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

NCT02878577 | Completed

• 1 other identifier: ELM-37
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury (TBI)

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Correlations between the different methods

  12 months

Study Arms (2)

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

EEG fMRI Control group

healthy subjects with out a traumatic brain injury

Device: fMRI

Interventions

fMRI DEVICE

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).

Also known as: EEG, CANTAB (computerized cognitive assessments)

EEG fMRI Control group; EEG fMRI TBI Mild/Moderate-Severe severity

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• Had the Glasgow coma scale score of 3-15 after the incident. (group 1)
• males and females Age: 18-60 (not during their military service).

You may not qualify if:

• 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.

Sponsors & Collaborators

• ElMindA Ltd: lead
• Sheba Medical Center: collaborator
• Tel Aviv University: collaborator

Study Sites (1)

The Chaim Sheba Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Magnetic Resonance Imaging; Electroencephalography

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Neurological; Electrodiagnosis

Study Officials

• Ofer Keren, MD

  Shebe Academic Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2016
• First Posted: August 25, 2016
• Study Start: September 21, 2016
• Primary Completion: May 3, 2018
• Study Completion: July 18, 2018
• Last Updated: January 4, 2019

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)