ScoliosisMRISCOLNCT07135765
Paravertebral Muscles Assessment Using High-resolution MRI in Idiopathic or Neuromuscular Scoliosis Children
A study testing Additional 5 minutes of lying down position during MRI in people with Scoliosis and Scoliosis Idiopathic, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Scoliosis, Scoliosis Idiopathic, Scoliosis Neuromuscular
- What is being tested?
- Additional 5 minutes of lying down position during MRI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jul 2025to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Raymond Poincaré - APHP
Garches, 92380
About this study
Official title: Paravertebral Muscles Assessment Using High-resolution MRI in Children Suffering From Idiopathic or Neuromuscular Scoliosis
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.
Read more
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.
Read the detailed description
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
- Selection/Information The selection visit takes place during a routine consultation for the diagnosis/monitoring of scoliosis. Children with idiopathic or neuromuscular scoliosis who, as part of their treatment, need to undergo an axial MRI (spinal cord, pan spinal) and who meet the inclusion criteria could be enrolled. Children eligible for the study and their parents, if present, will be offered the opportunity to participate in this study by the investigating physician and will be given the study information sheet.
- Inclusion Inclusion is achieved after a minimum reflection period of 48 hours, and no later than the time of the MRI. After obtaining the child's consent and the signature of a parent or guardian, the child will be included in the study. They will undergo the MRI scan initially prescribed. If conditions allow, they will be asked to remain still for another 5 minutes while the additional sequence is performed. The CAPAS-Q questionnaire (2022 version) will be used to assess physical activity and sedentary behaviour and will be given to the child/adolescent by the investigator to complete. Help will be provided to younger children and children with reading difficulties. The questionnaire will be collected at the end of the visit after it has been completed by the patient.
- Data collection and analysis Imaging data will be pseudonymised, collected and analysed with Olea medical Software( olea-medical.com).
Three regions will be defined:
- Region 1 corresponding to the proximal transitional vertebra
- Region 2 corresponding to the apical vertebra (or disc)
- Region 3 corresponding to the distal transitional vertebra These will then be divided into two zones according to the convexity and concavity of the curvature.
- Region 1 convex / Region 1 concave
- Region 2 convex / Region 2 concave
- Region 3 convex / Region 3 concave
Thus, six regions will be defined and seven parameters per region established, i.e. 42 measurements per MRI:
- Cross-sectional area
- Pennation angle
- Number of muscle fibres
- T1 value
- T2 value
- Anisotropy fraction value
- Diffusivity value (average, radial, axial)
Statistical analysis will be descriptive (prospective descriptive study). Quantitative variables will be described by the mean, standard deviation, median and interquartile range.
Qualitative variables will be described by the number of cases and frequency.
Comparisons will be made between the two groups of children with scoliosis according to the aetiology of the scoliosis.
For each of these parameters, non-parametric tests (Wilcoxon, Mann-Whitney) will be performed.
A p-value < 0.05 will be considered significant. No significant difference will be sought between the two groups of children with scoliosis for each parameter, in order to verify the matching of the groups.
