Evaluation of Cognitive State in Seniors Using Neurosteer EEG System

NCT05528445 | Completed Results

• 1 other identifier: 032022
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Decline

Keywords

Cognition; Neurology; EEG; Neurosteer

Outcome Measures

Primary Outcomes (1)

• 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: 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.

  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.

Study Arms (1)

Patients

Patients who are assessed by the clinical staff using Mini-Mental State Exam (MMSE) and Montreal-Cognitive-Assessment-Test(MoCA)

Device: Neurosteer EEG recorder

Interventions

Neurosteer EEG recorder DEVICE

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.

Patients

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population is comprised of patients from the inpatient rehabilitation department at Dorot Geriatric Medical Center.

You may qualify if:

• Men and women over the age of 50.
• MMSE ≥ 10
• Patient is able to collaborate.
• No seizure events.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neurosteer Ltd.: lead

Study Sites (1)

Dorot - Netanya Geriatric Medical Center

Netanya, 42420, Israel

Location

Related Publications (3)

• Molcho L, Maimon NB, Regev-Plotnik N, Rabinowicz S, Intrator N, Sasson A. Single-Channel EEG Features Reveal an Association With Cognitive Decline in Seniors Performing Auditory Cognitive Assessment. Front Aging Neurosci. 2022 May 30;14:773692. doi: 10.3389/fnagi.2022.773692. eCollection 2022.

  PMID: 35707705 BACKGROUND

• Maimon NB, Bez M, Drobot D, Molcho L, Intrator N, Kakiashvilli E, Bickel A. Continuous Monitoring of Mental Load During Virtual Simulator Training for Laparoscopic Surgery Reflects Laparoscopic Dexterity: A Comparative Study Using a Novel Wireless Device. Front Neurosci. 2022 Jan 20;15:694010. doi: 10.3389/fnins.2021.694010. eCollection 2021.

  PMID: 35126032 BACKGROUND

• Curcic J, Vallejo V, Sorinas J, Sverdlov O, Praestgaard J, Piksa M, Deurinck M, Erdemli G, Bugler M, Tarnanas I, Taptiklis N, Cormack F, Anker R, Masse F, Souillard-Mandar W, Intrator N, Molcho L, Madero E, Bott N, Chambers M, Tamory J, Shulz M, Fernandez G, Simpson W, Robin J, Snaedal JG, Cha JH, Hannesdottir K. Description of the Method for Evaluating Digital Endpoints in Alzheimer Disease Study: Protocol for an Exploratory, Cross-sectional Study. JMIR Res Protoc. 2022 Aug 10;11(8):e35442. doi: 10.2196/35442.

  PMID: 35947423 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Nathan Intrator, Prof.
• Organization: Neurosteer

nathan@neurosteer.com

+1 (401) 837-0351

Study Officials

• Ady Sasson

  Dorot, Geriatric Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: September 6, 2022
• Study Start: May 31, 2022
• Primary Completion: August 27, 2023
• Study Completion: August 27, 2023
• Last Updated: May 6, 2024
• Results First Posted: May 6, 2024

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)