Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2026-02-20 @ 10:55 PM
Study NCT ID:
NCT02302534
Status:
COMPLETED
Last Update Posted:
2015-09-01
First Post:
2014-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study of Functional and Morphometric Brain Abnormalities Related to Adolescent Idiopathic Scoliosis (MOR-FO-SIA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012600', 'term': 'Scoliosis'}], 'ancestors': [{'id': 'D013121', 'term': 'Spinal Curvatures'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-31', 'studyFirstSubmitDate': '2014-10-21', 'studyFirstSubmitQcDate': '2014-11-26', 'lastUpdatePostDateStruct': {'date': '2015-09-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Variation in regional cortical and subcortical volume, as measured by MRI', 'timeFrame': 'One day'}], 'secondaryOutcomes': [{'measure': 'Variation in fractional anisotropy in the main white matter tracts, as measured by MRI', 'timeFrame': 'one day'}, {'measure': 'Variation in activation of sensorimotor neural networks, as measured by MRI', 'timeFrame': 'one day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['scoliosis', 'MRI (Magnetic Resonance Imaging)'], 'conditions': ['Adolescent Idiopathic Scoliosis']}, 'descriptionModule': {'briefSummary': 'Adolescent idiopathic scoliosis (AIS) is a complex deformity with different curves. These different curves may be distinguished by different physiopathologic mechanisms.\n\nWithout 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.\n\nThe 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.\n\nSecondary 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).\n\nAbnormalities of the studied parameters may be used as biomarkers for AIS diagnosis and classification.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '14 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* female\n* between 14 and 16 years old\n* normal neurological examination\n* right handed\n* informed consent\n* informed consent form signed by a parent or a holder of parental authority\n* affiliated to medical insurance\n* 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\n\nExclusion Criteria:\n\n* pregnant or lactating woman\n* antecedents of cranial trauma or cranial intervention, of migraine, of spinal trauma, of scoliosis intervention\n* no idiopathic scoliosis\n* contraindications to MRI\n* patient with a legal protection measure'}, 'identificationModule': {'nctId': 'NCT02302534', 'acronym': 'MOR-FO-SIA', 'briefTitle': 'Pilot Study of Functional and Morphometric Brain Abnormalities Related to Adolescent Idiopathic Scoliosis (MOR-FO-SIA)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Tours'}, 'officialTitle': 'Pilot Study of Functional and Morphometric Brain Abnormalities Related to Adolescent Idiopathic Scoliosis (MOR-FO-SIA)', 'orgStudyIdInfo': {'id': 'PHAO 2014 - JEL / MOR-FO-SIA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'patients', 'description': '2 groups with MRI :\n\n\\- 8 right thoracic AIS participants (Cobb angle between 20 and 40°)', 'interventionNames': ['Device: MRI']}, {'type': 'EXPERIMENTAL', 'label': 'controls subjects', 'description': '\\- 8 healthy controls (no clinical scoliosis)', 'interventionNames': ['Device: MRI']}], 'interventions': [{'name': 'MRI', 'type': 'DEVICE', 'description': 'MRI', 'armGroupLabels': ['controls subjects', 'patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37000', 'city': 'Tours', 'country': 'France', 'facility': 'University Hospital of Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'overallOfficials': [{'name': 'Jean-Edouard LORET, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Tours'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Tours', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}