Evaluation of Cerebrospinal Fluid Flow in Adolescent Idiopathic Scoliosis

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Cerebrospinal Fluid Flow by MRI in Adolescent Idiopathic Scoliosis, From Its Signaling Through the Study of Trunk Graviception and Proprioception

Conditions
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Adolescent Idiopathic Scoliosis

Intervention / Treatment
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* Diagnostic Test: Baseline Clinical Examination
* Radiation: Initial 3T MRI of the Brain and Spine
* Diagnostic Test: 6-month Follow-up Clinical Examination
* Radiation: 6-month Follow-up 3T MRI of the Brain and Spine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| AIS group<br> | Diagnostic Test: Baseline Clinical Examination<br>* Evaluations of Postural control; Subjective postural vertical; Subjective visual vertical; Verticality perception<br>Radiation: Initial 3T MRI of the Brain and Spine<br>* Non-injected CSF flow MRI<br>Diagnostic Test: 6-month Follow-up Clinical Examination<br>* Evaluations of Postural control; Subjective postural vertical; Subjective visual vertical; Verticality perception<br>Radiation: 6-month Follow-up 3T MRI of the Brain and Spine<br>* Non-injected CSF flow MRI<br>|
| Control Group<br> | Diagnostic Test: Baseline Clinical Examination<br>* Evaluations of Postural control; Subjective postural vertical; Subjective visual vertical; Verticality perception<br>Radiation: Initial 3T MRI of the Brain and Spine<br>* Non-injected CSF flow MRI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CSF flow (cm/s) at the 7th thoracic vertebra (T7) | The flow will be measured by MRI | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CSF flow (cm/s) at the cervico-occipital junction | The flow will be measured by MRI | 6 months | 
| CSF flow (cm/s) at the cerebral aqueduct | The flow will be measured by MRI | 6 months | 
| Prevalence of spinal cord abnormalities | Measured by MRI | 6 months | 
| Correlation between the Body Mass Index and the CSF flow (cm/s) at the 7th thoracic vertebra (T7) | This association will be studied by a linear regression analysis | 6 months | 
| Cobb frontal angle in degrees | The measurement of radiographic parameters will be done with the EOS system. The EOS system is a new slot-scanning radiological device that allows simultaneous acquisition of frontal and lateral images. It is composed of two X-ray sources, shaped as fan beams through collimation slits. | 6 month | 
| 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. |  | 6 month | 
| Angle of thoracic kyphosis T4-T12 in degrees | The measurement of radiographic parameters will be done with the EOS system. | 6 months | 
| Lumbar lordosis angle L1-L5 in degrees | The measurement of radiographic parameters will be done with the EOS system. | 6 months | 
| Lumbo-sacral angle L5-S1 in degrees | The measurement of radiographic parameters will be done with the EOS system The measurement of radiographic parameters will be done with the EOS system. | 6 months | 
| Pelvic incidence in degrees | The measurement of radiographic parameters will be done with the EOS system | 6 months | 
| Subjective Postural Vertical Measurement in degrees |  | 6 months | 
| Subjective Visual Vertical Sight Measurement in degrees |  | 6 months | 
| Proprioception Measurement in degrees | Proprioception measurement obtained by trunk repositioning error test (Formetric system) | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cerebrospinal fluid flow, Graviception, Postural control, MRI