MR Imaging Study of TBI in Children

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03034031

Acronym

MISTIC

Enrollment

Registered

2017-01-27

Start date

2018-06-24

Completion date

2025-10-31

Last updated

2023-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

TBI (Traumatic Brain Injury)

Keywords

Traumatic Brain Injury, Children, Pediatric, MRI, fMRI, Cognition, DTI, Longitudinal, Connectivity, DAI, Neuropsychology, Rehabilitation

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

9 Years to 18 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
Associations between the cognitive performance and the imaging methods	12 months

Countries

Israel

Contacts

Primary ContactAbigail Livny-Ezer, PhD

abigail.livnyezer@gmail.com+972549988058

Backup ContactTamar Silberg, PhD

tamarsilberg@gmail.com+972507693933

Outcome results