CompletedNot Applicable

Evaluation of Cerebrospinal Fluid Flow in Adolescent Idiopathic Scoliosis

France72 participantsStarted 2021-02-10

Plain-language 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.

Who can participate

Age range

12 Years – 17 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 neur…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 6 months

Trial details

NCT IDNCT04760808

SponsorLille Catholic University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-05-04

View on ClinicalTrials.gov More Adolescent Idiopathic Scoliosis trials