Traumatic Brain Injury (TBI) Clinical Trial
— TBIOfficial title:
Monitoring Alterations Following Traumatic Brain Injury Using Clinical Evaluation, Neuropsychological Assessments, Structural and Functional MRI and EEG Analysis
NCT number | NCT02878577 |
Other study ID # | ELM-37 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 21, 2016 |
Est. completion date | July 18, 2018 |
Verified date | January 2018 |
Source | ElMindA Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Israel | The Chaim Sheba Medical Center | Tel Aviv |
Lead Sponsor | Collaborator |
---|---|
ElMindA Ltd | Sheba Medical Center, Tel Aviv University |
Israel,
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 |
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