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CompletedNCT02878577TBIUpdated Jan 4, 2019

Monitoring the Alterations That Occur in the Brain Following Traumatic Brain Injury

An observational study in Traumatic Brain Injury (TBI), sponsored by ElMindA Ltd. Completed at 1 site in Israel. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-04.

Sponsored by ElMindA Ltd · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
68
Ages
18 Years to 60 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Traumatic Brain Injury (TBI)
03

In context

Brain Injuries, Traumatic

1,818 studies on the registry are indexed under Brain Injuries, Traumatic; 460 are open to participants now.

This study's enrollment of 68 is below the median of 119 across 579 observational studies indexed under Brain Injuries, Traumatic.

Browse Brain Injuries, Traumatic studies →

Lead sponsor

ElMindA Ltd is the lead sponsor of 20 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

study population will include two groups of subjects: group 1: subjects after a traumatic brain injury group 2: control group

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Had the Glasgow coma scale score of 3-15 after the incident. (group 1)
  2. males and females Age: 18-60 (not during their military service).

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
68 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

    Device: fMRI

  • EEG fMRI Control group

    healthy subjects with out a traumatic brain injury

    Device: fMRI

Interventions

  • DevicefMRI

    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).

    Also known as: EEG, CANTAB (computerized cognitive assessments)

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What researchers measure

Primary outcomes

  1. 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).

    Time frame: 12 months

  2. 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).

    Time frame: 12 months

  3. 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).

    Time frame: 12 months

  4. 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).

    Time frame: 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.

    Time frame: 12 months

07

Study locations

1 site
  • The Chaim Sheba Medical Center
    Tel Aviv, Israel
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2016 to primary completion in May 2018, 19 months.

Of 265 observational studies under Brain Injuries, Traumatic, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 85. This study's 19 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 22, 2016
First posted
Aug 25, 2016
StartActual
Sep 21, 2016
Primary completionActual
May 3, 2018
CompletionActual
Jul 18, 2018
Last update
Jan 4, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 4, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02878577
Lead sponsor
ElMindA Ltd
Collaborators
Sheba Medical Center, Tel Aviv University
Responsible party
Sponsor
First posted
Aug 25, 2016
Start date
Sep 21, 2016
Primary completion
May 3, 2018
Completion
Jul 18, 2018
Last update
Jan 4, 2019

Study contacts

Ofer Keren, MD
principal investigator · Shebe Academic Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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