Trial Outcomes & Findings for Evaluation of Cognitive State in Seniors Using Neurosteer EEG System (NCT NCT05528445)

Last Updated: 2024-05-06

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. 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. 3. 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.

Recruitment status

COMPLETED

Target enrollment

77 participants

Primary outcome timeframe

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.

Results posted on

2024-05-06

Participant Flow

Participant milestones

Participant milestones
Measure	Patients Patients who are assessed by the clinical staff using Mini-Mental State Exam (MMSE) and Montreal-Cognitive-Assessment-Test(MoCA) Neurosteer EEG recorder: 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.
Overall Study STARTED	77
Overall Study COMPLETED	77
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=77 Participants Patients who are assessed by the clinical staff using Mini-Mental State Exam (MMSE) and Montreal-Cognitive-Assessment-Test (MoCA) Neurosteer EEG recorder: 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.
Age, Categorical <=18 years	0 Participants n=77 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=77 Participants
Age, Categorical >=65 years	67 Participants n=77 Participants
Age, Continuous	74.28 years STANDARD_DEVIATION 8.99 • n=77 Participants
Sex: Female, Male Female	40 Participants n=77 Participants
Sex: Female, Male Male	37 Participants n=77 Participants
Region of Enrollment Israel	77 participants n=77 Participants
MMSE score	26 units on a scale STANDARD_DEVIATION 4 • n=77 Participants
MoCA score	19.9 units on a scale STANDARD_DEVIATION 5 • n=58 Participants • The number of subjects with a MoCA score is different from the overall number of subjects because some of the subjects were released from the department before undergoing the assessment.

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Patients n=77 Participants Patients who are assessed by the clinical staff using Mini-Mental State Exam (MMSE) and Montreal-Cognitive-Assessment-Test(MoCA) Neurosteer EEG recorder: 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.
Correlation Between Cognition Level Changes as Evaluated by Current Clinical Tools (i.e. MMSE, MoCA) and Brain Activity Features Extracted Using the Neurosteer Technology. MMSE score + A0 activity	-0.27 Pearson correlation coefficient
Correlation Between Cognition Level Changes as Evaluated by Current Clinical Tools (i.e. MMSE, MoCA) and Brain Activity Features Extracted Using the Neurosteer Technology. MoCA score + A0 activity	-0.26 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