Pilot Study of Functional and Morphometric Brain Abnormalities Related to Adolescent Idiopathic Scoliosis (MOR-FO-SIA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Variation in regional cortical and subcortical volume, as measured by MRI
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 16 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Variation in regional cortical and subcortical volume, as measured by MRI
时间窗: One day
次要结局
- 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)