Pilot Study of Functional and Morphometric Brain Abnormalities Related to Adolescent Idiopathic Scoliosis (MOR-FO-SIA)

Adolescent Idiopathic Scoliosis Clinical Trial

— MOR-FO-SIA  

Official title:

Pilot Study of Functional and Morphometric Brain Abnormalities Related to Adolescent Idiopathic Scoliosis (MOR-FO-SIA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02302534
• Other study ID #: PHAO 2014 - JEL / MOR-FO-SIA
• Status: Completed
• Phase: N/A
• First received: October 21, 2014
• Last updated: August 31, 2015
• Start date: September 2014
• Est. completion date: June 2015

Study information

• Verified date: August 2015
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 16 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Adolescent Idiopathic Scoliosis
• Scoliosis

Intervention

Device:
• MRI
MRI

Locations

Country	Name	City	State
France	University Hospital of Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variation in regional cortical and subcortical volume, as measured by MRI		One day	No
Secondary	Variation in fractional anisotropy in the main white matter tracts, as measured by MRI		one day	No
Secondary	Variation in activation of sensorimotor neural networks, as measured by MRI		one day	No