- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02302534
Pilot Study of Functional and Morphometric Brain Abnormalities Related to Adolescent Idiopathic Scoliosis (MOR-FO-SIA) (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.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Tours, France, 37000
- University Hospital of Tours
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: patients
2 groups with MRI : - 8 right thoracic AIS participants (Cobb angle between 20 and 40°) |
MRI
|
Experimental: controls subjects
- 8 healthy controls (no clinical scoliosis)
|
MRI
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Variation in regional cortical and subcortical volume, as measured by MRI
Time Frame: One day
|
One day
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Variation in fractional anisotropy in the main white matter tracts, as measured by MRI
Time Frame: one day
|
one day
|
Variation in activation of sensorimotor neural networks, as measured by MRI
Time Frame: one day
|
one day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jean-Edouard LORET, MD, University Hospital of Tours
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PHAO 2014 - JEL / MOR-FO-SIA
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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