Traumatic Brain Injury (TBI)TBINCT02878577
Monitoring the Alterations That Occur in the Brain Following Traumatic Brain Injury
An observational study of Traumatic Brain Injury (TBI), run by ElMindA Ltd at 1 site in Israel.
Trial summary
This project, will combine the data collected from existing and innovative technologies: fMRI scans, mapping brain connectivity using EEG in combination with eye-tracking technology (the BNA technology developed by ELMINDA), characterizing of cortical layers using magnetic resonance (the CoLI technology developed by… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury (TBI)
- What is being tested?
- fMRI
- Type of treatment
- Medical device
- How many people
- 68 participants
- Where
- 1 siteIsrael
- Study dates
- 21 Sep 2016to 18 Jul 2018
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: study population will include two groups of subjects: group 1: subjects after a traumatic brain injury group 2: control group
Who may be able to join
- Had the Glasgow coma scale score of 3-15 after the incident. (group 1)
- males and females Age: 18-60 (not during their military service).
Who cannot join
- History of neurological disorders, mental retardation or a previous head injury.
- Current diagnosis or history of psychiatric disorders.
- Drugs and / or alcohol dependence or abuse existed prior to the head injury.
- Unconsciousness.
- Pregnancy.
- Artificial respiration.
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- Renal failure.
- Cardiovascular instability.
- Metabolic instability (water, electrolytes, sugar).
- Fever or evidence of microbiological pollutant.
- Uncontrolled seizures.
- Hydrocephalus.
- Patients with open wounds that are not bandaged, preventing the use of the EEG cap.
- Deafness or blindness.
- History of drugs that affect the nervous system in the 3 months prior to the injury.
- Inability to cooperate in carrying out the necessary tests
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Monitoring Alterations Following Traumatic Brain Injury Using Clinical Evaluation, Neuropsychological Assessments, Structural and Functional MRI and EEG Analysis
This project, will combine the data collected from existing and innovative technologies: fMRI scans, mapping brain connectivity using EEG in combination with eye-tracking technology (the BNA technology developed by ELMINDA), characterizing of cortical layers using magnetic resonance (the CoLI technology developed by Tel-Aviv University), and DTI imaging (imaging of brain tracks). To do so, Sheba's Medical Center, Tel Hashomer, joined the project and is responsible for recruiting patients from the Department of Neurosurgery and Department of Rehabilitation and also is responsible for performing the needed tests.
Read the detailed description
This research project is the continuation of the NOFAR project, collaboration between ELMINDA and Tel-Aviv University, which included a proof of concept of the technology developed in the university to characterize cortical layers using magnetic resonance. In light of the promising results, the partners have decided to make another leap forward, and test the technology amongst specific patient population who suffered a brain trauma (traumatic brain injury, TBI).
Early and proper diagnosis of brain injury is critical, since it can prevent further complications to the patient's health. The tests that are currently available are limited in their ability to provide a comprehensive and accurate assessment of the injured brain: imaging exams such as CT, MRI and PET help identify the location and severity of the injury but cannot provide data on the cognitive and functional effects of the injury. On the other hand, neuropsychological tests only allow examination of current cognitive functioning, and cognitive decline quantification is done according to mathematical models and subjective assessments of the patient and his family. Therefore, this area is lacking and it is important to find an objective measure that enables quantification of brain injury that will be an indication of cognitive decline.
The current project, will last two years, and will combine the data collected from existing and innovative technologies: fMRI scans, mapping brain connectivity using EEG in combination with eye-tracking technology (the BNA technology developed by ELMINDA), characterizing of cortical layers using magnetic resonance (the CoLI technology developed by Tel-Aviv University), and DTI imaging (imaging of brain tracks). To do so, Sheba's Medical Center, Tel Hashomer, joined the project and is responsible for recruiting patients from the Department of Neurosurgery and Department of Rehabilitation and also is responsible for performing the needed tests.
The product that will be developed at the end of the Magneton project is expected to be a unique analysis method that allows examination and monitoring of the affected brain in both a functional and anatomically-structural ultra-high resolution.
