Clinical trial NCT04386902: Evaluation of Cognitive State Using Neurosteer EEG System
Official title: Evaluation of Cognitive State Using Neurosteer EEG System in Patients Suffering From Cognitive Decline
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Decline
Keywords: Cognition
Neurology
EEG
Neurosteer
Lead sponsor: Neurosteer Ltd.
Sponsor class: INDUSTRY
First posted: 2020-05-13
Enrollment: 60
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Detailed description: One of the major problems in the prevention and treatment of neurological disorders, is the lack of cost effective and reliable tools to assess neurodegeneration on a large scale at a very early stage. Although current imaging methods give a clear image of the brain atrophy involved in neurodegenerative disorders, there are deficiencies prohibiting their usage for prevention-scanning of large high-risk population such as high price, long set-up time and the need for trained personnel to conduct the test. An objective tool to asses the level of cognitive decline is therefore needed. Such a tool may be used to determine the level of cognitive decline independent of personal interpretation and/or variance between clinicians and provide consistency in assessment across patients and between medical facilities.

The Neurosteer system provides objective neurological biomarkers using a wearable easy-to-use affordable system. The system facilitate the capture and interpretation of EEG data with only a single patch of electrodes, attached on the subject's forehead. Neurosteer examination includes completing auditory tasks while measuring brain activity with the device. The data is analyzed using machine learning methods to produce biomarkers, enabling a report of the patient's activity in real time and offline. The examination is easy to preform and can be conducted in every clinic or in patients' homes.

In this study, clinical staff will identify potential subjects and will examine the eligibility of subject according to inclusion and exclusion criteria. Patients (or legal guardian) will sign the Informed Consent Form (ICF). Research staff will set up an assessment session using Neurosteer system. In this session the patient will listen to the auditory assessment battery and perform tasks. Level of cognition will be assessed by Neurosteer technology and statistical analysis will be performed to validate the results.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Correlation Between Cognition Level Changes as Evaluated by Current Clinical Tools (i.e. MMSE) and Brain Activity Features Extracted Using the Neurosteer Technology.
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.
Secondary outcomes:
measure: Usability and Tolerability of the Neurosteer System in the Elderly Population
timeFrame: 11 months
measure: Overall Brain Activity in Patients
timeFrame: 11 months
measure: Overall Response to Auditory Stimulation
timeFrame: 11 months
Other outcomes:
Locations:
city: Netanya
country: Israel
facility: Dorot - Netanya Geriatric Medical Center
Study officials:
affiliation: Dorot, Geriatric Medical Center
name: Ady Sasson, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.