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

NCT02302534 | Completed

• 1 other identifier: PHAO 2014 - JEL / MOR-FO-SIA
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Adolescent Idiopathic Scoliosis

Keywords

scoliosis; MRI (Magnetic Resonance Imaging)

Outcome Measures

Primary Outcomes (1)

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

  One day

Secondary Outcomes (2)

• 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 Arms (2)

patients

EXPERIMENTAL

2 groups with MRI : \- 8 right thoracic AIS participants (Cobb angle between 20 and 40°)

Device: MRI

controls subjects

EXPERIMENTAL

\- 8 healthy controls (no clinical scoliosis)

Device: MRI

Interventions

MRI DEVICE

MRI

controls subjects; patients

Eligibility Criteria

• Age: 14 Years - 16 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (1)

University Hospital of Tours

Tours, 37000, France

Location

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Jean-Edouard LORET, MD

  University Hospital of Tours

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2014
• First Posted: November 27, 2014
• Study Start: September 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: September 1, 2015

Record last verified: 2015-08

Locations

FR (1)