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

L

Lille Catholic University

Status

Completed

Conditions

Adolescent Idiopathic Scoliosis

Treatments

Radiation: 6-month Follow-up 3T MRI of the Brain and Spine
Diagnostic Test: Baseline Clinical Examination
Diagnostic Test: 6-month Follow-up Clinical Examination
Radiation: Initial 3T MRI of the Brain and Spine

Study type

Observational

Funder types

Other

Identifiers

NCT04760808
RC-P0093

Details and patient eligibility

About

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.

Enrollment

72 patients

Sex

Female

Ages

12 to 17 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

72 participants in 2 patient groups

AIS group
Treatment:
Radiation: Initial 3T MRI of the Brain and Spine
Diagnostic Test: 6-month Follow-up Clinical Examination
Diagnostic Test: Baseline Clinical Examination
Radiation: 6-month Follow-up 3T MRI of the Brain and Spine
Control Group
Treatment:
Radiation: Initial 3T MRI of the Brain and Spine
Diagnostic Test: Baseline Clinical Examination

Trial contacts and locations

2

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Central trial contact

Mélody Plets; Amélie LANSIAUX, MD, PhD

Data sourced from clinicaltrials.gov

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