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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02302534
Other study ID # PHAO 2014 - JEL / MOR-FO-SIA
Secondary ID
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


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
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