Clinical trial NCT04760808: Evaluation of Cerebrospinal Fluid Flow in Adolescent Idiopathic Scoliosis
Official title: Evaluation of Cerebrospinal Fluid Flow by MRI in Adolescent Idiopathic Scoliosis, From Its Signaling Through the Study of Trunk Graviception and Proprioception
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adolescent Idiopathic Scoliosis
Keywords: cerebrospinal fluid flow
MRI
Graviception
Postural control
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
Collaborators: name: SSR pédiatrique Marc Sautelet
First posted: 2021-02-18
Enrollment: 72
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 2 Groups:

* 35 cases: Female Adolescents with AIS
* 35 controls: Female subjects without scoliosis

Brief summary: Adolescent Idiopathic Scoliosis (AIS) is the most frequent spinal deformity in adolescence, but its etiology remains unknown. Recent publications suggest a link between ciliopathy and AIS. More specifically a modification of the cerebro-spinal fluid (CSF) flow by ciliary dysfunction could be at the origin of a scoliotic deformity.

This study aims to compare the CSF flow measured by magnetic resonance imaging (MRI) in an AIS group and a control group.


Eligibility criteria: Common Inclusion Criteria for the 2 groups :

* Female subject aged 12 to \< 18 years old
* Affiliated to the French social security system
* Having signed the inform consent form
* Whose parents have given their consent

Additional Inclusion Criteria for the AIS group:

* Subject with right thoracic AIS defined by the existence of a 3D spine deformation with a frontal deviation to right dorsal convexity with a Cobb angle of at least 20°, and a rotation of at least 20°, as evidenced by the presence of a vertebral gibbosity ≥ 5° at the Bunnel scoliometer.

If the scoliosis has more than one curvature, the right chest curvature should be the greatest high (highest frontal Cobb angle)

* Subject with x-rays of total spine, face and profile under load, according to the EOS technique, dating from less than 3 months.

Common Exclusion Criteria for the 2 groups:

* Instability to submit to the medical follow-up of the study for psychic, social or geographical reasons
* At least 6 "cafe au lait" spots with a size ≥ 1.5 cm (may be suggestive of neurofibromatosis)
* Ligament hyperlaxity confirmed by a Beighton score \>4/9 (which may be suggestive of scoliosis secondary)
* Contraindications of a cerebro-medullary MRI: claustrophobia, foreign bodies, and ferrometallic clips of the trunk or cephalic segment, cochlear implants, stimulators and implantable cardiac defibrillators, insulin pump
* Inequality in length of the lower limbs ≥ 20 mm on clinical examination
* Subject presenting neurological signs (signs of pyramidal irritation, sensory-motor deficit, clinical signs suggestive of cerebellar pathology ...)
* Known vestibular pathology
* Taking psychotropic drugs

Additional exclusion criterion for the AIS group:

* Subject with secondary scoliosis : neurological, orthopedic, malformative...

Additional criteria for the control group:

* Subject with a scoliosis angle ≥ 10° on a photogrammetric screening assessment (optical process, non-irradiating, which allows an Morphometric evaluation of the trunk in 3D, thanks to the analysis of the trunk reliefs)
* Subject whose clinical examination shows a gibbosity measurable (\>5°) with the scoliometer of Bunnel

Primary outcomes:
measure: CSF flow (cm/s) at the 7th thoracic vertebra (T7)
timeFrame: 6 months
Secondary outcomes:
measure: CSF flow (cm/s) at the cervico-occipital junction
timeFrame: 6 months
measure: CSF flow (cm/s) at the cerebral aqueduct
timeFrame: 6 months
measure: Prevalence of spinal cord abnormalities
timeFrame: 6 months
measure: Correlation between the Body Mass Index and the CSF flow (cm/s) at the 7th thoracic vertebra (T7)
timeFrame: 6 months
measure: Cobb frontal angle in degrees
timeFrame: 6 month
measure: Distance between the vertical line passing through the middle of the sacrum and the vertical line passing through the spine of the 7th cervical vertebra.
timeFrame: 6 month
measure: Angle of thoracic kyphosis T4-T12 in degrees
timeFrame: 6 months
measure: Lumbar lordosis angle L1-L5 in degrees
timeFrame: 6 months
measure: Lumbo-sacral angle L5-S1 in degrees
timeFrame: 6 months
measure: Pelvic incidence in degrees
timeFrame: 6 months
measure: Subjective Postural Vertical Measurement in degrees
timeFrame: 6 months
measure: Subjective Visual Vertical Sight Measurement in degrees
timeFrame: 6 months
measure: Proprioception Measurement in degrees
timeFrame: 6 months
Other outcomes:
Locations:
city: Villeneuve-d'Ascq
country: France
facility: SSR Pédiatrique Marc Sautelet
state: Nord (59)
city: Lomme
country: France
facility: GHICL Hôpital Saint Philibert, service d'Imagerie Médicale
state: Nord
Study officials:
affiliation: SSR Marc Sautelet, France
name: Jean-François CATANZARITI, MD
role: PRINCIPAL_INVESTIGATOR
References: