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RecruitingNCT03034031MISTICUpdated Nov 24, 2023

MR Imaging Study of TBI in Children

An observational study in TBI (Traumatic Brain Injury), sponsored by Sheba Medical Center. Recruiting at 1 site in Israel. Open to participants aged 9 Years to 18 Years. Per ClinicalTrials.gov, last updated 2023-11-24.

Sponsored by Sheba Medical Center · Observational

From the registry’s dates

  • Primary completion was expected by Oct 2024, 2 years ago, but the record still lists the study as recruiting.
  • Started Jun 2018; still recruiting 8 years 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
9 Years to 18 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • TBI (Traumatic Brain Injury)

Keywords

  • Traumatic Brain Injury
  • Children
  • Pediatric
  • MRI
  • fMRI
  • Cognition
  • DTI
  • Longitudinal
  • Connectivity
  • DAI
  • Neuropsychology
  • Rehabilitation
03

In context

Brain Injuries

2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.

This study's planned enrollment of 60 is below the median of 100 across 690 observational studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

Sheba Medical Center is the lead sponsor of 660 studies on the registry; 63 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
9 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
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

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

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.
  1. Deafness or blindness. 9. Renal failure.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Functional MRI

    fMRI brain activation to a cognitive tasks

    Time frame: 12 months

  2. Structural MRI

    MRI Structural changes using different methods

    Time frame: 12 months

  3. neuropsychological tests

    Cognitive scores on neuropsychological testing

    Time frame: 12 months

Secondary outcomes

  1. Associations between the cognitive performance and the imaging methods

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
  • Sheba medical center Tel Hashomer
    Ramat Gan, Israel
    Recruiting
08

References and documents

Publications

  • 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. PubMed 27750571 ↗
  • 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. PubMed 12759820 ↗
  • 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. PubMed 16101268 ↗
  • 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. PubMed 10971189 ↗
  • 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. PubMed 24678292 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03034031
Lead sponsor
Sheba Medical Center
Responsible party
Dr. Abigail livny-ezer (Head of functional neuromaging lab, Department of Diagnostic Imaging, Sheba Medical Center) — Principal investigator
First posted
Jan 27, 2017
Start date
Jun 24, 2018
Primary completion
Oct 2024 (estimated)
Completion
Oct 2025 (estimated)
Last update
Nov 24, 2023

Study contacts

Abigail Livny-Ezer, PhD
Contact
abigail.livnyezer@gmail.com
+972549988058
Tamar Silberg, PhD
Contact
tamarsilberg@gmail.com
+972507693933
Abigail Livny-Ezer, PhD
principal investigator · Sheba Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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