<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/NCT03811626</url>
  </required_header>
  <id_info>
    <org_study_id>2012-A00015-38</org_study_id>
    <nct_id>NCT03811626</nct_id>
  </id_info>
  <brief_title>Efficacy of Multidimensional Management of Mild Traumatic Brain Injury</brief_title>
  <official_title>Efficacy of Multidimensional Management of Mild Traumatic Brain Injury : A Randomised Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut de Recherche sur la Moelle épinière et l'Encéphale</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut de Recherche sur la Moelle épinière et l'Encéphale</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>
      Unfavorable outcomes (UO) are seen in 15 to 20% of patients with mild traumatic brain injury&#xD;
      (mTBI). Early identification of patients at risk for UO is crucial for suitable management to&#xD;
      be initiated, increasing their chances for a return to a normal life. The investigators&#xD;
      previously developed a diagnostic tool enabling early identification (8 to 21 days after the&#xD;
      injury) of patients likely to develop UO. In the present study, the investigators examined&#xD;
      the value and beneficial effects of early multidimensional management (MM) on prognosis. The&#xD;
      investigators used a diagnostic tool to classify 221 mTBI patients as UO (97) or FO&#xD;
      (favorable outcome) (124). Patients whose initial risk factors point to UO are at risk of&#xD;
      developing post-concussion syndrome (PCS). UO patients were randomized into 2 groups: a group&#xD;
      that underwent MM (cognitive-behavioral rehabilitation) (34) and a group with no specific&#xD;
      management (46). At 6 months, these 2 groups were compared and the impact of MM on outcome&#xD;
      was assessed. Among patients initially classified as FO (101), 95% had FO at 6 months and&#xD;
      only 5 had PCS as defined by DSM-IV classification. Of the UO patients who received MM, 94%&#xD;
      had no PCS 6 months after injury, whereas 52% of the UO patients who did not receive MM had&#xD;
      persistent PCS. The effect of MM on the recovery of patients at 6 months, once adjusted for&#xD;
      the main confounding factors, was statistically significant (p&lt;0.001). These results show&#xD;
      that the initiation of MM after early identification of at-risk mTBI patients can&#xD;
      considerably improves their prognosis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2012</start_date>
  <completion_date type="Actual">June 30, 2013</completion_date>
  <primary_completion_date type="Actual">June 30, 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in quality of life</measure>
    <time_frame>Baseline, 6 months -</time_frame>
    <description>Change in quality of life assessed by QOLIBRI (Quality of Life after Brain Injury) Scale - QOLIBRI scale assess health-related quality of life (HRQoL) of individuals after traumatic brain injury. QOLIBRI is a comprehensive questionnaire with 37 items covering six dimensions of HRQoL after TBI. The QOLIBRI scores are reported on a 0-100 scale , where 0=worst possible quality of life and 100=best possible quality of life.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">221</enrollment>
  <condition>Mild Traumatic Brain Injury</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient who underwent cognitive-behavioral rehabilitation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Comparator</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patient with no specific management</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>cognitive-behavioral rehabilitation</intervention_name>
    <description>Combination of clinical examination and neuropsychological and psychological tests</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Patients aged 18 to 65 who have suffered mTBI, have health care coverage, who understand&#xD;
        French, who can be followed for 6 months, and who are able to understand, reply, and&#xD;
        cooperate.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient intubated and/or ventilated and/or sedated upon arrival at hospital&#xD;
&#xD;
          -  Patient with injury to the medulla and with neurological signs or multiple injuries&#xD;
             (at least 1 of which is life-threatening)&#xD;
&#xD;
          -  Brain injury incurred during a suicide attempt&#xD;
&#xD;
          -  Patient presenting psychiatric or psychological disorders that are debilitating and/or&#xD;
             interfere with follow-up and/or evaluation&#xD;
&#xD;
          -  Psychoactive treatment ongoing at the time of injury&#xD;
&#xD;
          -  History of hospitalization in specialized a psychiatric setting and/or sick leave for&#xD;
             psychological reasons&#xD;
&#xD;
