Evaluation of Cerebrospinal Fluid Flow in Adolescent Idiopathic Scoliosis

NCT04760808 | Completed

• 1 other identifier: RC-P0093
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 2

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

Keywords

cerebrospinal fluid flow; MRI; Graviception; Postural control

Outcome Measures

Primary Outcomes (1)

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

  The flow will be measured by MRI

  6 months

Secondary Outcomes (13)

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

  6 months

• CSF flow (cm/s) at the cerebral aqueduct

  6 months

• Prevalence of spinal cord abnormalities

  6 months

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

  6 months

• Cobb frontal angle in degrees

  6 month

Study Arms (2)

AIS group

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

Control Group

Diagnostic Test: Baseline Clinical Examination; Radiation: Initial 3T MRI of the Brain and Spine

Interventions

Baseline Clinical Examination DIAGNOSTIC_TEST

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

AIS group; Control Group

Initial 3T MRI of the Brain and Spine RADIATION

Non-injected CSF flow MRI

AIS group; Control Group

6-month Follow-up Clinical Examination DIAGNOSTIC_TEST

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

AIS group

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

Non-injected CSF flow MRI

AIS group

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

2 Groups: * 35 cases: Female Adolescents with AIS * 35 controls: Female subjects without scoliosis

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Lille Catholic University: lead
• SSR pédiatrique Marc Sautelet: collaborator

Study Sites (2)

SSR Pédiatrique Marc Sautelet

Villeneuve-d'Ascq, Nord (59), 59650, France

Location

GHICL Hôpital Saint Philibert, service d'Imagerie Médicale

Lomme, Nord, 59462, France

Location

Study Officials

• Jean-François CATANZARITI, MD

  SSR Marc Sautelet, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2021
• First Posted: February 18, 2021
• Study Start: February 10, 2021
• Primary Completion: May 4, 2022
• Study Completion: May 4, 2022
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)