Acute StrokeNCT05524415
Evaluation of Neurosteer System in Stroke Patients
An observational study of Acute Stroke, 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 a series of EEG recordings during their hospitalization. EEG recordings will be analyzed using proprietary computational analyses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Stroke
- What is being tested?
- Neurosteer EEG recorder
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2023to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population is comprised of patients who are hospitalized in Soroka University Medical Center (SUMC) Neurology department with a diagnosis of acute stroke.
Who may be able to join
- Men and women over the age of 18.
- Hospitalized in Soroka University Medical Center (SUMC) Neurology department with a diagnosis of Stroke.
- NIHSS score ≥6.
Who cannot join
- Damage to integrity of scalp and/or skull.
- Any verbal or non-verbal form of objection from patient.
- Any verbal or non-verbal form of objection from patient's family member or significant other.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Neurosteer System (Quantitative EEG Features) in Stroke Patients Suffering From Disorders of Consciousness
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 a series of EEG recordings during their hospitalization. EEG recordings will be analyzed using proprietary computational analyses.
Read the detailed description
The abnormal state of consciousness is difficult to define, measure and characterize. Many of the terms mean different things to different people, and may prove inaccurate when transmitting and recording information regarding the state of consciousness of a patient. Modern clinical assessments of level of consciousness such as the Glasgow Coma Scale (GCS) or the Grady Coma Scale, in addition to being subjective assessments, are incomplete and insufficient as they are based on assessment of responsiveness only.
An objective tool to asses a level of consciousness is therefore needed. Such a tool may be used to determine the level of consciousness 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, research clinical staff (RCS) will identify potential subjects after being hospitalized in the department and will examine the eligibility of subject according to inclusion and exclusion criteria.
When a legal guardian is assigned, guardian will sign the Informed Consent Form (ICF). Otherwise, RCS will approach an independent physician who will be informed about the study and its goals. Independent physician will evaluate patient's eligibility for study. RCS will also inform patient's family/accompanying individuals on study's objective and design.
RCS will set up sanitized Neurosteer equipment at the patient's bed-side and record 72 consecutive hours of resting-state EEG. Level of consciousness will be assessed every 4 hours by the trained research personnel. Every 4 hours an auditory stimulation of 12 minutes will be played to the subject to assist in delirium assessment.
Level of consciousness will be assessed by validated screening tools (GCS) and the Neurosteer technology.
- Conditions
- Acute Stroke
- Being tested
- Neurosteer EEG recorder
- Keywords
- Cognition, Neurology, EEG, Neurosteer, Consciousness
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurosteer EEG recorderDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients who are hospitalized in Soroka University Medical Center (SUMC) Neurology department with a diagnosis of acute stroke Receives: Device: Neurosteer EEG recorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between consciousness level changes as evaluated by current clinical tools (i.e. GCS) and Brain Activity Features extracted using the Neurosteer technology.
Consciousness level changes will be evaluated by:
- Glasgow Coma Scale (GCS). A commonly used assessment tool that evaluates level of consciousness following a traumatic brain injury. The GCS score can range from 3 (completely unresponsive) to 15 (responsive). Generally, the brain injury is classified as: Severe, < 8-9, Moderate, 9-12 and Mild, ≥ 13.
- 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 GCS scores.
Measured: Level of consciousness will be assessed every 4 hours, up to 3 days (72 hours) after joining the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start1 Jan 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Why it stopped: No patients were recruited by the hospital staff
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute StrokeStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurosteer Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gal Ifergan, Principal investigator, Soroka University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05524415
- Sponsor's protocol ID
- SCRC18021
- Status last verified
- Mar 2024
- First submitted
- 29 Aug 2022
- Last updated
- 8 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 35707705Maimon NB, Bez M, Drobot D, Molcho L, Intrator N, Kakiashvilli E, Bickel A. Continuous Monitoring of Mental Load During Virtual Simulator Training for Laparoscopic Surgery Reflects Laparoscopic Dexterity: A Comparative Study Using a Novel Wireless Device. Front Neurosci. 2022 Jan 20;15:694010. doi: 10.3389/fnins.2021.694010. eCollection 2021.
PubMed 35126032Curcic J, Vallejo V, Sorinas J, Sverdlov O, Praestgaard J, Piksa M, Deurinck M, Erdemli G, Bugler M, Tarnanas I, Taptiklis N, Cormack F, Anker R, Masse F, Souillard-Mandar W, Intrator N, Molcho L, Madero E, Bott N, Chambers M, Tamory J, Shulz M, Fernandez G, Simpson W, Robin J, Snaedal JG, Cha JH, Hannesdottir K. Description of the Method for Evaluating Digital Endpoints in Alzheimer Disease Study: Protocol for an Exploratory, Cross-sectional Study. JMIR Res Protoc. 2022 Aug 10;11(8):e35442. doi: 10.2196/35442.