          -  Patient with a neurological disorder&#xD;
&#xD;
          -  Patient with substance dependence&#xD;
&#xD;
          -  Subject under guardianship or wardship&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Chu Bicetre</name>
      <address>
        <city>Le Kremlin-Bicêtre</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chu Montpellier</name>
      <address>
        <city>Montpellier</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chu Bichat/Beaujon</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU St ANTOINE</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chu Tenon</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chu Rouen</name>
      <address>
        <city>Rouen</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/29312112</url>
    <description>Early Detection of Poor Outcome after Mild Traumatic Brain Injury: Predictive Factors Using a Multidimensional Approach a Pilot Study.</description>
  </link>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 18, 2019</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>January 23, 2019</last_update_submitted>
  <last_update_submitted_qc>January 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Mild TBI</keyword>
  <keyword>quality of life</keyword>
  <keyword>coping strategies</keyword>
  <keyword>symptoms</keyword>
  <keyword>neuropsychological tests</keyword>
  <keyword>pain</keyword>
  <keyword>memory reactive</keyword>
  <keyword>Cognitive dimension</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>
    <mesh_term>Brain Concussion</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <!-- 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/NCT03811626
org study id: 2012-A00015-38
nct id: NCT03811626
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Unfavorable outcomes (UO) are seen in 15 to 20% of patients with mild traumatic brain injury
      (mTBI). Early identification of patients at risk for UO is crucial for suitable management to
      be initiated, increasing their chances for a return to a normal life. The investigators
      previously developed a diagnostic tool enabling early identification (8 to 21 days after the
      injury) of patients likely to develop UO. In the present study, the investigators examined
      the value and beneficial effects of early multidimensional management (MM) on prognosis. The
      investigators used a diagnostic tool to classify 221 mTBI patients as UO (97) or FO
      (favorable outcome) (124). Patients whose initial risk factors point to UO are at risk of
      developing post-concussion syndrome (PCS). UO patients were randomized into 2 groups: a group
      that underwent MM (cognitive-behavioral rehabilitation) (34) and a group with no specific
      management (46). At 6 months, these 2 groups were compared and the impact of MM on outcome
      was assessed. Among patients initially classified as FO (101), 95% had FO at 6 months and
      only 5 had PCS as defined by DSM-IV classification. Of the UO patients who received MM, 94%
      had no PCS 6 months after injury, whereas 52% of the UO patients who did not receive MM had
      persistent PCS. The effect of MM on the recovery of patients at 6 months, once adjusted for
      the main confounding factors, was statistically significant (p<0.001). These results show
      that the initiation of MM after early identification of at-risk mTBI patients can
      considerably improves their prognosis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Change in quality of life
time frame: Baseline, 6 months -
description: Change in quality of life assessed by QOLIBRI (Quality of Life after Brain Injury) Scale - QOLIBRI scale assess health-related quality of life (HRQoL) of individuals after traumatic brain injury. QOLIBRI is a comprehensive questionnaire with 37 items covering six dimensions of HRQoL after TBI. The QOLIBRI scores are reported on a 0-100 scale , where 0=worst possible quality of life and 100=best possible quality of life.
arm group label: Intervention
arm group type: Experimental
description: Patient who underwent cognitive-behavioral rehabilitation
arm group label: Comparator
arm group type: No Intervention
description: Patient with no specific management
intervention type: Procedure
intervention name: cognitive-behavioral rehabilitation
description: Combination of clinical examination and neuropsychological and psychological tests
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
url: https://www.ncbi.nlm.nih.gov/pubmed/29312112
description: Early Detection of Poor Outcome after Mild Traumatic Brain Injury: Predictive Factors Using a Multidimensional Approach a Pilot Study.
responsible party type: Sponsor
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Brain Concussion
mesh term: Wounds and Injuries