Evaluation of Cerebrospinal Fluid Flow in Adolescent Idiopathic Scoliosis

NCT ID: NCT04760808

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 72 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-10
• Study Completion Date: 2022-05-04

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.

Conditions

Adolescent Idiopathic Scoliosis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

AIS group

Baseline Clinical Examination

Intervention Type: DIAGNOSTIC_TEST

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

Initial 3T MRI of the Brain and Spine

Intervention Type: RADIATION

Non-injected CSF flow MRI

6-month Follow-up Clinical Examination

Intervention Type: DIAGNOSTIC_TEST

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

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

Intervention Type: RADIATION

Non-injected CSF flow MRI

Control Group

Baseline Clinical Examination

Intervention Type: DIAGNOSTIC_TEST

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

Initial 3T MRI of the Brain and Spine

Intervention Type: RADIATION

Non-injected CSF flow MRI

Interventions

Baseline Clinical Examination

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

Intervention Type: DIAGNOSTIC_TEST

Initial 3T MRI of the Brain and Spine

Non-injected CSF flow MRI

Intervention Type: RADIATION

6-month Follow-up Clinical Examination

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

Intervention Type: DIAGNOSTIC_TEST

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

Non-injected CSF flow MRI

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• 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

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

SSR pédiatrique Marc Sautelet

UNKNOWN

Sponsor Role: collaborator

Lille Catholic University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-François CATANZARITI, MD

Role: PRINCIPAL_INVESTIGATOR

SSR Marc Sautelet, France

Locations

SSR Pédiatrique Marc Sautelet

Villeneuve-d'Ascq, Nord (59), France

GHICL Hôpital Saint Philibert, service d'Imagerie Médicale

Lomme, Nord, France

Countries

France

Other Identifiers

RC-P0093

Identifier Type: -

Identifier Source: org_study_id