Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
60 participants
OBSERVATIONAL
2018-06-24
2025-10-31
Brief Summary
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Detailed Description
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Imaging after brain trauma serves as a useful diagnostic tool in identifying the head trauma's results. Therefore, in recent years, using imaging methods, studies have tried to find measures which will be able to predict the functional outcome after brain injury in children, and assist in developing a personalized rehabilitation program. The combination of advanced imaging techniques with neuropsychological assessment within the early stage of the injury and during a year of followup, will allow us to establish the relationship between those measures and the functional recovery result of the children. This multi-analysis will enable us to have a deeper understanding of the neuroplasticity process and the functional recovery after brain injury in the developing young brain.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
2. Glasgow coma scale score of 3-15.
3. Hebrew as mother-tongue
Exclusion Criteria
2. Current diagnosis or history of psychiatric disorders.
3. Cardiovascular instability.
4. Metabolic instability (water, electrolytes, sugar).
5. Fever or evidence of microbiological pollutant.
6. Uncontrolled seizures. 7 . Hydrocephalus.
8\. Deafness or blindness. 9. Renal failure.
9 Years
18 Years
ALL
No
Sponsors
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Sheba Medical Center
OTHER_GOV
Responsible Party
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Dr. Abigail livny-ezer
Head of functional neuromaging lab, Department of Diagnostic Imaging
Principal Investigators
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Abigail Livny-Ezer, PhD
Role: PRINCIPAL_INVESTIGATOR
Sheba Medical Center
Locations
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Sheba medical center Tel Hashomer
Ramat Gan, , Israel
Countries
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Central Contacts
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Facility Contacts
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References
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Livny A, Biegon A, Kushnir T, Harnof S, Hoffmann C, Fruchter E, Weiser M. Cognitive Deficits Post-Traumatic Brain Injury and Their Association with Injury Severity and Gray Matter Volumes. J Neurotrauma. 2017 Apr 1;34(7):1466-1472. doi: 10.1089/neu.2016.4598. Epub 2016 Dec 2.
Anderson VA, Anderson P, Northam E, Jacobs R, Mikiewicz O. Relationships between cognitive and behavioral measures of executive function in children with brain disease. Child Neuropsychol. 2002 Dec;8(4):231-40. doi: 10.1076/chin.8.4.231.13509.
Anderson V, Catroppa C. Recovery of executive skills following paediatric traumatic brain injury (TBI): a 2 year follow-up. Brain Inj. 2005 Jun;19(6):459-70. doi: 10.1080/02699050400004823.
Anderson V, Catroppa C, Morse S, Haritou F, Rosenfeld J. Recovery of intellectual ability following traumatic brain injury in childhood: impact of injury severity and age at injury. Pediatr Neurosurg. 2000 Jun;32(6):282-90. doi: 10.1159/000028956.
Keightley ML, Sinopoli KJ, Davis KD, Mikulis DJ, Wennberg R, Tartaglia MC, Chen JK, Tator CH. Is there evidence for neurodegenerative change following traumatic brain injury in children and youth? A scoping review. Front Hum Neurosci. 2014 Mar 19;8:139. doi: 10.3389/fnhum.2014.00139. eCollection 2014.
Other Identifiers
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3211-16-SMC
Identifier Type: -
Identifier Source: org_study_id