MEDULLOSCOL: Evaluation of Cerebrospinal Fluid Flow in Adolescent Idiopathic Scoliosis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| AIS group
|
Diagnostic Test: Baseline Clinical Examination
Evaluations of Postural control; Subjective postural vertical; Subjective visual vertical; Verticality perception
Radiation: Initial 3T MRI of the Brain and Spine
Non-injected CSF flow MRI
Diagnostic Test: 6-month Follow-up Clinical Examination
Evaluations of Postural control; Subjective postural vertical; Subjective visual vertical; Verticality perception
Radiation: 6-month Follow-up 3T MRI of the Brain and Spine
Non-injected CSF flow MRI
|
| Control Group
|
Diagnostic Test: Baseline Clinical Examination
Evaluations of Postural control; Subjective postural vertical; Subjective visual vertical; Verticality perception
Radiation: Initial 3T MRI of the Brain and Spine
Non-injected CSF flow MRI
|
Outcome Measures
Primary Outcome Measures
- CSF flow (cm/s) at the 7th thoracic vertebra (T7) [6 months]
The flow will be measured by MRI
Secondary Outcome Measures
- CSF flow (cm/s) at the cervico-occipital junction [6 months]
The flow will be measured by MRI
- CSF flow (cm/s) at the cerebral aqueduct [6 months]
The flow will be measured by MRI
- Prevalence of spinal cord abnormalities [6 months]
Measured by MRI
- Correlation between the Body Mass Index and the CSF flow (cm/s) at the 7th thoracic vertebra (T7) [6 months]
This association will be studied by a linear regression analysis
- Cobb frontal angle in degrees [6 month]
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.
- 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 [6 months]
The measurement of radiographic parameters will be done with the EOS system.
- Lumbar lordosis angle L1-L5 in degrees [6 months]
The measurement of radiographic parameters will be done with the EOS system.
- Lumbo-sacral angle L5-S1 in degrees [6 months]
The measurement of radiographic parameters will be done with the EOS system The measurement of radiographic parameters will be done with the EOS system.
- Pelvic incidence in degrees [6 months]
The measurement of radiographic parameters will be done with the EOS system
- Subjective Postural Vertical Measurement in degrees [6 months]
- Subjective Visual Vertical Sight Measurement in degrees [6 months]
- Proprioception Measurement in degrees [6 months]
Proprioception measurement obtained by trunk repositioning error test (Formetric system)
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | SSR Pédiatrique Marc Sautelet | Villeneuve-d'Ascq | Nord (59) | France | 59650 |
| 2 | GHICL Hôpital Saint Philibert, service d'Imagerie Médicale | Lomme | Nord | France | 59462 |
Sponsors and Collaborators
- Lille Catholic University
- SSR pédiatrique Marc Sautelet
Investigators
- Principal Investigator: Jean-François CATANZARITI, MD, SSR Marc Sautelet, France
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RC-P0093