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Clinical Trials/NCT03034031
NCT03034031
Recruiting
Not Applicable

Classifying Neuro-imaging Measures Predicting Rehabilitation Outcome Following Pediatric Closed Head Injuries.

Sheba Medical Center1 site in 1 country60 target enrollmentJune 24, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
TBI (Traumatic Brain Injury)
Sponsor
Sheba Medical Center
Enrollment
60
Locations
1
Primary Endpoint
Functional MRI
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 24, 2018
End Date
October 2025
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Abigail livny-ezer

Head of functional neuromaging lab, Department of Diagnostic Imaging

Sheba Medical Center

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • History of neurological disorders, mental retardation or a previous head injury.
  • Current diagnosis or history of psychiatric disorders.
  • Cardiovascular instability.
  • Metabolic instability (water, electrolytes, sugar).
  • Fever or evidence of microbiological pollutant.
  • Uncontrolled seizures. 7 . Hydrocephalus.
  • Deafness or blindness.
  • Renal failure.

Outcomes

Primary Outcomes

Functional MRI

Time Frame: 12 months

fMRI brain activation to a cognitive tasks

Structural MRI

Time Frame: 12 months

MRI Structural changes using different methods

neuropsychological tests

Time Frame: 12 months

Cognitive scores on neuropsychological testing

Secondary Outcomes

  • Associations between the cognitive performance and the imaging methods(12 months)

Study Sites (1)

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