<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/NCT02988609</url>
  </required_header>
  <id_info>
    <org_study_id>RC31/15/7730</org_study_id>
    <nct_id>NCT02988609</nct_id>
  </id_info>
  <brief_title>Concussion in Rugby Players: a Pilot Study of Neural Recovery Using fMRI</brief_title>
  <acronym>RugbyCom</acronym>
  <official_title>Concussion in Rugby Players: a Pilot Study of Neural Recovery Using Functional Magnetic Resonance Imaging (fMRI)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Toulouse</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Toulouse</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 study assess the putative persistence of neural damage using resting state fMRI after&#xD;
      concussion in rugby player once they have clinically recovered. The hypothesis is that&#xD;
      despite a clinical recovery (absence of symptoms; neurological and neuropsychological&#xD;
      examination returned to normal) connectivity map obtained using resting state fMRI are&#xD;
      significantly different from a group of control subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Resting state fMRI has shown to be a sensitive tool to assess neural damage after concussion.&#xD;
      It seems more sensible than structural MRI including DTI. the study goal will be to assess&#xD;
      rugby players using fMRI at 3 different times after concussion: just after concussion (V1),&#xD;
      once players have clinically recovered (V2) and 3 months after V2 (V3). The study would&#xD;
      specifically like to challenge clinical examination supposed to be normal at V2 to&#xD;
      connectivity maps using resting state fMRI preformed at the same time. fMRI performed at V1&#xD;
      and V3 will serve as comparators (respectively very altered at V1 and back to normal at V3).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    difficulty in enrollment and changes in methodology&#xD;
  </why_stopped>
  <start_date type="Actual">September 2016</start_date>
  <completion_date type="Actual">October 10, 2022</completion_date>
  <primary_completion_date type="Actual">August 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference of connectivity maps between the players with concussion and the group control</measure>
    <time_frame>up to 1 month</time_frame>
    <description>connectivity maps obtained during a 10 minutes resting state fMRI at V2</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difference of connectivity maps between the players with concussion and the group control</measure>
    <time_frame>up to 3 months</time_frame>
    <description>Connectivity maps obtained during a 10 minutes resting state fMRI at V1 and V3</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>neuropsychological questionnaire</measure>
    <time_frame>up to 3 months</time_frame>
    <description>Scores obtained the neuropsychological assessment. Memory, attention and executive functions will be assessed using validated tools.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>neurophysiological data</measure>
    <time_frame>up to 3 months</time_frame>
    <description>Structural imaging data (DTI)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Concussion</condition>
  <arm_group>
    <arm_group_label>Concussion Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Players with a recent (&lt;72 hours) history of concussion will be assessed 3 times. just after concussion, after disappearance of clinical symptoms and 3 months after the previous visit. During each visit, participant will undergo a neurological and a neuropsychological assessment and a structural and resting state fMRI.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>a control group with no history of concussion will be the comparator. Participants will be assessed 3 times. Visits will be the same for the control group and duration between visits in this group will be matched to the concussion group. During each visit, participant will undergo a neurological and a neuropsychological assessment and a structural and resting state fMRI.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>fMRI</intervention_name>
    <description>fMRI at 3 different times after concussion: just after concussion (V1), once players have clinically recovered (V2) and 3 months after V2 (V3).</description>
    <arm_group_label>Concussion Group</arm_group_label>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  no neurological or psychiatric disease&#xD;
&#xD;
          -  recent history of concussion (&lt;3 months) according to the Rugby French Federation&#xD;
             criteria.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to be assessed by MRI&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David BRAUGE, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>U H Toulouse</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Smits M, Houston GC, Dippel DW, Wielopolski PA, Vernooij MW, Koudstaal PJ, Hunink MG, van der Lugt A. Microstructural brain injury in post-concussion syndrome after minor head injury. Neuroradiology. 2011 Aug;53(8):553-63. doi: 10.1007/s00234-010-0774-6. Epub 2010 Oct 6.</citation>
    <PMID>20924757</PMID>
  </reference>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>May 13, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>August 22, 2023</last_update_submitted>
  <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</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/NCT02988609
org study id: RC31/15/7730
nct id: NCT02988609
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study assess the putative persistence of neural damage using resting state fMRI after
      concussion in rugby player once they have clinically recovered. The hypothesis is that
      despite a clinical recovery (absence of symptoms; neurological and neuropsychological
      examination returned to normal) connectivity map obtained using resting state fMRI are
      significantly different from a group of control subjects.
Resting state fMRI has shown to be a sensitive tool to assess neural damage after concussion.
      It seems more sensible than structural MRI including DTI. the study goal will be to assess
      rugby players using fMRI at 3 different times after concussion: just after concussion (V1),
      once players have clinically recovered (V2) and 3 months after V2 (V3). The study would
      specifically like to challenge clinical examination supposed to be normal at V2 to
      connectivity maps using resting state fMRI preformed at the same time. fMRI performed at V1
      and V3 will serve as comparators (respectively very altered at V1 and back to normal at V3).
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Difference of connectivity maps between the players with concussion and the group control
time frame: up to 1 month
description: connectivity maps obtained during a 10 minutes resting state fMRI at V2
measure: Difference of connectivity maps between the players with concussion and the group control
time frame: up to 3 months
description: Connectivity maps obtained during a 10 minutes resting state fMRI at V1 and V3
measure: neuropsychological questionnaire
time frame: up to 3 months
description: Scores obtained the neuropsychological assessment. Memory, attention and executive functions will be assessed using validated tools.
measure: neurophysiological data
time frame: up to 3 months
description: Structural imaging data (DTI)
arm group label: Concussion Group
arm group type: Experimental
description: Players with a recent (<72 hours) history of concussion will be assessed 3 times. just after concussion, after disappearance of clinical symptoms and 3 months after the previous visit. During each visit, participant will undergo a neurological and a neuropsychological assessment and a structural and resting state fMRI.
arm group label: Control Group
arm group type: Active Comparator
description: a control group with no history of concussion will be the comparator. Participants will be assessed 3 times. Visits will be the same for the control group and duration between visits in this group will be matched to the concussion group. During each visit, participant will undergo a neurological and a neuropsychological assessment and a structural and resting state fMRI.
intervention type: Device
intervention name: fMRI
description: fMRI at 3 different times after concussion: just after concussion (V1), once players have clinically recovered (V2) and 3 months after V2 (V3).
arm group label: Concussion Group
arm group label: Control Group
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: David BRAUGE, MD
role: Principal Investigator
affiliation: U H Toulouse
facility: 
country: France
citation: Smits M, Houston GC, Dippel DW, Wielopolski PA, Vernooij MW, Koudstaal PJ, Hunink MG, van der Lugt A. Microstructural brain injury in post-concussion syndrome after minor head injury. Neuroradiology. 2011 Aug;53(8):553-63. doi: 10.1007/s00234-010-0774-6. Epub 2010 Oct 6.
PMID: 20924757
responsible party type: Sponsor
sharing ipd: No