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Recruiting NCT07135765

NCT07135765 Paravertebral Muscles Assessment Using High-resolution MRI in Idiopathic or Neuromuscular Scoliosis Children

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Clinical Trial Summary
NCT ID NCT07135765
Status Recruiting
Phase
Sponsor Assistance Publique - Hôpitaux de Paris
Condition Scoliosis
Study Type INTERVENTIONAL
Enrollment 10 participants
Start Date 2025-07-17
Primary Completion 2027-08

Eligibility & Interventions

Sex All sexes
Min Age 10 Years
Max Age 17 Years
Study Type INTERVENTIONAL
Interventions
Additional 5 minutes of lying down position during MRI

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 10 participants in total. It began in 2025-07-17 with a primary completion date of 2027-08.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

Eligibility Criteria

Inclusion Criteria: * 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). Exclusion Criteria: * 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)

Contact & Investigator

Central Contact

Hélène Gouz, MD

✉ helene.gouze@aphp.fr

📞 +33149094674

Principal Investigator

Hélène Gouz, MD

PRINCIPAL INVESTIGATOR

CHU Raymond Poincaré - APHP

Frequently Asked Questions

Who can join the NCT07135765 clinical trial?

This trial is open to participants of all sexes, aged 10 Years or older, up to 17 Years, studying Scoliosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07135765 currently recruiting?

Yes, NCT07135765 is actively recruiting participants. Contact the research team at helene.gouze@aphp.fr for enrollment information.

Where is the NCT07135765 trial being conducted?

This trial is being conducted at Garches, France.

Who is sponsoring the NCT07135765 clinical trial?

NCT07135765 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Hélène Gouz, MD at CHU Raymond Poincaré - APHP. The trial plans to enroll 10 participants.

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