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MR Imaging Study of TBI in Children (MISTIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03034031
Recruitment Status : Recruiting
First Posted : January 27, 2017
Last Update Posted : June 14, 2019
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.
Actual Study Start Date : June 24, 2018
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

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 identifier (NCT number): NCT03034031

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Contact: Abigail Livny-Ezer, PhD +972549988058
Contact: Tamar Silberg, PhD +972507693933

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Sheba medical center Tel Hashomer Recruiting
Ramat Gan, Israel
Contact: Reut Moran, MsC    +972523532982   
Sponsors and Collaborators
Sheba Medical Center
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Principal Investigator: Abigail Livny-Ezer, PhD Sheba Medical Center
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Responsible Party: Dr. Abigail livny-ezer, Head of functional neuromaging lab, Department of Diagnostic Imaging, Sheba Medical Center Identifier: NCT03034031    
Other Study ID Numbers: 3211-16-SMC
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
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
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System