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Starting soon Not applicable

Investigating Proprioceptive Impairment in Adolescents With Idiopathic Scoliosis (AIS) (SCOLIO-PROPRIO)

NCT07208929 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2025-10
Last updated
2025-10-06

Condition(s) studied

Scoliosis Idiopathic Adolescent

Investigational drug(s) / intervention(s)

MRI

MRI: Brain and Spinal Cord MRI

Study summary

The goal of this interventionnal study is to learn if teenagers who have severe scoliosis (a curvature of the spine) have trouble sensing their body's position in space (this sense is called proprioception), which are directly linked to abnormalities in the part of the brain that controls movement and/or caused by the muscles on each side of the spine not being the same size or not developing in the same way.

The main question the investigators aim to answer are :

* Do adolescents with severe scoliosis have problems with their sense of body position (proprioception)?
* If so, are these proprioceptive issues linked to specific problems in the part of the brain that controls movement?
* Are these proprioceptive issues also possibly linked to an uneven muscle structure on either side of the spinal curve?

Researchers will compare the part of the brain that controls movement (ensorimotor brain network) of healthy subjects to that of the participants that will enroll in this study.

Participants will only have to do one more MRI that is not included in the routine of clinical management of scoliosis before surgery.

Data will also be retrieved from clinical practice Participants will answer questionnaires after the day of the surgery

Eligibility

Sex
ALL
Min age
10 Years
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria: * Adolescents diagnosed with Adolescent Idiopathic Scoliosis (AIS) and followed in the pediatric orthopedic surgery department, scheduled to undergo spinal fusion surgery (arthrodesis) * No history or clinical signs of neurological disorders * Aged between 10 and 18 years * Written informed consent obtained from both the adolescent and their legal guardians (parents) * Control Group only: Participants will be selected from open-access neuroimaging databases, matched to the patient group by age and sex. Exclusion Criteria: * Presence of any other clinically significant condition that could be associated with spinal deformity * Insufficient proficiency in French to understand the informed consent form * Current treatment with psychotropic medication * Ongoing pregnancy or breastfeeding * Subject under legal or judicial supervision * Contraindications to brain MRI (including: pacemaker; electrically, magnetically, or mechanically activated implants; surgical clips; metallic sutures; staples; etc. - see MRI safety questionnaire annex) * Subject or their parent(s)/legal guardian(s) refuse to be informed of incidental findings detected during MRI * Claustrophobia

Primary outcome measure(s)

  • Correlation between scoliosis and structural brain alteration as assed by dynamic proprioception test and MRI — One day before surgery
    Values of fractional anisotropy (FA) in the corpus callosum and interhemispheric tracts connecting the somatosensory and motor cortices will be compared between the 2 groups of participants \- The differences found between the two groups (patients versus control) will be correlated to the proprioceptive performances in the patient group as assed by motion illusion amplitude index

Trial sites (1)

FacilityCityRegionStatus
Assistance Publique Hôpitaux de Marseille Marseille France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07208929 on ClinicalTrials.gov ↗ ← All trials in France