3D Characterisation of the Skull Base Deformation in Congenital Muscular Torticollis

3D Modelling and Morphometric Characterisation of the Skull Deformations in Congenital Muscular Torticollis : Development of Physiopathological Sequences

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

Study Overview

• Status: Recruiting
• Conditions: Congenital Torticollis; Positionnel Skull Deformation

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Guillaume Captier, MD.PhD; Phone Number: 33 4 67 33 95 81; Email: g-captier@chu-montpellier.fr
• Study Contact Backup: Name: Magali bourgoin; Email: magali.bourgoin@etu.umontpellier.fr

Study Locations

• France
  • Montpellier, France, 34295
    • Recruiting
    • Uhmontpellier
    • Contact: Guillaume Captier, MD.PhD; Phone Number: 33 4 67 33 95 81; Email: g-captier@chu-montpellier.fr
    • Contact: Magali bourgoin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 34 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Pathologic group : children with CMT and skull deformation Control group: healthy subject from 0 to 36 month without CMT or skull deformation

Description

Inclusion criteria:

• subjects with CMT and skull deformation referenced in Data base images of CT scan

Exclusion criteria:

- incomplete clinical or CT-scan data

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
group 1; group 1 : infants with congenital muscular torticollis
group 2; group 2 : healthy , without congenital muscular torticollis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
create a physiopathological 3D model of skull deformation for each type of CMTs)	create a physiopathological 3D model of skull deformation for each type of CMTs)	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characterisation of the skull base asymmetry and cranioverterbral deformation	Characterisation of the skull base asymmetry and cranioverterbral deformation	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: EA2415 - Montpellier University, Montpellier, France

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: June 4, 2020
• First Submitted That Met QC Criteria: June 4, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): June 11, 2020
• Last Update Submitted That Met QC Criteria: June 8, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Skull base; Petrous Bone; Plagiocephaly; Congenital Muscular Torticollis; Sternocleidomastoid muscle; Craniovertebral junction
• Additional Relevant MeSH Terms: Neurologic Manifestations; Dyskinesias; Dystonia; Torticollis
• Other Study ID Numbers: RECHMPL20_0303

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No