NCT02878577

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 68 (actual)
• Sponsor: ElMindA Ltd · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

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)

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2016-09-21
• Primary completion: 2018-05-03
• Completion: 2018-07-18
• First posted: 2016-08-25
• Last updated: 2019-01-04

Locations

1 site across 1 country: Israel