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Monitoring the Alterations That Occur in the Brain Following Traumatic Brain Injury (TBI)

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ClinicalTrials.gov Identifier: NCT02878577
Recruitment Status : Not yet recruiting
First Posted : August 25, 2016
Last Update Posted : August 26, 2016
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Traumatic Brain Injury (TBI) Device: fMRI

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

Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Monitoring Alterations Following Traumatic Brain Injury Using Clinical Evaluation, Neuropsychological Assessments, Structural and Functional MRI and EEG Analysis
Study Start Date : September 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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
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).
Other Names:
  • EEG
  • CANTAB (computerized cognitive assessments)
EEG fMRI Control group
healthy subjects with out a traumatic brain injury
Device: fMRI
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).
Other Names:
  • EEG
  • CANTAB (computerized cognitive assessments)


Outcome Measures

Primary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).

  4. 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).


Secondary Outcome Measures :
  1. Correlations between the different methods [ Time Frame: 12 months ]
    Correlations between the different methods - structural scans, functional scans, EEG, cognitive tasks, self-reported symptoms questionnaires and doctor's report.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   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
Criteria

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:

  • 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02878577


Contacts
Contact: Abigail Livny-Ezer, PHD +97254998805 abigail.livnyezer@gmail.com
Contact: Liran Korine, Bsc, MBA +972-9-9516476 ext.127 liran@elminda.com

Sponsors and Collaborators
ElMindA Ltd
Sheba Medical Center
Tel Aviv University
Investigators
Principal Investigator: Ofer Keren, MD Shebe Academic Medical Center
More Information

Responsible Party: ElMindA Ltd
ClinicalTrials.gov Identifier: NCT02878577     History of Changes
Other Study ID Numbers: ELM-37
First Posted: August 25, 2016    Key Record Dates
Last Update Posted: August 26, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System