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Clinical Trials/NCT02302534
NCT02302534
Completed
Not Applicable

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

University Hospital, Tours1 site in 1 country16 target enrollmentSeptember 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Adolescent Idiopathic Scoliosis
Sponsor
University Hospital, Tours
Enrollment
16
Locations
1
Primary Endpoint
Variation in regional cortical and subcortical volume, as measured by MRI
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2014
End Date
June 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

Variation in regional cortical and subcortical volume, as measured by MRI

Time Frame: One day

Secondary Outcomes

  • Variation in fractional anisotropy in the main white matter tracts, as measured by MRI(one day)
  • Variation in activation of sensorimotor neural networks, as measured by MRI(one day)

Study Sites (1)

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