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Trial record 42 of 315 for:    Recruiting, Not yet recruiting, Available Studies | "Brain Injuries, Traumatic"

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

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ClinicalTrials.gov Identifier: NCT02878577
Recruitment Status : Recruiting
First Posted : August 25, 2016
Last Update Posted : January 17, 2018
Sponsor:
Collaborators:
Sheba Medical Center
Tel Aviv University
Information provided by (Responsible Party):
ElMindA Ltd

August 22, 2016
August 25, 2016
January 17, 2018
September 21, 2016
September 2018   (Final data collection date for primary outcome measure)
  • 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).
  • 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), we 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 ]
    We 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 ]
    We 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).
Complete list of historical versions of study NCT02878577 on ClinicalTrials.gov Archive Site
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.
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.
Not Provided
Not Provided
 
Monitoring the Alterations That Occur in the Brain Following Traumatic Brain Injury
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
study population will include two groups of subjects: group 1: subjects after a traumatic brain injury group 2: control group
Traumatic Brain Injury (TBI)
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 TBI Mild/Moderate-Severe severity
    patient population who suffered a brain trauma (traumatic brain injury, TBI). with a Glasgow Coma Scale between 3-15
    Intervention: Device: fMRI
  • EEG fMRI Control group
    healthy subjects with out a traumatic brain injury
    Intervention: Device: fMRI
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
Same as current
December 2018
September 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
Yes
Contact: Abigail Livny-Ezer, PHD +97254998805 abigail.livnyezer@gmail.com
Contact: Liran Korine, Bsc, MBA +972-9-9516476 ext.127 liran@elminda.com
Israel
 
 
NCT02878577
ELM-37
No
Not Provided
Plan to Share IPD: No
ElMindA Ltd
ElMindA Ltd
  • Sheba Medical Center
  • Tel Aviv University
Principal Investigator: Ofer Keren, MD Shebe Academic Medical Center
ElMindA Ltd
January 2018