Congenital TorticollisNCT04421898
3D Characterisation of the Skull Base Deformation in Congenital Muscular Torticollis
An observational study of Congenital Torticollis and Positionnel Skull Deformation, run by University Hospital, Montpellier at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages Up to 36 years
- Conditions the study is for
- Congenital Torticollis, Positionnel Skull Deformation
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2020to 30 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 36 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pathologic group : children with CMT and skull deformation Control group: healthy subject from 0 to 36 month without CMT or skull deformation
Who may be able to join
- subjects with CMT and skull deformation referenced in Data base images of CT scan
Who cannot join
- incomplete clinical or CT-scan data
Trial locations and contacts
1 site in 1 country.
Magali bourgoin contact
France1 site, 1 recruiting
- Recruiting
Uhmontpellier
Montpellier, 34295
Guillaume Captier, MD.PhD, 4 67 33 95 81 ext. 33, g-captier@chu-montpellier.fr
Magali bourgoin
About this study
Official title: 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
Read the 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.
- Keywords
- Skull base, Petrous Bone, Plagiocephaly, Congenital Muscular Torticollis, Sternocleidomastoid muscle, Craniovertebral junction
- Medical subject headings
- Congenital torticollis, Plagiocephaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| group 1 | group 1 : infants with congenital muscular torticollis | |
| group 2 | group 2 : healthy , without congenital muscular torticollis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 day
Secondary outcomes (1)
Characterisation of the skull base asymmetry and cranioverterbral deformation
Characterisation of the skull base asymmetry and cranioverterbral deformation
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start1 Jun 2020
- Primary completion1 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital TorticollisStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- EA2415 - Montpellier University, Montpellier, France
- Responsible party
- Sponsor
- Investigators
- Guillaume CAPTIER, MD.PhD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04421898
- Sponsor's protocol ID
- RECHMPL20_0303
- Status last verified
- Jun 2020
- First submitted
- 4 Jun 2020
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Modelling and Morphometric Characterisation of the Skull Deformations in Congenital Muscular Torticollis : Development of Physiopathological Sequences
- ClinicalTrials.gov ID
- NCT04421898
- Acronym / sponsor ID
- RECHMPL20_0303
- Keywords
- Skull base, Petrous Bone, Plagiocephaly, Congenital Muscular Torticollis, Sternocleidomastoid muscle, Craniovertebral junction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- EA2415 - Montpellier University, Montpellier, France
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | –group 1 : infants with congenital muscular torticollis |
| group 2 | – | –group 2 : healthy , without congenital muscular torticollis |
Who may qualify
- Ages
- Up to 36 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pathologic group : children with CMT and skull deformation Control group: healthy subject from 0 to 36 month without CMT or skull deformation
Key inclusion criteria (1 listed)
- subjects with CMT and skull deformation referenced in Data base images of CT scan
Key exclusion criteria (1 listed)
- incomplete clinical or CT-scan data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
create a physiopathological 3D model of skull deformation for each type of CMTs)
Time frame: 1 day
create a physiopathological 3D model of skull deformation for each type of CMTs)
1 secondary outcome
Characterisation of the skull base asymmetry and cranioverterbral deformation
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Individual participant dataSharing planned: Undecided. NC
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Magali bourgoin contact
Guillaume CAPTIER, MD.PhD study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Torticollis and Positionnel Skull Deformation, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guillaume CAPTIER, MD.PhD (4 67 33 95 81 ext. 33, g-captier@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
create a physiopathological 3D model of skull deformation for each type of CMTs) (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2020.