Trial Outcomes & Findings for Evaluation of Cognitive State Using Neurosteer EEG System (NCT NCT04386902)

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

60 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 using the Neurosteer EEG system, in an average of twice a week.

Results posted on

2021-04-08

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	60
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Reasons for withdrawal
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 Withdrawal by Subject	5
Overall Study Technical problems in the recording	5

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients n=60 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=60 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=60 Participants
Age, Categorical >=65 years	57 Participants n=60 Participants
Age, Continuous	75.55 years STANDARD_DEVIATION 9.67 • n=60 Participants
Sex: Female, Male Female	32 Participants n=60 Participants
Sex: Female, Male Male	28 Participants n=60 Participants
Region of Enrollment Israel	60 participants n=60 Participants
MMSE score	25.06 units on a scale STANDARD_DEVIATION 3.65 • n=60 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 using the Neurosteer EEG system, in an average of twice a week.

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=50 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. A0: Pearson r score	-0.3570 Pearson correlation coefficient
Correlation Between Cognition Level Changes as Evaluated by Current Clinical Tools (i.e. MMSE) and Brain Activity Features Extracted Using the Neurosteer Technology. ST4: Pearson r score	0.3617 Pearson correlation coefficient

SECONDARY outcome

Timeframe: 11 months

Assessment will be conducted by questioning the subject after the test regarding tolerability to remain with the test equipment for the duration of the test and his ability to respond during the test.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 11 months

Brain activity will be measured by the EEG test. Results will be included in statistical analysis that will take into consideration the brain activity as shown in the entire testing period, using power in the known frequency bands (Alpha - Theta).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 11 months

Brain activity will be measured by the EEG test, and behavioral results will be measured as well using a clicker. Results will be included in statistical analysis that will take into consideration the brain activity using power in the known frequency bands (Alpha - Theta) as well as subject responses to the auditory stimulation as shown in the entire testing period, using known parameters such as reaction times, accuracy and hit rate.

Outcome measures

Outcome data not reported

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