Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:33 AM
Study NCT ID:
NCT04386902
Status:
COMPLETED
Last Update Posted:
2021-04-08
First Post:
2020-05-03
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Evaluation of Cognitive State Using Neurosteer EEG System
Sponsor:
Neurosteer Ltd.
Organization:
Study Overview
Official Title:
Evaluation of Cognitive State Using Neurosteer EEG System in Patients Suffering From Cognitive Decline
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed 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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: