<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/NCT04421898</url>
  </required_header>
  <id_info>
    <org_study_id>RECHMPL20_0303</org_study_id>
    <nct_id>NCT04421898</nct_id>
  </id_info>
  <brief_title>3D Characterisation of the Skull Base Deformation in Congenital Muscular Torticollis</brief_title>
  <official_title>3D Modelling and Morphometric Characterisation of the Skull Deformations in Congenital Muscular Torticollis : Development of Physiopathological Sequences</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>EA2415 - Montpellier University, Montpellier, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Montpellier</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>
      The congenital muscular torticollis (CMT) is defined by an abnormal posture of the head and&#xD;
      the neck compared to shoulders' level of the newborn. The mainly affected muscle is the&#xD;
      sternocleidomastoid muscle (SCM) causing a lateral inclination of the head on the side&#xD;
      affected by the CMT and a rotation on the opposite side. CMT comes with&#xD;
      asymmetricalndeformation of the skull or plagiocephaly, facial asymmetry, skull and&#xD;
      cranio-vertebral deformatioes in CMT are the results of a complex mechanism of biomechanical&#xD;
      stresses upon a developing skull. The hypothesis of a traction force on the base of the skull&#xD;
      from the SCM could explain most of all the asymmetrical deformatios encountered in CMT. It&#xD;
      would be associated to a compression force at the occipital level&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The congenital muscular torticollis (CMT) is defined by an abnormal posture of the head and&#xD;
      the neck compared to shoulders' level of the newborn. The mainly affected muscle is the&#xD;
      sternocleidomastoid muscle (SCM) causing a lateral inclination of the head on the side&#xD;
      affected by the CMT and a rotation on the opposite side. It is the third cause of neonatal&#xD;
      deformation and affect nearly one newborn out of six, most of the time transiently.&#xD;
&#xD;
      Three types of CMT exist : CMT secondary to a tonus disorder (postural torticollis), CMT&#xD;
      presenting a tumor on the SCM and CMT caused by a retraction and fibrosis of the SCM.&#xD;
&#xD;
      The exact aetiology of CMT is not well known. However, per partum intrauterine restrictive&#xD;
      stress is very much involved in the genesis of CMT.Treatment is mainly based on&#xD;
      physiotherapy, it needs to be started early and associated with parental education. In the&#xD;
      event of a failure of the physical therapy, a surgical treatment can be considered. CMT is a&#xD;
      risk factor for delayed psychomotor development and can lead to long term sequelae in motor&#xD;
      coordination.&#xD;
&#xD;
      CMT comes with asymmetrical deformation of the skull or plagiocephaly. Skull deformation in&#xD;
      plagiocephaly is a 3D deformation affecting the calvaria, the skull base and the face. The&#xD;
      skull base asymmetry can be found at the mastoid process of the petrous bone, insertion of&#xD;
      the SCM on the base of the skull. The facial asymmetry in CMT can have an aesthetic impact on&#xD;
      the face or a functional impact on the long term occlusion. CMT also come with abnormalities&#xD;
      of the junction between the skull and the vertebrae, they impact the cervical mobility and&#xD;
      foster premature arthrosis. The CMT care will modify the seriousness of the skull and face&#xD;
      deformation, severity is major in neglected or not treated CMT.&#xD;
&#xD;
      Plagiocephly, facial asymmetry, skull and cranio-vertebral deformation in CMT are the results&#xD;
      of a complex mechanism of biomechanical stresses upon a developing skull. These stresses&#xD;
      appear in a context of intrauterine postural distortions and/or during postnatal distorting&#xD;
      sequences. The SCM responsible for CMT is inserted on the mastoid process of the petrous bone&#xD;
      for its base of the skull insertion, the petrous bone is a fundamental component in the&#xD;
      biomechanics of the base of the skull.&#xD;
&#xD;
      The hypothesis of a traction force on the base of the skull from the SCM could explain most&#xD;
      of all the 3D asymmetrical deformation encountered in CMT. It would be associated to a&#xD;
      compression force at the occipital level particularly linked to a sleep position of the&#xD;
      infants on their back, position that is now recommended.&#xD;
&#xD;
      The traction force is different depending on the CMT with no or little force in postural&#xD;
      torticollis and strong and constant forces in torticollis with fibrosis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Anticipated">December 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>create a physiopathological 3D model of skull deformation for each type of CMTs)</measure>
    <time_frame>1 day</time_frame>
    <description>create a physiopathological 3D model of skull deformation for each type of CMTs)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Characterisation of the skull base asymmetry and cranioverterbral deformation</measure>
    <time_frame>1 day</time_frame>
    <description>Characterisation of the skull base asymmetry and cranioverterbral deformation</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Congenital Torticollis</condition>
  <condition>Positionnel Skull Deformation</condition>
  <arm_group>
    <arm_group_label>group 1</arm_group_label>
    <description>group 1 : infants with congenital muscular torticollis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group 2</arm_group_label>
    <description>group 2 : healthy , without congenital muscular torticollis</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Pathologic group : children with CMT and skull deformation Control group: healthy subject&#xD;
        from 0 to 36 month without CMT or skull deformation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  subjects with CMT and skull deformation referenced in Data base images of CT scan&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        - incomplete clinical or CT-scan data&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>36 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Guillaume CAPTIER, MD.PhD</last_name>
    <role>Study Director</role>
    <affiliation>University Hospital, Montpellier</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Guillaume CAPTIER, MD.PhD</last_name>
    <phone>4 67 33 95 81</phone>
    <phone_ext>33</phone_ext>
    <email>g-captier@chu-montpellier.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Magali bourgoin</last_name>
    <email>magali.bourgoin@etu.umontpellier.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Uhmontpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Guillaume Captier, MD.PhD</last_name>
      <phone>4 67 33 95 81</phone>
      <phone_ext>33</phone_ext>
      <email>g-captier@chu-montpellier.fr</email>
    </contact>
    <contact_backup>
      <last_name>Magali bourgoin</last_name>
    </contact_backup>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 8, 2020</last_update_submitted>
  <last_update_submitted_qc>June 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Skull base</keyword>
  <keyword>Petrous Bone</keyword>
  <keyword>Plagiocephaly</keyword>
  <keyword>Congenital Muscular Torticollis</keyword>
  <keyword>Sternocleidomastoid muscle</keyword>
  <keyword>Craniovertebral junction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Torticollis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>NC</ipd_description>
  </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/NCT04421898
org study id: RECHMPL20_0303
nct id: NCT04421898
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The congenital muscular torticollis (CMT) is defined by an abnormal posture of the head and
      the neck compared to shoulders' level of the newborn. The mainly affected muscle is the
      sternocleidomastoid muscle (SCM) causing a lateral inclination of the head on the side
      affected by the CMT and a rotation on the opposite side. CMT comes with
      asymmetricalndeformation of the skull or plagiocephaly, facial asymmetry, skull and
      cranio-vertebral deformatioes in CMT are the results of a complex mechanism of biomechanical
      stresses upon a developing skull. The hypothesis of a traction force on the base of the skull
      from the SCM could explain most of all the asymmetrical deformatios encountered in CMT. It
      would be associated to a compression force at the occipital level
The congenital muscular torticollis (CMT) is defined by an abnormal posture of the head and
      the neck compared to shoulders' level of the newborn. The mainly affected muscle is the
      sternocleidomastoid muscle (SCM) causing a lateral inclination of the head on the side
      affected by the CMT and a rotation on the opposite side. It is the third cause of neonatal
      deformation and affect nearly one newborn out of six, most of the time transiently.

      Three types of CMT exist : CMT secondary to a tonus disorder (postural torticollis), CMT
      presenting a tumor on the SCM and CMT caused by a retraction and fibrosis of the SCM.

      The exact aetiology of CMT is not well known. However, per partum intrauterine restrictive
      stress is very much involved in the genesis of CMT.Treatment is mainly based on
      physiotherapy, it needs to be started early and associated with parental education. In the
      event of a failure of the physical therapy, a surgical treatment can be considered. CMT is a
      risk factor for delayed psychomotor development and can lead to long term sequelae in motor
      coordination.

      CMT comes with asymmetrical deformation of the skull or plagiocephaly. Skull deformation in
      plagiocephaly is a 3D deformation affecting the calvaria, the skull base and the face. The
      skull base asymmetry can be found at the mastoid process of the petrous bone, insertion of
      the SCM on the base of the skull. The facial asymmetry in CMT can have an aesthetic impact on
      the face or a functional impact on the long term occlusion. CMT also come with abnormalities
      of the junction between the skull and the vertebrae, they impact the cervical mobility and
      foster premature arthrosis. The CMT care will modify the seriousness of the skull and face
      deformation, severity is major in neglected or not treated CMT.

      Plagiocephly, facial asymmetry, skull and cranio-vertebral deformation in CMT are the results
      of a complex mechanism of biomechanical stresses upon a developing skull. These stresses
      appear in a context of intrauterine postural distortions and/or during postnatal distorting
      sequences. The SCM responsible for CMT is inserted on the mastoid process of the petrous bone
      for its base of the skull insertion, the petrous bone is a fundamental component in the
      biomechanics of the base of the skull.

      The hypothesis of a traction force on the base of the skull from the SCM could explain most
      of all the 3D asymmetrical deformation encountered in CMT. It would be associated to a
      compression force at the occipital level particularly linked to a sleep position of the
      infants on their back, position that is now recommended.

      The traction force is different depending on the CMT with no or little force in postural
      torticollis and strong and constant forces in torticollis with fibrosis.
observational model: Case-Control
time perspective: Retrospective
measure: create a physiopathological 3D model of skull deformation for each type of CMTs)
time frame: 1 day
description: create a physiopathological 3D model of skull deformation for each type of CMTs)
measure: Characterisation of the skull base asymmetry and cranioverterbral deformation
time frame: 1 day
description: Characterisation of the skull base asymmetry and cranioverterbral deformation
arm group label: group 1
description: group 1 : infants with congenital muscular torticollis
arm group label: group 2
description: group 2 : healthy , without congenital muscular torticollis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 36 Years
healthy volunteers: No
last name: Guillaume CAPTIER, MD.PhD
role: Study Director
affiliation: University Hospital, Montpellier
last name: Guillaume CAPTIER, MD.PhD
phone: 4 67 33 95 81
phone ext: 33
email: g-captier@chu-montpellier.fr
last name: Magali bourgoin
email: magali.bourgoin@etu.umontpellier.fr
facility: 
status: Recruiting
contact: 
contact backup: 
country: France
responsible party type: Sponsor
mesh term: Torticollis
sharing ipd: Undecided
ipd description: NC