<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03034031</url>
  </required_header>
  <id_info>
    <org_study_id>3211-16-SMC</org_study_id>
    <nct_id>NCT03034031</nct_id>
  </id_info>
  <brief_title>MR Imaging Study of TBI in Children</brief_title>
  <acronym>MISTIC</acronym>
  <official_title>Classifying Neuro-imaging Measures Predicting Rehabilitation Outcome Following Pediatric Closed Head Injuries.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sheba Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sheba Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This project will combine the data collected from structural and functional MRI scans and&#xD;
      neuropsychology performance post-TBI in children. Patients will be followed for a year, in&#xD;
      order to examine the brain and cognitive recovery post head injury.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Traumatic brain injury in childhood has an cumulative effect that leads to impairments in&#xD;
      cognitive functions such as deficits in memory, executive functions and attention. The&#xD;
      cognitive impairment is the main cause of disabilities in the injured population, and has a&#xD;
      different effect depending on the type and severity of the injury.&#xD;
&#xD;
      Imaging after brain trauma serves as a useful diagnostic tool in identifying the head&#xD;
      trauma's results. Therefore, in recent years, using imaging methods, studies have tried to&#xD;
      find measures which will be able to predict the functional outcome after brain injury in&#xD;
      children, and assist in developing a personalized rehabilitation program. The combination of&#xD;
      advanced imaging techniques with neuropsychological assessment within the early stage of the&#xD;
      injury and during a year of followup, will allow us to establish the relationship between&#xD;
      those measures and the functional recovery result of the children. This multi-analysis will&#xD;
      enable us to have a deeper understanding of the neuroplasticity process and the functional&#xD;
      recovery after brain injury in the developing young brain.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 24, 2018</start_date>
  <completion_date type="Anticipated">June 2022</completion_date>
  <primary_completion_date type="Anticipated">June 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Functional MRI</measure>
    <time_frame>12 months</time_frame>
    <description>fMRI brain activation to a cognitive tasks</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Structural MRI</measure>
    <time_frame>12 months</time_frame>
    <description>MRI Structural changes using different methods</description>
  </primary_outcome>
  <primary_outcome>
    <measure>neuropsychological tests</measure>
    <time_frame>12 months</time_frame>
    <description>Cognitive scores on neuropsychological testing</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Associations between the cognitive performance and the imaging methods</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">60</enrollment>
  <condition>TBI (Traumatic Brain Injury)</condition>
  <eligibility>
    <study_pop>
      <textblock>
        study population will include 1 group of subjects: group 1: young subjects, age 9-18, after&#xD;
        traumatic brain injury&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients 9-18 years old, which are/were hospitalized in the Pediatric Rehabilitation&#xD;
             Department, Sheba Medical Center&#xD;
&#xD;
          2. Glasgow coma scale score of 3-15.&#xD;
&#xD;
          3. Hebrew as mother-tongue&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of neurological disorders, mental retardation or a previous head injury.&#xD;
&#xD;
          2. Current diagnosis or history of psychiatric disorders.&#xD;
&#xD;
          3. Cardiovascular instability.&#xD;
&#xD;
          4. Metabolic instability (water, electrolytes, sugar).&#xD;
&#xD;
          5. Fever or evidence of microbiological pollutant.&#xD;
&#xD;
          6. Uncontrolled seizures. 7 . Hydrocephalus.&#xD;
&#xD;
        8. Deafness or blindness. 9. Renal failure.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>9 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Abigail Livny-Ezer, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sheba Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Abigail Livny-Ezer, PhD</last_name>
    <phone>+972549988058</phone>
    <email>abigail.livnyezer@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Tamar Silberg, PhD</last_name>
    <phone>+972507693933</phone>
    <email>tamarsilberg@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Sheba medical center Tel Hashomer</name>
      <address>
        <city>Ramat Gan</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Reut Moran, MsC</last_name>
      <phone>+972523532982</phone>
      <email>reutim007@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>27750571</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>12759820</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>16101268</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>10971189</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>24678292</PMID>
  </reference>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>January 25, 2017</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>June 13, 2019</last_update_submitted>
  <last_update_submitted_qc>June 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sheba Medical Center</investigator_affiliation>
    <investigator_full_name>Dr. Abigail livny-ezer</investigator_full_name>
    <investigator_title>Head of functional neuromaging lab, Department of Diagnostic Imaging</investigator_title>
  </responsible_party>
  <keyword>Traumatic Brain Injury</keyword>
  <keyword>Children</keyword>
  <keyword>Pediatric</keyword>
  <keyword>MRI</keyword>
  <keyword>fMRI</keyword>
  <keyword>Cognition</keyword>
  <keyword>DTI</keyword>
  <keyword>Longitudinal</keyword>
  <keyword>Connectivity</keyword>
  <keyword>DAI</keyword>
  <keyword>Neuropsychology</keyword>
  <keyword>Rehabilitation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Brain Injuries, Traumatic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03034031
org study id: 3211-16-SMC
nct id: NCT03034031
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Functional MRI
time frame: 12 months
description: fMRI brain activation to a cognitive tasks
measure: Structural MRI
time frame: 12 months
description: MRI Structural changes using different methods
measure: neuropsychological tests
time frame: 12 months
description: Cognitive scores on neuropsychological testing
measure: Associations between the cognitive performance and the imaging methods
time frame: 12 months
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 9 Years
maximum age: 18 Years
healthy volunteers: No
last name: Abigail Livny-Ezer, PhD
role: Principal Investigator
affiliation: Sheba Medical Center
last name: Abigail Livny-Ezer, PhD
phone: +972549988058
email: abigail.livnyezer@gmail.com
last name: Tamar Silberg, PhD
phone: +972507693933
email: tamarsilberg@gmail.com
facility: 
status: Recruiting
contact: 
country: Israel
citation: 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.
PMID: 27750571
citation: 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.
PMID: 12759820
citation: 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.
PMID: 16101268
citation: 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.
PMID: 10971189
citation: 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.
PMID: 24678292
responsible party type: Principal Investigator
investigator affiliation: Sheba Medical Center
investigator full name: Dr. Abigail livny-ezer
investigator title: Head of functional neuromaging lab, Department of Diagnostic Imaging
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
sharing ipd: Undecided