Evaluation of Cognitive State in Seniors Using Neurosteer EEG System

Study Overview
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Brief Summary
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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
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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. Therefore, the development of a reliable tool to assess brain neurodegeneration, associated with cognitive decline independent of personal interpretation and/or variance between clinicians and between medical facilities would be highly valuable. This tool would allow the healthcare team to make appropriate treatment decisions that could aid in neurodegenerative disease prevention. 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. Research staff will inform the patient on study's objective and design. Patients will sign the Informed Consent Form (ICF). Research staff will set up an assessment session using the Neurosteer system. In this session the patient will listen to the auditory assessment battery and perform cognitive tasks. Over the next 7 days, clinical staff will set up another session using the Neurosteer system. In this session the patient will listen to auditory instructions and perform two PASS sub-tasks: a drug sorting task and a phone use task. Level of cognition will be assessed by validated screening tools (MMSE and MoCA) and the Neurosteer technology.

Official Title
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Evaluation of Cognitive State in Seniors Using Neurosteer Single-channel EEG With an Auditory Assessment Tool

Conditions
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Cognitive Decline

Intervention / Treatment
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* Device: Neurosteer EEG recorder


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women over the age of 50. MMSE ≥ 10 Patient is able to collaborate. No seizure events. 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. Significant hearing impairments. Significant vision impairments. Damage to integrity of scalp and/or skull. Skin irritation in the facial and forehead area. Epilepsy or seizure activity. History of drug abuse.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>Patients who are assessed by the clinical staff using Mini-Mental State Exam (MMSE) and Montreal-Cognitive-Assessment-Test(MoCA) | Device: Neurosteer EEG recorder<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation Between Cognition Level Changes as Evaluated by Current Clinical Tools (i.e. MMSE, MoCA) and Brain Activity Features Extracted Using the Neurosteer Technology. | Cognition level changes will be evaluated by: Mini Mental State Examination (MMSE). A commonly used assessment tool that evaluates cognitive functioning and produces a total possible score of 30 points. Patients who score below 24 are typically suspected of cognitive decline. Montreal Cognitive Assessment (MoCA). A commonly used assessment tool that evaluates cognitive functioning. The maximum score is 30, with a score of 26 or higher considered cognitively healthy. 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 MMSE and MoCA scores. | MMSE and MoCA scores will be taken from previous evaluation performed in the institute. Through study completion, brain activity features will be assessed twice within 7 days using the Neurosteer EEG system. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reproducibility of the Pilot Study Results | In a previous pilot study on a similar population of 50 subjects, biomarkers A0 and ST4 were found to be significantly correlated with MMSE scores. To validate this result, Intra class correlation coefficient (ICC) score will be calculated between the results in the first and second study. | 1 year | 
| Differentiation Between Subjects Who Are at Risk for Cognitive Decline and Cognitively Healthy Subjects. | In the pilot study, biomarkers A0 and ST4 showed significant ability to differentiate between the group of seniors with cognitive decline (MMSE scores 24-27) and the group of cognitively healthy seniors (MMSE scores 28-30). To reproduce this result, ANOVA will be calculated to determine if there are significant changes between group MMSE scores 24-27 and group MMSE score 28-30, p value<0.05 will be considered significant. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognition, Neurology, EEG, Neurosteer