Clinical trial NCT03034031: MR Imaging Study of TBI in Children
Official title: Classifying Neuro-imaging Measures Predicting Rehabilitation Outcome Following Pediatric Closed Head Injuries.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: TBI (Traumatic Brain Injury)
Keywords: Traumatic Brain Injury
Children
Pediatric
MRI
fMRI
Cognition
DTI
Longitudinal
Connectivity
DAI
Neuropsychology
Rehabilitation
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2017-01-27
Enrollment: 60
Sex: ALL
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: study population will include 1 group of subjects: group 1: young subjects, age 9-18, after traumatic brain injury

Brief summary: This project will combine the data collected from structural and functional MRI scans and neuropsychology performance post-TBI in children. Patients will be followed for a year, in order to examine the brain and cognitive recovery post head injury.

Detailed description: Traumatic brain injury in childhood has an cumulative effect that leads to impairments in cognitive functions such as deficits in memory, executive functions and attention. The cognitive impairment is the main cause of disabilities in the injured population, and has a different effect depending on the type and severity of the injury.

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.

Eligibility criteria: Inclusion Criteria:

1. Patients 9-18 years old, which are/were hospitalized in the Pediatric Rehabilitation Department, Sheba Medical Center
2. Glasgow coma scale score of 3-15.
3. Hebrew as mother-tongue

Exclusion Criteria:

1. History of neurological disorders, mental retardation or a previous head injury.
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.

Primary outcomes:
measure: Functional MRI
timeFrame: 12 months
measure: Structural MRI
timeFrame: 12 months
measure: neuropsychological tests
timeFrame: 12 months
Secondary outcomes:
measure: Associations between the cognitive performance and the imaging methods
timeFrame: 12 months
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba medical center Tel Hashomer
Study officials:
affiliation: Sheba Medical Center
name: Abigail Livny-Ezer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.