Clinical trial NCT02302534: Pilot Study of Functional and Morphometric Brain Abnormalities Related to Adolescent Idiopathic Scoliosis (MOR-FO-SIA)
Official title: Pilot Study of Functional and Morphometric Brain Abnormalities Related to Adolescent Idiopathic Scoliosis (MOR-FO-SIA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Idiopathic Scoliosis
Keywords: scoliosis
MRI (Magnetic Resonance Imaging)
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2014-11-27
Enrollment: 16
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Adolescent idiopathic scoliosis (AIS) is a complex deformity with different curves. These different curves may be distinguished by different physiopathologic mechanisms.

Without fully convincing model of the emergence and development of AIS, their multifactorial nature seems evident. Several pathophysiological theories involving the central nervous system have been proposed: the AIS would be associated with disturbances of proprioceptive or sensory perception, and/or with integration of this information. This would result in an abnormal body image, responsible for sensorimotor asymmetry that may promote or cause the deformation.

The Main aim of this study is to find cortical and subcortical morphometric differences in the most common population of AIS (right thoracic AIS) compared to healthy adolescent control girls.

Secondary Objectives are to study the cerebral white matter of the same groups (fractional anisotropy in the main white matter tracts), and activation of sensorimotor neural networks (fMRI activation and functional brain connectivity).

Abnormalities of the studied parameters may be used as biomarkers for AIS diagnosis and classification.


Eligibility criteria: Inclusion Criteria:

* female
* between 14 and 16 years old
* normal neurological examination
* right handed
* informed consent
* informed consent form signed by a parent or a holder of parental authority
* affiliated to medical insurance
* negative urine pregnancy test For patients (A-STD) : right thoracic scoliosis with a Cobb angle between 20 and 40° For healthy volunteers (A-N) : no clinical scoliosis

Exclusion Criteria:

* pregnant or lactating woman
* antecedents of cranial trauma or cranial intervention, of migraine, of spinal trauma, of scoliosis intervention
* no idiopathic scoliosis
* contraindications to MRI
* patient with a legal protection measure

Primary outcomes:
measure: Variation in regional cortical and subcortical volume, as measured by MRI
timeFrame: One day
Secondary outcomes:
measure: Variation in fractional anisotropy in the main white matter tracts, as measured by MRI
timeFrame: one day
measure: Variation in activation of sensorimotor neural networks, as measured by MRI
timeFrame: one day
Other outcomes:
Locations:
city: Tours
country: France
facility: University Hospital of Tours
Study officials:
affiliation: University Hospital of Tours
name: Jean-Edouard LORET, MD
role: PRINCIPAL_INVESTIGATOR
References: