Mild Cognitive ImpairmentNCT04683835
Evaluation of Cognitive State in Senior Subjects Using Neurosteer EEG System
An observational study of Mild Cognitive Impairment, run by Neurosteer Ltd. at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Neurosteer Aurora system
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- 15 Oct 2020to 1 Oct 2021
- 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 50 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.
Who may be able to join
- Men and women over the age of 50.
- MMSE ≥ 24.
- Patient is able to collaborate.
- No other cognitive comorbidity.
- No seizure events.
Who cannot join
- MMSE < 24.
- 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.
About this study
Official title: Evaluation of Cognitive State in Senior Subjects Using Neurosteer Single-channel EEG With an Interactive Assessment Tool
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. EEG recordings will be analyzed using proprietary computational analyses.
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. 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 initial session using the Neurosteer system. In this session the patient will perform auditory cognitive assessment tasks. The patient will be re-examined in the same experimental setting over the next 7 days and at least 1 day later. Level of cognition will be assessed by the Neurosteer technology.
- Conditions
- Mild Cognitive Impairment
- 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 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:
- 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.
- 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 twice within 7 days using the Neurosteer EEG system.
Secondary outcomes (1)
Inter-patient Variability Between Two Consecutive Measurement Sessions.
One limitation in the pilot study was high variability among subjects. Therefore, the aim of this study is to evaluate within-patient variability. For this purpose, subjects in this study will undergo two consecutive assessments over a period of one week.
The within-patient variability will be evaluated by calculating the Pearson correlation between the mean activity of the EEG features in the first assessment session and the mean activity of the EEG features in the second assessment session.
Measured: Through study completion, the brain activity features of each subject will be assessed twice within 7 days, using the Neurosteer EEG system.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start15 Oct 2020
- Primary completion1 Aug 2021
- Study completion1 Oct 2021
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 (6)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurosteer Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ady Sasson, Dr., Principal investigator, Dorot, Geriatric Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04683835
- Sponsor's protocol ID
- 092020
- Status last verified
- Nov 2023
- First submitted
- 20 Dec 2020
- Last updated
- 13 Nov 2023
- 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 1202204Guerrero-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 19382130Meir-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 24246494Meir-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 27163677Goldway 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 30408596Keynan 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cognitive State in Senior Subjects Using Neurosteer Single-channel EEG With an Interactive Assessment Tool
- ClinicalTrials.gov ID
- NCT04683835
- Acronym / sponsor ID
- 092020
- Conditions
- Mild Cognitive Impairment
- Keywords
- Cognition, Neurology, EEG, Neurosteer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Neurosteer Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 24 Dec 2020 (actual)
- Results
- Posted 13 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. 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. 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 initial session using the Neurosteer system. In this session the patient will perform auditory cognitive assessment tasks. The patient will be re-examined in the same experimental setting over the next 7 days and at least 1 day later. Level of cognition will be assessed by the Neurosteer technology.
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
- 50 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.
Key inclusion criteria (5 listed)
- Men and women over the age of 50.
- MMSE ≥ 24.
- Patient is able to collaborate.
- No other cognitive comorbidity.
- No seizure events.
Key exclusion criteria (7 listed)
- MMSE < 24.
- 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 twice within 7 days using the Neurosteer EEG system.
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.
1 secondary outcome
Inter-patient Variability Between Two Consecutive Measurement Sessions.
Time frame: Through study completion, the brain activity features of each subject will be assessed twice within 7 days, using the Neurosteer EEG system.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- 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.
- 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 Mild Cognitive Impairment, 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 5 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 13 Nov 2023. 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 13 Nov 2023). 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 twice within 7 days using the Neurosteer EEG system.). 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 NCT04683835, which also lists 6 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 13 Nov 2023.