- Conditions
- Traumatic Brain Injury (TBI)
- Being tested
- fMRI
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRIDevice
Also called EEG, CANTAB (computerized cognitive assessments)
fMRI scans, mapping brain connectivity using EEG in combination with eye-tracking technology (Brain Network Activation (BNA) technology developed by ELMINDA), characterizing of cortical layers using magnetic resonance (the CoLI technology developed by Tel-Aviv University), and Diffusion Tensor Imaging (DTI) imaging (imaging of brain tracks).
| Study group | Role | What they receive |
|---|---|---|
| EEG fMRI TBI Mild/Moderate-Severe severity | patient population who suffered a brain trauma (traumatic brain injury, TBI). with a Glasgow Coma Scale between 3-15 Receives: Device: fMRI | |
| EEG fMRI Control group | healthy subjects with out a traumatic brain injury Receives: Device: fMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
fMRI responses to a cognitive executive task
measure Blood oxygen dependent signal (BOLD) response in exposure to RAVEN's progressive matrices during fMRI scan, the difference in responses between the groups (severe TBI, mild TBI, healthy subjects), and the longitudinal change (in course of a year).
Measured: 12 months
MRI Structural changes
Using MRI scan and special protocols (DTI, COLI), The investigators will examine the difference between the groups (severe TBI, mild TBI, healthy subjects), and the longitudinal change (in course of a year).
Measured: 12 months
EEG responses to cognitive tasks in combination of an eye-tracking method
The investigators will examine the difference in responses between the groups (severe TBI, mild TBI, healthy subjects), and the longitudinal change (in course of a year).
Measured: 12 months
Cognitive scores on CANTAB (computerized cognitive assessments)
The investigators will examine the difference in responses to different cognitive exams between the groups (severe TBI, mild TBI, healthy subjects), and the longitudinal change (in course of a year).
Measured: 12 months
Secondary outcomes (1)
Correlations between the different methods
Correlations between the different methods - structural scans, functional scans, EEG, cognitive tasks, self-reported symptoms questionnaires and doctor's report.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study start21 Sep 2016
- Primary completion3 May 2018
- Study completion18 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain Injury (TBI)Studies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- ElMindA Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sheba Medical Center, Tel Aviv University
- Responsible party
- Sponsor
- Investigators
- Ofer Keren, MD, Principal investigator, Shebe Academic Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02878577
- Sponsor's protocol ID
- ELM-37
- Acronym
- TBI
- Status last verified
- Jan 2018
- First submitted
- 22 Aug 2016
- Last updated
- 4 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Alterations Following Traumatic Brain Injury Using Clinical Evaluation, Neuropsychological Assessments, Structural and Functional MRI and EEG Analysis
- ClinicalTrials.gov ID
- NCT02878577
- Acronym / sponsor ID
- TBI / ELM-37
- Conditions
- Traumatic Brain Injury (TBI)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- ElMindA LtdIndustry (pharma, biotech, devices)
- Collaborators
- Sheba Medical Center, Tel Aviv University
- Study start
- 21 Sep 2016 (actual)
- Primary completion
- 3 May 2018 (actual)
- Study completion
- 18 Jul 2018 (actual)
- First posted
- 25 Aug 2016 (estimated)
- 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 project, will combine the data collected from existing and innovative technologies: fMRI scans, mapping brain connectivity using EEG in combination with eye-tracking technology (the BNA technology developed by ELMINDA), characterizing of cortical layers using magnetic resonance (the CoLI technology developed by Tel-Aviv University), and DTI imaging (imaging of brain tracks). To do so, Sheba's Medical Center, Tel Hashomer, joined the project and is responsible for recruiting patients from the Department of Neurosurgery and Department of Rehabilitation and also is responsible for performing the needed tests.
Detailed description
This research project is the continuation of the NOFAR project, collaboration between ELMINDA and Tel-Aviv University, which included a proof of concept of the technology developed in the university to characterize cortical layers using magnetic resonance. In light of the promising results, the partners have decided to make another leap forward, and test the technology amongst specific patient population who suffered a brain trauma (traumatic brain injury, TBI).
