Evaluation of Cerebrospinal Fluid Flow in Adolescent Idiopathic Scoliosis

Adolescent Idiopathic Scoliosis Clinical Trial

— MEDULLOSCOL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04760808
• Other study ID #: RC-P0093
• Status: Recruiting
• Start date: February 1, 2021
• Est. completion date: July 2023

Study information

• Verified date: January 2022
• Source: Lille Catholic University
• Contact: Amélie LANSIAUX, MD, PhD
• Phone: +33320225269
• Email: lansiaux.amelie[@]ghicl.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: July 2023
• Est. primary completion date: November 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Idiopathic Scoliosis
• Scoliosis

Intervention

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

Locations

Country	Name	City	State
France	GHICL Hôpital Saint Philibert, service d'Imagerie Médicale	Lomme	Nord
France	SSR Pédiatrique Marc Sautelet	Villeneuve-d'Ascq	Nord (59)

Sponsors (2)

Lead Sponsor	Collaborator
Lille Catholic University	SSR pédiatrique Marc Sautelet

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CSF flow (cm/s) at the 7th thoracic vertebra (T7)	The flow will be measured by MRI	6 months
Secondary	CSF flow (cm/s) at the cervico-occipital junction	The flow will be measured by MRI	6 months
Secondary	CSF flow (cm/s) at the cerebral aqueduct	The flow will be measured by MRI	6 months
Secondary	Prevalence of spinal cord abnormalities	Measured by MRI	6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Angle of thoracic kyphosis T4-T12 in degrees	The measurement of radiographic parameters will be done with the EOS system.	6 months
Secondary	Lumbar lordosis angle L1-L5 in degrees	The measurement of radiographic parameters will be done with the EOS system.	6 months
Secondary	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
Secondary	Pelvic incidence in degrees	The measurement of radiographic parameters will be done with the EOS system	6 months
Secondary	Subjective Postural Vertical Measurement in degrees		6 months
Secondary	Subjective Visual Vertical Sight Measurement in degrees		6 months
Secondary	Proprioception Measurement in degrees	Proprioception measurement obtained by trunk repositioning error test (Formetric system)	6 months