Trial Outcomes & Findings for Evaluation of Cognitive State in Senior Subjects Using Neurosteer EEG System (NCT NCT04683835)

Results Overview

Cognition level changes will be evaluated by: 1. 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. 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 MMSE score.

Recruitment status

COMPLETED

Target enrollment

80 participants

Primary outcome timeframe

MMSE score 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.

Results posted on

2023-11-13

Participant Flow

Participant milestones

Participant milestones
Measure	Patients Patients who are assessed by the clinical staff using Mini-Mental State Exam (MMSE) Neurosteer Aurora system: 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, which is accessible via any web interface
Overall Study STARTED	80
Overall Study COMPLETED	80
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients n=80 Participants Patients who are assessed by the clinical staff using Mini-Mental State Exam (MMSE) Neurosteer Aurora system: 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, which is accessible via any web interface
Age, Categorical <=18 years	0 Participants n=80 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=80 Participants
Age, Categorical >=65 years	65 Participants n=80 Participants
Age, Continuous	73.86 years STANDARD_DEVIATION 10.33 • n=80 Participants
Sex: Female, Male Female	40 Participants n=80 Participants
Sex: Female, Male Male	40 Participants n=80 Participants
Region of Enrollment Israel	80 participants n=80 Participants
MMSE score	27.21 units on a scale STANDARD_DEVIATION 2.05 • n=80 Participants

PRIMARY outcome

Timeframe: MMSE score 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.

Cognition level changes will be evaluated by: 1. 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. 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 MMSE score.

Outcome measures

Outcome measures
Measure	Patients n=80 Participants Patients who are assessed by the clinical staff using Mini-Mental State Exam (MMSE) Neurosteer Aurora system: 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, which is accessible via any web interface
Correlation Between Cognition Level Changes as Evaluated by Current Clinical Tools (i.e. MMSE) and Brain Activity Features Extracted Using the Neurosteer Technology.	0.1486 Pearson correlation coefficient

SECONDARY outcome

Timeframe: Through study completion, the brain activity features of each subject will be assessed twice within 7 days, using the Neurosteer EEG system.

One limitation in the pilot study was high variability among subjects. Therefore, the aim of this study is to evaluate within-patient variability. For this purpose, subjects in this study will undergo two consecutive assessments over a period of one week. The within-patient variability will be evaluated by calculating the Pearson correlation between the mean activity of the EEG features in the first assessment session and the mean activity of the EEG features in the second assessment session.

Outcome measures

Outcome measures
Measure	Patients n=80 Participants Patients who are assessed by the clinical staff using Mini-Mental State Exam (MMSE) Neurosteer Aurora system: 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, which is accessible via any web interface
Inter-patient Variability Between Two Consecutive Measurement Sessions.	0.583 Pearson correlation coefficient

Adverse Events

Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nathan Intrator, Prof.

Neurosteer

Phone: +1 (401) 837-0351

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place