- Age
- Gender
- BMI
- CAPAS-Q score (activity and sedentary lifestyle)
- Cobb angle value;
- Conditions
- Scoliosis, Scoliosis Idiopathic, Scoliosis Neuromuscular
- Being tested
- Additional 5 minutes of lying down position during MRI
- Keywords
- scoliosis, MRI, Scoliosis Idiopathic, Scoliosis Neuromuscular, spine, Children
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional 5 minutes of lying down position during MRIProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| idiopathic scoliosis (IS) | Active comparator | Not described Receives: Procedure: Additional 5 minutes of lying down position during MRI |
| neuromuscular scoliosis (NMS) | Active comparator | Not described Receives: Procedure: Additional 5 minutes of lying down position during MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start17 Jul 2025
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScoliosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hélène Gouz, MD, Principal investigator, CHU Raymond Poincaré - APHPRobert Carlier, MD, PhD, Study director, CHU Raymond Poincaré - APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07135765
- Sponsor's protocol ID
- APHP241726
- Other IDs
- 2024-A02677-40
- Acronym
- MRISCOL
- Status last verified
- Jul 2025
- First submitted
- 15 Jul 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paravertebral Muscles Assessment Using High-resolution MRI in Children Suffering From Idiopathic or Neuromuscular Scoliosis
- ClinicalTrials.gov ID
- NCT07135765
- Acronym / sponsor ID
- MRISCOL / APHP241726
- Conditions
- Scoliosis, Scoliosis Idiopathic, Scoliosis Neuromuscular
- Keywords
- scoliosis, MRI, Scoliosis Idiopathic, Scoliosis Neuromuscular, spine, Children
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 17 Jul 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
- Selection/Information The selection visit takes place during a routine consultation for the diagnosis/monitoring of scoliosis. Children with idiopathic or neuromuscular scoliosis who, as part of their treatment, need to undergo an axial MRI (spinal cord, pan spinal) and who meet the inclusion criteria could be enrolled. Children eligible for the study and their parents, if present, will be offered the opportunity to participate in this study by the investigating physician and will be given the study information sheet.
- Inclusion Inclusion is achieved after a minimum reflection period of 48 hours, and no later than the time of the MRI. After obtaining the child's consent and the signature of a parent or guardian, the child will be included in the study. They will undergo the MRI scan initially prescribed. If conditions allow, they will be asked to remain still for another 5 minutes while the additional sequence is performed. The CAPAS-Q questionnaire (2022 version) will be used to assess physical activity and sedentary behaviour and will be given to the child/adolescent by the investigator to complete. Help will be provided to younger children and children with reading difficulties. The questionnaire will be collected at the end of the visit after it has been completed by the patient.
- Data collection and analysis Imaging data will be pseudonymised, collected and analysed with Olea medical Software( olea-medical.com).
Three regions will be defined:
- Region 1 corresponding to the proximal transitional vertebra
- Region 2 corresponding to the apical vertebra (or disc)
- Region 3 corresponding to the distal transitional vertebra These will then be divided into two zones according to the convexity and concavity of the curvature.
- Region 1 convex / Region 1 concave
- Region 2 convex / Region 2 concave
- Region 3 convex / Region 3 concave
Thus, six regions will be defined and seven parameters per region established, i.e. 42 measurements per MRI:
- Cross-sectional area
- Pennation angle
- Number of muscle fibres
- T1 value
- T2 value
- Anisotropy fraction value
- Diffusivity value (average, radial, axial)
Statistical analysis will be descriptive (prospective descriptive study). Quantitative variables will be described by the mean, standard deviation, median and interquartile range.
Qualitative variables will be described by the number of cases and frequency.
Comparisons will be made between the two groups of children with scoliosis according to the aetiology of the scoliosis.
For each of these parameters, non-parametric tests (Wilcoxon, Mann-Whitney) will be performed.
A p-value < 0.05 will be considered significant. No significant difference will be sought between the two groups of children with scoliosis for each parameter, in order to verify the matching of the groups.
- Age
- Gender
- BMI
- CAPAS-Q score (activity and sedentary lifestyle)
- Cobb angle value;
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Additional 5 minutes of lying down position during MRIDuring 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). | Procedure or surgery | idiopathic scoliosis (IS), neuromuscular scoliosis (NMS) |
Primary outcome
Muscular parameters defined in areas of specific interest and studied in the concavity and convexity of the main curvature: Cross-sectional area
Time frame: 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: Pennation angle
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Muscular parameters defined in areas of specific interest and studied in the concavity and convexity of the main curvature: T2 value
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hélène Gouz, MD principal investigator
CHU Raymond Poincaré - APHP
Robert Carlier, MD, PhD study director
CHU Raymond Poincaré - APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Additional 5 minutes of lying down position during MRI in people with Scoliosis and Scoliosis Idiopathic, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hélène Gouz, MD (+33149094674, helene.gouze@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscular parameters defined in areas of specific interest and studied in the concavity and convexity of the main curvature: Cross-sectional area (time frame: at baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.