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MR Imaging Study of TBI in Children (MISTIC)

S

Sheba Medical Center

Status

Enrolling

Conditions

TBI (Traumatic Brain Injury)

Study type

Observational

Funder types

Other

Identifiers

NCT03034031
3211-16-SMC

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

9 to 18 years old

Volunteers

No 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.

  7. Deafness or blindness. 9. Renal failure.

Trial contacts and locations

1

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Central trial contact

Abigail Livny-Ezer, PhD; Tamar Silberg, PhD

Data sourced from clinicaltrials.gov

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