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Completed

NCT Number: NCT04760808

Evaluation of Cerebrospinal Fluid Flow in Adolescent Idiopathic Scoliosis

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.

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Key information

Age range

12 year–17 year

Sex eligibility

Female

Study type

Observational

Primary location

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

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Baseline Clinical Examination

Diagnostic Test

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

Initial 3T MRI of the Brain and Spine

Radiation

Non-injected CSF flow MRI

6-month Follow-up Clinical Examination

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

Radiation

Non-injected CSF flow MRI

Primary outcomes

  1. CSF flow (cm/s) at the 7th thoracic vertebra (T7)

    Time frame: 6 months

    The flow will be measured by MRI

Secondary outcomes

  1. CSF flow (cm/s) at the cervico-occipital junction

    Time frame: 6 months

    The flow will be measured by MRI

  2. CSF flow (cm/s) at the cerebral aqueduct

    Time frame: 6 months

    The flow will be measured by MRI

  3. Prevalence of spinal cord abnormalities

    Time frame: 6 months

    Measured by MRI

  4. Correlation between the Body Mass Index and the CSF flow (cm/s) at the 7th thoracic vertebra (T7)

    Time frame: 6 months

    This association will be studied by a linear regression analysis

  5. Cobb frontal angle in degrees

    Time frame: 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.

  6. 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.

    Time frame: 6 month

  7. Angle of thoracic kyphosis T4-T12 in degrees

    Time frame: 6 months

    The measurement of radiographic parameters will be done with the EOS system.

  8. Lumbar lordosis angle L1-L5 in degrees

    Time frame: 6 months

    The measurement of radiographic parameters will be done with the EOS system.

  9. Lumbo-sacral angle L5-S1 in degrees

    Time frame: 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.

  10. Pelvic incidence in degrees

    Time frame: 6 months

    The measurement of radiographic parameters will be done with the EOS system

  11. Subjective Postural Vertical Measurement in degrees

    Time frame: 6 months

  12. Subjective Visual Vertical Sight Measurement in degrees

    Time frame: 6 months

  13. Proprioception Measurement in degrees

    Time frame: 6 months

    Proprioception measurement obtained by trunk repositioning error test (Formetric system)

Sponsors and collaborators

Lead sponsor

Lille Catholic University

Other

Collaborators

  • SSR pédiatrique Marc Sautelet

Registry information

Official study title

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

Acronym: MEDULLOSCOL

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 18, 2021
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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