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

Primary Purpose

Adolescent Idiopathic Scoliosis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI
Sponsored by
University Hospital, Tours
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Adolescent Idiopathic Scoliosis focused on measuring scoliosis, MRI (Magnetic Resonance Imaging)

Eligibility Criteria

14 Years - 16 Years (Child)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University Hospital of Tours

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

patients

controls subjects

Arm Description

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

- 8 healthy controls (no clinical scoliosis)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Variation in fractional anisotropy in the main white matter tracts, as measured by MRI
Variation in activation of sensorimotor neural networks, as measured by MRI

Full Information

First Posted
October 21, 2014
Last Updated
August 31, 2015
Sponsor
University Hospital, Tours
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1. Study Identification

Unique Protocol Identification Number
NCT02302534
Brief Title
Pilot Study of Functional and Morphometric Brain Abnormalities Related to Adolescent Idiopathic Scoliosis (MOR-FO-SIA)
Acronym
MOR-FO-SIA
Official Title
Pilot Study of Functional and Morphometric Brain Abnormalities Related to Adolescent Idiopathic Scoliosis (MOR-FO-SIA)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Tours

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Idiopathic Scoliosis
Keywords
scoliosis, MRI (Magnetic Resonance Imaging)

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patients
Arm Type
Experimental
Arm Description
2 groups with MRI : - 8 right thoracic AIS participants (Cobb angle between 20 and 40°)
Arm Title
controls subjects
Arm Type
Experimental
Arm Description
- 8 healthy controls (no clinical scoliosis)
Intervention Type
Device
Intervention Name(s)
MRI
Intervention Description
MRI
Primary Outcome Measure Information:
Title
Variation in regional cortical and subcortical volume, as measured by MRI
Time Frame
One day
Secondary Outcome Measure Information:
Title
Variation in fractional anisotropy in the main white matter tracts, as measured by MRI
Time Frame
one day
Title
Variation in activation of sensorimotor neural networks, as measured by MRI
Time Frame
one day

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Edouard LORET, MD
Organizational Affiliation
University Hospital of Tours
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Tours
City
Tours
ZIP/Postal Code
37000
Country
France

12. IPD Sharing Statement

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

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