Early and proper diagnosis of brain injury is critical, since it can prevent further complications to the patient's health. The tests that are currently available are limited in their ability to provide a comprehensive and accurate assessment of the injured brain: imaging exams such as CT, MRI and PET help identify the location and severity of the injury but cannot provide data on the cognitive and functional effects of the injury. On the other hand, neuropsychological tests only allow examination of current cognitive functioning, and cognitive decline quantification is done according to mathematical models and subjective assessments of the patient and his family. Therefore, this area is lacking and it is important to find an objective measure that enables quantification of brain injury that will be an indication of cognitive decline.
The current project, will last two years, and will combine the data collected from existing and innovative technologies: fMRI scans, mapping brain connectivity using EEG in combination with eye-tracking technology (the BNA technology developed by ELMINDA), characterizing of cortical layers using magnetic resonance (the CoLI technology developed by Tel-Aviv University), and DTI imaging (imaging of brain tracks). To do so, Sheba's Medical Center, Tel Hashomer, joined the project and is responsible for recruiting patients from the Department of Neurosurgery and Department of Rehabilitation and also is responsible for performing the needed tests.
The product that will be developed at the end of the Magneton project is expected to be a unique analysis method that allows examination and monitoring of the affected brain in both a functional and anatomically-structural ultra-high resolution.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EEG fMRI TBI Mild/Moderate-Severe severity | – | Device: fMRIpatient population who suffered a brain trauma (traumatic brain injury, TBI). with a Glasgow Coma Scale between 3-15 |
| EEG fMRI Control group | – | Device: fMRIhealthy subjects with out a traumatic brain injury |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- study population will include two groups of subjects: group 1: subjects after a traumatic brain injury group 2: control group
Key inclusion criteria (2 listed)
- Had the Glasgow coma scale score of 3-15 after the incident. (group 1)
- males and females Age: 18-60 (not during their military service).
Key exclusion criteria (16 listed)
- History of neurological disorders, mental retardation or a previous head injury.
- Current diagnosis or history of psychiatric disorders.
- Drugs and / or alcohol dependence or abuse existed prior to the head injury.
- Unconsciousness.
- Pregnancy.
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 |
|---|---|---|
| fMRIAlso: EEG, CANTAB (computerized cognitive assessments)fMRI scans, mapping brain connectivity using EEG in combination with eye-tracking technology (Brain Network Activation (BNA) technology developed by ELMINDA), characterizing of cortical layers using magnetic resonance (the CoLI technology developed by Tel-Aviv University), and Diffusion Tensor Imaging (DTI) imaging (imaging of brain tracks). | Device | EEG fMRI Control group, EEG fMRI TBI Mild/Moderate-Severe severity |
Primary outcome
fMRI responses to a cognitive executive task
Time frame: 12 months
measure Blood oxygen dependent signal (BOLD) response in exposure to RAVEN's progressive matrices during fMRI scan, the difference in responses between the groups (severe TBI, mild TBI, healthy subjects), and the longitudinal change (in course of a year).
MRI Structural changes
Time frame: 12 months
Using MRI scan and special protocols (DTI, COLI), The investigators will examine the difference between the groups (severe TBI, mild TBI, healthy subjects), and the longitudinal change (in course of a year).
EEG responses to cognitive tasks in combination of an eye-tracking method
Time frame: 12 months
The investigators will examine the difference in responses between the groups (severe TBI, mild TBI, healthy subjects), and the longitudinal change (in course of a year).
Cognitive scores on CANTAB (computerized cognitive assessments)
Time frame: 12 months
The investigators will examine the difference in responses to different cognitive exams between the groups (severe TBI, mild TBI, healthy subjects), and the longitudinal change (in course of a year).
1 secondary outcome
Correlations between the different methods
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2019.
- 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.
Ofer Keren, MD principal investigator
Shebe Academic 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 Traumatic Brain Injury (TBI), run by ElMindA 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 2 inclusion and 16 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 4 Jan 2019. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
fMRI responses to a cognitive executive task (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jan 2019.