Evaluation of Cerebrospinal Fluid Flow in Adolescent Idiopathic Scoliosis (MEDULLOSCOL)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Adolescent Idiopathic Scoliosis
• Intervention / Treatment: 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

• Study Type: Observational
• Enrollment (Anticipated): 70

Contacts and Locations

• Study Contact: Name: Amélie LANSIAUX, Md, PhD; Phone Number: +33320225269; Email: lansiaux.amelie@ghicl.net
• Study Contact Backup: Name: Mélody Plets; Phone Number: +33320225733; Email: Plets.Melody@ghicl.net

Study Locations

• France
  • Nord
    • Lomme, Nord, France, 59462
      • Active, not recruiting
      • GHICL Hôpital Saint Philibert, service d'Imagerie Médicale
  • Nord (59)
    • Villeneuve-d'Ascq, Nord (59), France, 59650
      • Recruiting
      • SSR Pédiatrique Marc Sautelet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

2 Groups:

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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
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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Lille Catholic University
• Collaborators: SSR pédiatrique Marc Sautelet
• Investigators: Principal Investigator: Jean-François CATANZARITI, MD, SSR Marc Sautelet, France

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: February 16, 2021
• First Submitted That Met QC Criteria: February 16, 2021
• First Posted (Actual): February 18, 2021

Study Record Updates

• Last Update Posted (Actual): January 14, 2022
• Last Update Submitted That Met QC Criteria: January 12, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: MRI; Postural control; cerebrospinal fluid flow; Graviception
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: RC-P0093

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No