Monitoring Alterations Following Traumatic Brain Injury Using Clinical Evaluation, Neuropsychological Assessments, Structural and Functional MRI and EEG Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- EEG responses to cognitive tasks in combination of an eye-tracking method
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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
结局指标
主要结局
EEG responses to cognitive tasks in combination of an eye-tracking method
时间窗: 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).
MRI Structural changes
时间窗: 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).
Cognitive scores on CANTAB (computerized cognitive assessments)
时间窗: 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
时间窗: 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).
次要结局
- Correlations between the different methods(12 months)