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

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.

Study Overview

• Status: Completed
• Conditions: Traumatic Brain Injury (TBI)
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 68

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel
    • The Chaim Sheba Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	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).	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Collaborators and Investigators

• Sponsor: ElMindA Ltd
• Collaborators: Tel Aviv University; Sheba Medical Center
• Investigators: Principal Investigator: Ofer Keren, MD, Shebe Academic Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2016
• Primary Completion (Actual): May 3, 2018
• Study Completion (Actual): July 18, 2018

Study Registration Dates

• First Submitted: August 22, 2016
• First Submitted That Met QC Criteria: August 24, 2016
• First Posted (Estimate): August 25, 2016

Study Record Updates

• Last Update Posted (Actual): January 4, 2019
• Last Update Submitted That Met QC Criteria: January 3, 2019
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: ELM-37

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO