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

Traumatic Brain Injury (TBI) Clinical Trial

— TBI  

Official title:

Monitoring Alterations Following Traumatic Brain Injury Using Clinical Evaluation, Neuropsychological Assessments, Structural and Functional MRI and EEG Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02878577
• Other study ID #: ELM-37
• Status: Completed
• Start date: September 21, 2016
• Est. completion date: July 18, 2018

Study information

• Verified date: January 2018
• Source: ElMindA Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: July 18, 2018
• Est. primary completion date: May 3, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury (TBI)
• Wounds and Injuries

Intervention

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).

Locations

Country	Name	City	State
Israel	The Chaim Sheba Medical Center	Tel Aviv

Sponsors (3)

Lead Sponsor	Collaborator
ElMindA Ltd	Sheba Medical Center, Tel Aviv University

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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