment battery and perform tasks. Level of cognition will be assessed by Neurosteer technology and statistical analysis will be performed to validate the results.

Details
Condition Cognitive Decline
Age 45-100 years
Treatment Neurosteer Aurora system
Clinical Study IdentifierNCT04386902
SponsorNeurosteer Ltd.
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

Men and women over the age of 45
MMSE score < 30\
MMSE score 10
Patient is able to collaborate
No other cognitive comorbidity
No seizure event

Exclusion Criteria

Advanced stage of cognitive decline (MMSE < 10)
Any verbal or non-verbal form of objection from patient or form patient's family member or significant other
Presence of several cognitive comorbidity
Damage to integrity of scalp and/or skull
Skin irritation in the facial and forehead area
Significant hearing impairments
History of drug abuse
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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