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临床试验/NCT07135765
NCT07135765招募中不适用

Paravertebral Muscles Assessment Using High-resolution MRI in Children Suffering From Idiopathic or Neuromuscular Scoliosis

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2025年7月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
10
试验地点
1
主要终点
Muscular parameters defined in areas of specific interest and studied in the concavity and convexity of the main curvature: Cross-sectional area

研究概览

简要总结

Scoliosis is a common three-dimensional spinal deformity defined by vertebral rotation.

Apart from collapse scoliosis, clinical and radiological similarities have been observed in children with secondary scoliosis of neuromuscular origin and children with idiopathic scoliosis in terms of the location and type of curvature.

It seems relevant to study the axial musculature in these children in more detail, particularly the deep muscles (transversospinales muscles) that have a stabilising and rotational function (multifidi and rotatores).

MRI is a non-invasive, non-irradiating technique used in the aetiological diagnosis of idiopathic scoliosis before adolescence and in the diagnosis of secondary scoliosis. However, the muscles are not specifically studied during these examinations. They are performed to analyse the spinal cord and rule out hinge deformities, although this technique does provide information on the paravertebral muscles.

The muscles of interest should be analysed using the usual sequences, with the addition of a sequence (DTI) specific to the study of deep muscles in children undergoing axial MRI. This adds 5 minutes to the standard MRI procedure.

Several morphological muscle parameters would be thus obtained on specific interest areas and then compared between right and left side and between two groups of children, 5 suffering from idiopathic scoliosis and 5 with neuromuscular scoliosis.

Idiopathic scoliosis corresponds to a heterogeneous group of patients in terms of the location, number and progression of the curves. The research hypothesis is that there may be a subgroup of patients with idiopathic scoliosis whose progression and/or aetiology is muscular in origin.

MRI could then become a routine examination in the assessment of all scoliosis, whether idiopathic or not.

详细描述

This study is based on the hypothesis that there is a subgroup of patients with idiopathic scoliosis whose onset and/or progression is linked to muscle dysfunction.

This is a prospective, comparative, non-randomised study without a control group, performed in a single centre (Garches Hospital in France is a reference centre for neuromuscular diseases and disabilities). This research is in the field of data collection techniques using imaging methods on two populations of children with scoliosis.

OBJECTIVES The primary objective is the assessment of morphological differences in paravertebral muscles between children with scoliosis of different origins (idiopathic (IS) or neuromuscular (NMS))

Secondary objectives are:

  • Assessment of morphological differences between the paravertebral muscles of the convexity and concavity in idiopathic scoliosis
  • Assessment of morphological differences between the paravertebral muscles of the convexity and concavity in neuromuscular scoliosis; RESEARCH PROCESS

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
10 Years 至 17 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Children and adolescents aged 10 to 17 years old,
  • •Scoliosis (idiopathic or neuromuscular) that is not collapsing
  • •Cobb angle <40°
  • •Female preferred
  • •Patient able to walk
  • •Average or low BMI <20kg/m2
  • •Signature of informed consent by legal guardians
  • •Affiliation with a social security scheme (beneficiary or dependent).

排除标准

  • •Refusal of the patient and/or parents to participate in the study
  • •Inability to cooperate
  • •Subject with a contraindication to MRI
  • •History of spinal surgery
  • •Not affiliated with a social security scheme (beneficiary or entitled person)

研究组 & 干预措施

idiopathic scoliosis (IS)

Active Comparator

干预措施: Additional 5 minutes of lying down position during MRI (Procedure)

neuromuscular scoliosis (NMS)

Active Comparator

干预措施: Additional 5 minutes of lying down position during MRI (Procedure)

结局指标

主要结局

Muscular parameters defined in areas of specific interest and studied in the concavity and convexity of the main curvature: Cross-sectional area

时间窗: at baseline

Analysis of differences in several morphological muscle parameters obtained from MRI scans between children with scoliosis (SI versus SNM). - Cross-sectional area The parameter will be defined in areas of specific interest at the transitional vertebrae and apical vertebrae and will be studied in the concavity and convexity.

Muscular parameters defined in areas of specific interest and studied in the concavity and convexity of the main curvature: T2 value

时间窗: at baseline

Analysis of differences in several morphological muscle parameters obtained from MRI scans between children with scoliosis (SI versus SNM). - T2 value These parameters will be defined in areas of specific interest at the transitional vertebrae and apical vertebrae and will be studied in the concavity and convexity.

Muscular parameters defined in areas of specific interest and studied in the concavity and convexity of the main curvature: Pennation angle

时间窗: at baseline

Analysis of differences in several morphological muscle parameters obtained from MRI scans between children with scoliosis (SI versus SNM). - Pennation angle The parameter will be defined in areas of specific interest at the transitional vertebrae and apical vertebrae and will be studied in the concavity and convexity.

Muscular parameters defined in areas of specific interest and studied in the concavity and convexity of the main curvature: Number of muscle fibres

时间窗: at baseline

Analysis of differences in several morphological muscle parameters obtained from MRI scans between children with scoliosis (SI versus SNM). - Number of muscle fibres The parameter will be defined in areas of specific interest at the transitional vertebrae and apical vertebrae and will be studied in the concavity and convexity.

Muscular parameters defined in areas of specific interest and studied in the concavity and convexity of the main curvature: T1 value

时间窗: at baseline

Analysis of differences in several morphological muscle parameters obtained from MRI scans between children with scoliosis (SI versus SNM). - T1 value The parameter will be defined in areas of specific interest at the transitional vertebrae and apical vertebrae and will be studied in the concavity and convexity.

Muscular parameters defined in areas of specific interest and studied in the concavity and convexity of the main curvature: Anisotropy fraction value

时间窗: at baseline

Analysis of differences in several morphological muscle parameters obtained from MRI scans between children with scoliosis (SI versus SNM). - Anisotropy fraction value These parameters will be defined in areas of specific interest at the transitional vertebrae and apical vertebrae and will be studied in the concavity and convexity.

Muscular parameters defined in areas of specific interest and studied in the concavity and convexity of the main curvature: Diffusivity value

时间窗: at baseline

Analysis of differences in several morphological muscle parameters obtained from MRI scans between children with scoliosis (SI versus SNM). - Diffusivity value (average, radial, axial) These parameters will be defined in areas of specific interest at the transitional vertebrae and apical vertebrae and will be studied in the concavity and convexity.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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