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Evaluation of Cerebrospinal Fluid Flow in Adolescent Idiopathic Scoliosis

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04760808
Acronym
MEDULLOSCOL
Enrollment
72
Registered
2021-02-18
Start date
2021-02-10
Completion date
2022-05-04
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent Idiopathic Scoliosis

Keywords

cerebrospinal fluid flow, MRI, Graviception, Postural control

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.

Interventions

Evaluations of Postural control; Subjective postural vertical; Subjective visual vertical; Verticality perception

RADIATIONInitial 3T MRI of the Brain and Spine

Non-injected CSF flow MRI

DIAGNOSTIC_TEST6-month Follow-up Clinical Examination

Evaluations of Postural control; Subjective postural vertical; Subjective visual vertical; Verticality perception

RADIATION6-month Follow-up 3T MRI of the Brain and Spine

Non-injected CSF flow MRI

Sponsors

SSR pédiatrique Marc Sautelet
CollaboratorUNKNOWN
Lille Catholic University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
12 Years to 17 Years
Healthy volunteers
Yes

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
CSF flow (cm/s) at the 7th thoracic vertebra (T7)6 monthsThe flow will be measured by MRI

Secondary

MeasureTime frameDescription
CSF flow (cm/s) at the cerebral aqueduct6 monthsThe flow will be measured by MRI
Prevalence of spinal cord abnormalities6 monthsMeasured by MRI
Correlation between the Body Mass Index and the CSF flow (cm/s) at the 7th thoracic vertebra (T7)6 monthsThis association will be studied by a linear regression analysis
Cobb frontal angle in degrees6 monthThe 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 degrees6 monthsThe measurement of radiographic parameters will be done with the EOS system.
CSF flow (cm/s) at the cervico-occipital junction6 monthsThe flow will be measured by MRI
Lumbo-sacral angle L5-S1 in degrees6 monthsThe 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 degrees6 monthsThe measurement of radiographic parameters will be done with the EOS system
Subjective Postural Vertical Measurement in degrees6 months
Subjective Visual Vertical Sight Measurement in degrees6 months
Proprioception Measurement in degrees6 monthsProprioception measurement obtained by trunk repositioning error test (Formetric system)
Lumbar lordosis angle L1-L5 in degrees6 monthsThe measurement of radiographic parameters will be done with the EOS system.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026