MR Imaging Study of TBI in Children

Recruiting

• Conditions: TBI (Traumatic Brain Injury)

• Registration Number: NCT03034031
• Lead Sponsor: Sheba Medical Center

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.

Study Timeline

• Study First Submitted: 2017-01-25
• Study First Submitted QC: 2017-01-25
• Study First Posted: 2017-01-27
• Study Start: 2018-06-24
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-22
• Last Update Posted: 2023-11-24
• Primary Completion: 2024-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

7. Deafness or blindness. 9. Renal failure.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional MRI	12 months	fMRI brain activation to a cognitive tasks
Structural MRI	12 months	MRI Structural changes using different methods
neuropsychological tests	12 months	Cognitive scores on neuropsychological testing

Secondary Outcome Measures

Name	Time	Method
Associations between the cognitive performance and the imaging methods	12 months

Trial Locations

Locations (1)

Sheba medical center Tel Hashomer; 🇮🇱 Ramat Gan, Israel