Evaluation of Cerebrospinal Fluid Flow in Adolescent Idiopathic Scoliosis

• Conditions: Adolescent Idiopathic Scoliosis
• Interventions: 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

• Registration Number: NCT04760808
• Lead Sponsor: Lille Catholic University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-01
• Study First Submitted: 2021-02-16
• Study First Submitted QC: 2021-02-16
• Study First Posted: 2021-02-18
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-12
• Last Update Posted: 2022-01-14
• Primary Completion: 2022-11
• Study Completion: 2023-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
AIS group	Initial 3T MRI of the Brain and Spine	-
AIS group	Baseline Clinical Examination	-
Control Group	Baseline Clinical Examination	-
AIS group	6-month Follow-up Clinical Examination	-
Control Group	Initial 3T MRI of the Brain and Spine	-
AIS group	6-month Follow-up 3T MRI of the Brain and Spine	-

Primary Outcome Measures

Name	Time	Method
CSF flow (cm/s) at the 7th thoracic vertebra (T7)	6 months	The flow will be measured by MRI

Secondary Outcome Measures

Name	Time	Method
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)
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.

Trial Locations

Locations (2)

SSR Pédiatrique Marc Sautelet; 🇫🇷 Villeneuve-d'Ascq, Nord (59), France

GHICL Hôpital Saint Philibert, service d'Imagerie Médicale; 🇫🇷 Lomme, Nord, France