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

NCT ID: NCT02302534

Last Updated: 2015-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-06-30

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

patients

2 groups with MRI :

• 8 right thoracic AIS participants (Cobb angle between 20 and 40°)

Group Type: EXPERIMENTAL

MRI

Intervention Type: DEVICE

MRI

controls subjects

\- 8 healthy controls (no clinical scoliosis)

Group Type: EXPERIMENTAL

MRI

Intervention Type: DEVICE

MRI

Interventions

MRI

MRI

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Tours

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Edouard LORET, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Tours

Locations

University Hospital of Tours

Tours, , France

Countries

France

Other Identifiers

PHAO 2014 - JEL / MOR-FO-SIA

Identifier Type: -

Identifier Source: org_study_id