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

NCT07135765 | Recruiting

• 2 other identifiers: APHP2417262024-A02677-40
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Scoliosis; Scoliosis Idiopathic; Scoliosis Neuromuscular

Keywords

scoliosis; MRI; Scoliosis Idiopathic; Scoliosis Neuromuscular; spine; Children

Outcome Measures

Primary Outcomes (7)

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

  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.

  at baseline

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

  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.

  at baseline

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

  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.

  at baseline

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

  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.

  at baseline

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

  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.

  at baseline

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

  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.

  at baseline

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

  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.

  at baseline

Study Arms (2)

idiopathic scoliosis (IS)

ACTIVE COMPARATOR

Procedure: Additional 5 minutes of lying down position during MRI

neuromuscular scoliosis (NMS)

ACTIVE COMPARATOR

Procedure: Additional 5 minutes of lying down position during MRI

Interventions

Additional 5 minutes of lying down position during MRI PROCEDURE

During axial MRI for scoliosis assessment, additional 5 minutes of lying down position in order to performing a specific sequence for the study of the vertebral muscles (Diffusion Tensor Imaging).

idiopathic scoliosis (IS); neuromuscular scoliosis (NMS)

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

CHU Raymond Poincaré - APHP

Garches, 92380, France

RECRUITING

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Hélène Gouz, MD

  CHU Raymond Poincaré - APHP

  PRINCIPAL INVESTIGATOR

• Robert Carlier, MD, PhD

  CHU Raymond Poincaré - APHP

  STUDY DIRECTOR

Central Study Contacts

Hélène Gouz, MD

CONTACT

+33149094674; helene.gouze@aphp.fr

Marie-Line PISSONNIER, MD, PhD

CONTACT

+33 671612829; ml.pissonnier@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: August 22, 2025
• Study Start: July 17, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: August 22, 2025

Record last verified: 2025-07

Locations

FR (1)