Cognitive DeclineNCT04386902

Evaluation of Cognitive State Using Neurosteer EEG System

An observational study of Cognitive Decline, run by Neurosteer Ltd. at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 45 years and olderHealthy volunteers can take part
Conditions the study is for: Cognitive Decline
What is being tested?: Neurosteer Aurora system
Type of treatment: Medical device
How many people: 60 participants
Where: 1 siteIsrael
Study dates: 19 Sep 2019to 9 Jul 2020
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: The study population is comprised of patients from the inpatient rehabilitation department at Dorot Geriatric Medical Center were recruited to this study.

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Israel1 site

Dorot - Netanya Geriatric Medical Center
Netanya, 42420

Other trials in Israel

About this study

Official title: Evaluation of Cognitive State Using Neurosteer EEG System in Patients Suffering From Cognitive Decline

Read the 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.

Conditions: Cognitive Decline
Being tested: Neurosteer Aurora system
Keywords: Cognition, Neurology, EEG, Neurosteer
Medical subject headings: Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Neurosteer Aurora systemDevice
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.

Study groups in NCT04386902
Study group	Role	What they receive
Patients		Patients who are assessed by the clinical staff using Mini-Mental State Exam (MMSE) Receives: Device: Neurosteer Aurora system

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
Assessment will be conducted by questioning the subject after the test regarding tolerability to remain with the test equipment for the duration of the test and his ability to respond during the test.
Measured: 11 months
Overall Brain Activity in Patients
Brain activity will be measured by the EEG test. Results will be included in statistical analysis that will take into consideration the brain activity as shown in the entire testing period, using power in the known frequency bands (Alpha - Theta).
Measured: 11 months
Overall Response to Auditory Stimulation
Brain activity will be measured by the EEG test, and behavioral results will be measured as well using a clicker. Results will be included in statistical analysis that will take into consideration the brain activity using power in the known frequency bands (Alpha - Theta) as well as subject responses to the auditory stimulation as shown in the entire testing period, using known parameters such as reaction times, accuracy and hit rate.
Measured: 11 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Sep 20199 Jul 2020

First posted13 May 2020
Study start19 Sep 2019
Primary completion9 Jul 2020
Study completion9 Jul 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Cognitive DeclineStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04386902
Sponsor's protocol ID: 042019
Status last verified: Mar 2021
First submitted: 3 May 2020
Last updated: 8 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 1202204
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.
PubMed 19382130
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.
PubMed 24246494
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.
PubMed 27163677
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.
PubMed 30408596
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.
PubMed 30932053
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.
PubMed 35707705

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Cognitive Decline trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Cognitive State Using Neurosteer EEG System in Patients Suffering From Cognitive Decline
ClinicalTrials.gov ID: NCT04386902
Acronym / sponsor ID: 042019
Conditions: Cognitive Decline
Keywords: Cognition, Neurology, EEG, Neurosteer
Study type: Observational
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Neurosteer Ltd.Industry (pharma, biotech, devices)
Study start: 19 Sep 2019 (actual)
Primary completion: 9 Jul 2020 (actual)
Study completion: 9 Jul 2020 (actual)
First posted: 13 May 2020 (actual)
Results: Posted 12 Mar 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Patients	–	Device: Neurosteer Aurora systemPatients who are assessed by the clinical staff using Mini-Mental State Exam (MMSE)

Who may qualify

Ages: 45 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: The study population is comprised of patients from the inpatient rehabilitation department at Dorot Geriatric Medical Center were recruited to this study.

Key inclusion criteria (6 listed)

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

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Neurosteer Aurora systemThe 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.	Device	Patients

Primary outcome

Correlation Between Cognition Level Changes as Evaluated by Current Clinical Tools (i.e. MMSE) and Brain Activity Features Extracted Using the Neurosteer Technology.
Time frame: 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.
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.

3 secondary outcomes

Usability and Tolerability of the Neurosteer System in the Elderly Population
Time frame: 11 months
Overall Brain Activity in Patients
Time frame: 11 months
Overall Response to Auditory Stimulation
Time frame: 11 months

Results and safety

Results posted to the registry on 12 Mar 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients	60	50

Primary outcome: Correlation Between Cognition Level Changes as Evaluated by Current Clinical Tools (i.e. MMSE) and Brain Activity Features Extracted Using the Neurosteer Technology.

Time frame: 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.. Number. Unit: Pearson correlation coefficient

Measure	Patients n = 50
A0: Pearson r score	-0.3570
ST4: Pearson r score	0.3617

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Through study completion, in an average of twice a week during EEG recordings.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients	0 of 60 (0%)	0 of 60 (0%)	0 of 60

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 1202204Folstein 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.
Background: PubMed 19382130Guerrero-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.
Background: PubMed 24246494Meir-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.
Background: PubMed 27163677Meir-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.
Background: PubMed 30408596Goldway 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.
Background: PubMed 30932053Keynan 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.
Derived from this study: PubMed 35707705Molcho 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ady Sasson, Dr. principal investigator

Dorot, Geriatric Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Cognitive Decline, run by Neurosteer Ltd. at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correlation Between Cognition Level Changes as Evaluated by Current Clinical Tools (i.e. MMSE) and Brain Activity Features Extracted Using the Neurosteer Technology. (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04386902, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.