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Completed

NCT Number: NCT02302534

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

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.

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Key information

Conditions

Adolescent Idiopathic Scoliosis Bone Diseases Musculoskeletal Diseases Scoliosis Spinal Curvatures Spinal Diseases

Age range

14 year–16 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Tours

Tours, 37000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI

Device

MRI

Primary outcomes

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

    Time frame: One day

Secondary outcomes

  1. Variation in fractional anisotropy in the main white matter tracts, as measured by MRI

    Time frame: one day

  2. Variation in activation of sensorimotor neural networks, as measured by MRI

    Time frame: one day

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Acronym: MOR-FO-SIA

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 27, 2014
Registry last updated
Sep 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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