PubMed 35947423
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Neurosteer System (Quantitative EEG Features) in Stroke Patients Suffering From Disorders of Consciousness
- ClinicalTrials.gov ID
- NCT05524415
- Acronym / sponsor ID
- SCRC18021
- Conditions
- Acute Stroke
- Keywords
- Cognition, Neurology, EEG, Neurosteer, Consciousness
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No patients were recruited by the hospital staff
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Neurosteer Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 1 Sep 2022 (actual)
- Results
- Not posted in the source record
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 a series of EEG recordings during their hospitalization. EEG recordings will be analyzed using proprietary computational analyses.
Detailed description
The abnormal state of consciousness is difficult to define, measure and characterize. Many of the terms mean different things to different people, and may prove inaccurate when transmitting and recording information regarding the state of consciousness of a patient. Modern clinical assessments of level of consciousness such as the Glasgow Coma Scale (GCS) or the Grady Coma Scale, in addition to being subjective assessments, are incomplete and insufficient as they are based on assessment of responsiveness only.
An objective tool to asses a level of consciousness is therefore needed. Such a tool may be used to determine the level of consciousness 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, research clinical staff (RCS) will identify potential subjects after being hospitalized in the department and will examine the eligibility of subject according to inclusion and exclusion criteria.
When a legal guardian is assigned, guardian will sign the Informed Consent Form (ICF). Otherwise, RCS will approach an independent physician who will be informed about the study and its goals. Independent physician will evaluate patient's eligibility for study. RCS will also inform patient's family/accompanying individuals on study's objective and design.
RCS will set up sanitized Neurosteer equipment at the patient's bed-side and record 72 consecutive hours of resting-state EEG. Level of consciousness will be assessed every 4 hours by the trained research personnel. Every 4 hours an auditory stimulation of 12 minutes will be played to the subject to assist in delirium assessment.
Level of consciousness will be assessed by validated screening tools (GCS) and the Neurosteer technology.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Device: Neurosteer EEG recorderPatients who are hospitalized in Soroka University Medical Center (SUMC) Neurology department with a diagnosis of acute stroke |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is comprised of patients who are hospitalized in Soroka University Medical Center (SUMC) Neurology department with a diagnosis of acute stroke.
Key inclusion criteria (3 listed)
- Men and women over the age of 18.
- Hospitalized in Soroka University Medical Center (SUMC) Neurology department with a diagnosis of Stroke.
- NIHSS score ≥6.
Key exclusion criteria (3 listed)
- Damage to integrity of scalp and/or skull.
- Any verbal or non-verbal form of objection from patient.
- Any verbal or non-verbal form of objection from patient's family member or significant other.
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 EEG recorderThe 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. | Device | Patients |
Primary outcome
Correlation between consciousness level changes as evaluated by current clinical tools (i.e. GCS) and Brain Activity Features extracted using the Neurosteer technology.
Time frame: Level of consciousness will be assessed every 4 hours, up to 3 days (72 hours) after joining the study.
Consciousness level changes will be evaluated by: 1. Glasgow Coma Scale (GCS). A commonly used assessment tool that evaluates level of consciousness following a traumatic brain injury. The GCS score can range from 3 (completely unresponsive) to 15 (responsive). Generally, the brain injury is classified as: Severe, < 8-9, Moderate, 9-12 and Mild, ≥ 13. 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 GCS scores.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Background: 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.
- Background: PubMed 35126032Maimon NB, Bez M, Drobot D, Molcho L, Intrator N, Kakiashvilli E, Bickel A. Continuous Monitoring of Mental Load During Virtual Simulator Training for Laparoscopic Surgery Reflects Laparoscopic Dexterity: A Comparative Study Using a Novel Wireless Device. Front Neurosci. 2022 Jan 20;15:694010. doi: 10.3389/fnins.2021.694010. eCollection 2021.
- Background: PubMed 35947423Curcic J, Vallejo V, Sorinas J, Sverdlov O, Praestgaard J, Piksa M, Deurinck M, Erdemli G, Bugler M, Tarnanas I, Taptiklis N, Cormack F, Anker R, Masse F, Souillard-Mandar W, Intrator N, Molcho L, Madero E, Bott N, Chambers M, Tamory J, Shulz M, Fernandez G, Simpson W, Robin J, Snaedal JG, Cha JH, Hannesdottir K. Description of the Method for Evaluating Digital Endpoints in Alzheimer Disease Study: Protocol for an Exploratory, Cross-sectional Study. JMIR Res Protoc. 2022 Aug 10;11(8):e35442. doi: 10.2196/35442.
- 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.
Gal Ifergan principal investigator
Soroka University 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 Acute Stroke, 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 3 inclusion and 3 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: withdrawn, as of the sponsor's last update on 8 Mar 2024. 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?
The study was withdrawn before enrolling participants, so there are no results.
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 consciousness level changes as evaluated by current clinical tools (i.e. GCS) and Brain Activity Features extracted using the Neurosteer technology. (time frame: Level of consciousness will be assessed every 4 hours, up to 3 days (72 hours) after joining the study.). 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 NCT05524415, which also lists 3 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 Mar 2024.