Evaluation of Cognitive State Using Neurosteer EEG System

NCT04386902 | Completed Results FDA Device

• 1 other identifier: 042019
• Study Type: observational
• Target: 60
• 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) 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. 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.

  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.

Secondary Outcomes (3)

• Usability and Tolerability of the Neurosteer System in the Elderly Population

  11 months

• Overall Brain Activity in Patients

  11 months

• Overall Response to Auditory Stimulation

  11 months

Study Arms (1)

Patients

Patients who are assessed by the clinical staff using Mini-Mental State Exam (MMSE)

Device: Neurosteer Aurora system

Interventions

Neurosteer Aurora system 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, which is accessible via any web interface.

Patients

Eligibility Criteria

• Age: 45 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 were recruited to this study.

You may qualify if:

• Men and women over the age of 45.
• MMSE score \< 30.
• MMSE score ≥ 10.
• Patient is able to collaborate.
• No other cognitive comorbidity.
• No seizure event.

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.
• Presence of several cognitive comorbidity.
• Damage to integrity of scalp and/or skull.
• Skin irritation in the facial and forehead area.
• Significant hearing impairments.
• History of drug abuse.

Sponsors & Collaborators

• Neurosteer Ltd.: lead

Study Sites (1)

Dorot - Netanya Geriatric Medical Center

Netanya, 42420, Israel

Location

Related Publications (7)

• Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.

  PMID: 1202204 BACKGROUND

• Guerrero-Berroa E, Luo X, Schmeidler J, Rapp MA, Dahlman K, Grossman HT, Haroutunian V, Beeri MS. The MMSE orientation for time domain is a strong predictor of subsequent cognitive decline in the elderly. Int J Geriatr Psychiatry. 2009 Dec;24(12):1429-37. doi: 10.1002/gps.2282.

  PMID: 19382130 BACKGROUND

• Meir-Hasson Y, Kinreich S, Podlipsky I, Hendler T, Intrator N. An EEG Finger-Print of fMRI deep regional activation. Neuroimage. 2014 Nov 15;102 Pt 1:128-41. doi: 10.1016/j.neuroimage.2013.11.004. Epub 2013 Nov 15.

  PMID: 24246494 BACKGROUND

• Meir-Hasson Y, Keynan JN, Kinreich S, Jackont G, Cohen A, Podlipsky-Klovatch I, Hendler T, Intrator N. One-Class FMRI-Inspired EEG Model for Self-Regulation Training. PLoS One. 2016 May 10;11(5):e0154968. doi: 10.1371/journal.pone.0154968. eCollection 2016.

  PMID: 27163677 BACKGROUND

• Goldway N, Ablin J, Lubin O, Zamir Y, Keynan JN, Or-Borichev A, Cavazza M, Charles F, Intrator N, Brill S, Ben-Simon E, Sharon H, Hendler T. Volitional limbic neuromodulation exerts a beneficial clinical effect on Fibromyalgia. Neuroimage. 2019 Feb 1;186:758-770. doi: 10.1016/j.neuroimage.2018.11.001. Epub 2018 Nov 5.

  PMID: 30408596 BACKGROUND

• Keynan JN, Cohen A, Jackont G, Green N, Goldway N, Davidov A, Meir-Hasson Y, Raz G, Intrator N, Fruchter E, Ginat K, Laska E, Cavazza M, Hendler T. Electrical fingerprint of the amygdala guides neurofeedback training for stress resilience. Nat Hum Behav. 2019 Jan;3(1):63-73. doi: 10.1038/s41562-018-0484-3. Epub 2018 Dec 10.

  PMID: 30932053 BACKGROUND

• 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 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Limitations and Caveats

Small cohorts of patients: future studies should consider larger cohorts. High variability among subjects: future studies should consider more testing periods to quantify the variability within subjects.

Results Point of Contact

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

nathan@neurosteer.com

+1 (401) 837-0351

Study Officials

• Ady Sasson, Dr.

  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: May 3, 2020
• First Posted: May 13, 2020
• Study Start: September 19, 2019
• Primary Completion: July 9, 2020
• Study Completion: July 9, 2020
• Last Updated: April 8, 2021
• Results First Posted: March 12, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)