Evaluation of Cognitive State in Seniors Using Neurosteer EEG System

Neurosteer

Status

Completed

Conditions

Cognitive Decline

Treatments

Device: Neurosteer EEG recorder

Study type

Observational

Funder types

Industry

Identifiers

NCT05528445

032022

Details and patient eligibility

About

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.

Full 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. Therefore, the development of a reliable tool to assess brain neurodegeneration, associated with cognitive decline independent of personal interpretation and/or variance between clinicians and between medical facilities would be highly valuable. This tool would allow the healthcare team to make appropriate treatment decisions that could aid in neurodegenerative disease prevention.

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. Research staff will inform the patient on study's objective and design. Patients will sign the Informed Consent Form (ICF). Research staff will set up an assessment session using the Neurosteer system. In this session the patient will listen to the auditory assessment battery and perform cognitive tasks. Over the next 7 days, clinical staff will set up another session using the Neurosteer system. In this session the patient will listen to auditory instructions and perform two PASS sub-tasks: a drug sorting task and a phone use task.

Level of cognition will be assessed by validated screening tools (MMSE and MoCA) and the Neurosteer technology.

Enrollment

77 patients

Sex

All

Ages

50+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

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.
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.