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MR Imaging Study of TBI in Children (MISTIC)

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ClinicalTrials.gov Identifier: NCT03034031
Recruitment Status : Not yet recruiting
First Posted : January 27, 2017
Last Update Posted : January 31, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Abigail livny-ezer, 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.

Condition or disease
TBI (Traumatic Brain 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.


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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Classifying Neuro-imaging Measures Predicting Rehabilitation Outcome Following Pediatric Closed Head Injuries.
Study Start Date : January 2017
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Functional MRI [ Time Frame: 12 months ]
    fMRI brain activation to a cognitive tasks

  2. Structural MRI [ Time Frame: 12 months ]
    MRI Structural changes using different methods

  3. neuropsychological tests [ Time Frame: 12 months ]
    Cognitive scores on neuropsychological testing


Secondary Outcome Measures :
  1. Associations between the cognitive performance and the imaging methods [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   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
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03034031


Contacts
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Contact: Abigail Livny-Ezer, PhD abigail.livnyezer@gmail.com
Contact: Tamar Silberg, PhD tamarsilberg@gmail.com

Sponsors and Collaborators
Sheba Medical Center
Investigators
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Principal Investigator: Abigail Livny-Ezer, PhD Sheba Medical Center

Publications:
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Responsible Party: Dr. Abigail livny-ezer, Head of functional neuromaging lab, Department of Diagnostic Imaging, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT03034031     History of Changes
Other Study ID Numbers: 3211-16-SMC
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Abigail livny-ezer, Sheba Medical Center:
Traumatic Brain Injury
Rehabilitation
Children
Pediatric
MRI
fMRI
Cognition
DTI
Longitudinal
Connectivity
DAI
Neuropsychology

Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries