Scoliosis Idiopathic AdolescentSCOLIO-PROPRIONCT07208929
Investigating Proprioceptive Impairment in Adolescents With Idiopathic Scoliosis (AIS) (SCOLIO-PROPRIO)
A study testing MRI in people with Scoliosis Idiopathic Adolescent, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
The goal of this interventionnal study is to learn if teenagers who have severe scoliosis (a curvature of the spine) have trouble sensing their body's position in space (this sense is called proprioception), which are directly linked to abnormalities in the part of the brain that controls movement and/or caused by the… Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Scoliosis Idiopathic Adolescent
- What is being tested?
- MRI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2025to Dec 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adolescents diagnosed with Adolescent Idiopathic Scoliosis (AIS) and followed in the pediatric orthopedic surgery department, scheduled to undergo spinal fusion surgery (arthrodesis)
- No history or clinical signs of neurological disorders
- Aged between 10 and 18 years
- Written informed consent obtained from both the adolescent and their legal guardians (parents)
- Control Group only: Participants will be selected from open-access neuroimaging databases, matched to the patient group by age and sex.
Who cannot join
- Presence of any other clinically significant condition that could be associated with spinal deformity
- Insufficient proficiency in French to understand the informed consent form
- Current treatment with psychotropic medication
- Ongoing pregnancy or breastfeeding
- Subject under legal or judicial supervision
- Contraindications to brain MRI (including: pacemaker; electrically, magnetically, or mechanically activated implants; surgical clips; metallic sutures; staples; etc. - see MRI safety questionnaire annex)
- Subject or their parent(s)/legal guardian(s) refuse to be informed of incidental findings detected during MRI
- Claustrophobia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Investigating Proprioceptive Impairment in Adolescents With Idiopathic Scoliosis (AIS)
The goal of this interventionnal study is to learn if teenagers who have severe scoliosis (a curvature of the spine) have trouble sensing their body's position in space (this sense is called proprioception), which are directly linked to abnormalities in the part of the brain that controls movement and/or caused by the muscles on each side of the spine not being the same size or not developing in the same way.
The main question the investigators aim to answer are :
Read more
- Do adolescents with severe scoliosis have problems with their sense of body position (proprioception)?
- If so, are these proprioceptive issues linked to specific problems in the part of the brain that controls movement?
- Are these proprioceptive issues also possibly linked to an uneven muscle structure on either side of the spinal curve?
Researchers will compare the part of the brain that controls movement (ensorimotor brain network) of healthy subjects to that of the participants that will enroll in this study.
Participants will only have to do one more MRI that is not included in the routine of clinical management of scoliosis before surgery.
Data will also be retrieved from clinical practice Participants will answer questionnaires after the day of the surgery
Read the detailed description
Adolescent Idiopathic Scoliosis (AIS) affects 2 to 4% of the pediatric population. While its exact etiology remains unclear, one leading hypothesis implicates deficits in muscle proprioception, though this remains poorly understood. In addition, structural and functional alterations in brain connectivity have been reported in AIS patients, raising the possibility of a neurobiological underpinning linked to proprioceptive dysfunction.
The primary objective of this study is to determine whether adolescents with severe AIS requiring surgical treatment exhibit structural alterations in the brain's sensorimotor network compared to age-matched control subjects, and whether these alterations are associated with their level of proprioceptive sensitivity. A secondary objective is to assess whether resting-state functional connectivity within the sensorimotor network is also disrupted in AIS patients and whether these functional changes correlate with proprioceptive performance.
The investigators will combine behavioral assessments of static and dynamic proprioception with structural (diffusion MRI) and functional (resting-state fMRI) neuroimaging (using MR scanner at 3T). Static proprioception will be assessed using a joint repositioning test, while dynamic proprioception will be evaluated through vibration-induced movement illusions. This is a prospective, single-center study involving 30 AIS patients and 30 age- and gender-matched healthy controls drawn from open-access neuroimaging databases.
Demonstrating a correlation between brain network alterations and proprioceptive deficits in AIS would provide new evidence in favor of a neuroproprioceptive origin of scoliosis. Such findings could pave the way for the development of targeted proprioceptive rehabilitation strategies in affected adolescents.
- Conditions
- Scoliosis Idiopathic Adolescent
- Being tested
- MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIRadiation
Brain and Spinal Cord MRI
| Study group | Role | What they receive |
|---|---|---|
| Patients with Adolescent Idiopathic Scoliosis | Experimental | Not described Receives: Radiation: MRI |
| Healthy subjects | No intervention | External control arm of 30 healthy volounteers from the Human Connectome project from where MRI images will be retrieved. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between scoliosis and structural brain alteration as assed by dynamic proprioception test and MRI
Values of fractional anisotropy (FA) in the corpus callosum and interhemispheric tracts connecting the somatosensory and motor cortices will be compared between the 2 groups of participants
- The differences found between the two groups (patients versus control) will be correlated to the proprioceptive performances in the patient group as assed by motion illusion amplitude index
Measured: One day before surgery
Secondary outcomes (5)
Resting state functional connectivity (rs-FC) alteration in AIS assed by MRI
We are expecting lower resting-state functional connectivity in patients' sensorimotor network compared to control subjects. We will estimate significant differences in functional connectivity between the 2 groups by comparing connectivity maps
Measured: One day before surgery
Correlation between Resting-State Functional Connectivity (z-score) as assessed from brain MRI's and Proprioceptive Performance as assessed by measuring the Reproduced Leg Extension Amplitude in degres (°)
Identification of the sensorimotor network regions that are most strongly connected in relation to proprioceptive performance by including the illusory range-of-motion index as a co-variate
Measured: Day before surgery
Correlation between scoliosis gravity as assessed by the cobb angle (°) with previous MRI's and propriovceptive performance as assessed by measuring the Reproduced Leg Extension Amplitude in degres (°) and the quantified gait analysis (°)
Dynamic proprioceptive sensitivity - reflected by range-of-motion index - and proprioceptive static sensitivity - reflected by repositioning error - in relation to scoliosis severity estimated on the basis of patients' Cobb angle.
Measured: One day before surgery
Analysis of scores on body perception as assed by the BESAA
Assessment of body perception by the Body-Esteem Scale for Adolescents and Adults, zero is equivalent to low body perception and 4 is good body perception for each item.
Measured: From day one after surgery to 14 day after surgery
Physical activity as assessed by the Physical Effort Scale (PES) correlated with cobb angle
Physical activity will be assessed by the Physical effort scale will be correlated with the patient's cobb angle retrieved from clinical routine of scoliosis management
Measured: From day one after surgery to 14 day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study startOct 2025 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis Idiopathic AdolescentStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Model description
- Propsective, monocentric, comparative study
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07208929
- Sponsor's protocol ID
- 2025-A00864-45
- Acronym
- SCOLIO-PROPRIO
- Status last verified
- Sep 2025
- First submitted
- 17 Sep 2025
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Proprioceptive Impairment in Adolescents With Idiopathic Scoliosis (AIS)
- ClinicalTrials.gov ID
- NCT07208929
- Acronym / sponsor ID
- SCOLIO-PROPRIO / 2025-A00864-45
- Conditions
- Scoliosis Idiopathic Adolescent
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 6 Oct 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.
The goal of this interventionnal study is to learn if teenagers who have severe scoliosis (a curvature of the spine) have trouble sensing their body's position in space (this sense is called proprioception), which are directly linked to abnormalities in the part of the brain that controls movement and/or caused by the muscles on each side of the spine not being the same size or not developing in the same way.
The main question the investigators aim to answer are :
- Do adolescents with severe scoliosis have problems with their sense of body position (proprioception)?
- If so, are these proprioceptive issues linked to specific problems in the part of the brain that controls movement?
- Are these proprioceptive issues also possibly linked to an uneven muscle structure on either side of the spinal curve?
Researchers will compare the part of the brain that controls movement (ensorimotor brain network) of healthy subjects to that of the participants that will enroll in this study.
Participants will only have to do one more MRI that is not included in the routine of clinical management of scoliosis before surgery.
Data will also be retrieved from clinical practice Participants will answer questionnaires after the day of the surgery
Detailed description
Adolescent Idiopathic Scoliosis (AIS) affects 2 to 4% of the pediatric population. While its exact etiology remains unclear, one leading hypothesis implicates deficits in muscle proprioception, though this remains poorly understood. In addition, structural and functional alterations in brain connectivity have been reported in AIS patients, raising the possibility of a neurobiological underpinning linked to proprioceptive dysfunction.
The primary objective of this study is to determine whether adolescents with severe AIS requiring surgical treatment exhibit structural alterations in the brain's sensorimotor network compared to age-matched control subjects, and whether these alterations are associated with their level of proprioceptive sensitivity. A secondary objective is to assess whether resting-state functional connectivity within the sensorimotor network is also disrupted in AIS patients and whether these functional changes correlate with proprioceptive performance.
The investigators will combine behavioral assessments of static and dynamic proprioception with structural (diffusion MRI) and functional (resting-state fMRI) neuroimaging (using MR scanner at 3T). Static proprioception will be assessed using a joint repositioning test, while dynamic proprioception will be evaluated through vibration-induced movement illusions. This is a prospective, single-center study involving 30 AIS patients and 30 age- and gender-matched healthy controls drawn from open-access neuroimaging databases.
Demonstrating a correlation between brain network alterations and proprioceptive deficits in AIS would provide new evidence in favor of a neuroproprioceptive origin of scoliosis. Such findings could pave the way for the development of targeted proprioceptive rehabilitation strategies in affected adolescents.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Propsective, monocentric, comparative study
| Arm | Type | Receives |
|---|---|---|
| Patients with Adolescent Idiopathic Scoliosis | Experimental | Radiation: MRI |
| Healthy subjects | No intervention | –External control arm of 30 healthy volounteers from the Human Connectome project from where MRI images will be retrieved. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Adolescents diagnosed with Adolescent Idiopathic Scoliosis (AIS) and followed in the pediatric orthopedic surgery department, scheduled to undergo spinal fusion surgery (arthrodesis)
- No history or clinical signs of neurological disorders
- Aged between 10 and 18 years
- Written informed consent obtained from both the adolescent and their legal guardians (parents)
- Control Group only: Participants will be selected from open-access neuroimaging databases, matched to the patient group by age and sex.
Key exclusion criteria (8 listed)
- Presence of any other clinically significant condition that could be associated with spinal deformity
- Insufficient proficiency in French to understand the informed consent form
- Current treatment with psychotropic medication
- Ongoing pregnancy or breastfeeding
- Subject under legal or judicial supervision
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 |
|---|---|---|
| MRIBrain and Spinal Cord MRI | Radiation | Patients with Adolescent Idiopathic Scoliosis |
Primary outcome
Correlation between scoliosis and structural brain alteration as assed by dynamic proprioception test and MRI
Time frame: One day before surgery
Values of fractional anisotropy (FA) in the corpus callosum and interhemispheric tracts connecting the somatosensory and motor cortices will be compared between the 2 groups of participants - The differences found between the two groups (patients versus control) will be correlated to the proprioceptive performances in the patient group as assed by motion illusion amplitude index
5 secondary outcomes
Resting state functional connectivity (rs-FC) alteration in AIS assed by MRI
Time frame: One day before surgery
Correlation between Resting-State Functional Connectivity (z-score) as assessed from brain MRI's and Proprioceptive Performance as assessed by measuring the Reproduced Leg Extension Amplitude in degres (°)
Time frame: Day before surgery
Correlation between scoliosis gravity as assessed by the cobb angle (°) with previous MRI's and propriovceptive performance as assessed by measuring the Reproduced Leg Extension Amplitude in degres (°) and the quantified gait analysis (°)
Time frame: One day before surgery
Analysis of scores on body perception as assed by the BESAA
Time frame: From day one after surgery to 14 day after surgery
Physical activity as assessed by the Physical Effort Scale (PES) correlated with cobb angle
Time frame: From day one after surgery to 14 day after surgery
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 6 Oct 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with Scoliosis Idiopathic Adolescent, run by Assistance Publique Hopitaux De Marseille 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 5 inclusion and 8 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: opening soon, as of the sponsor's last update on 6 Oct 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 KAVOUNOUDIAS (+33(0)4 13 55 08 42, anne.kavounoudias@univ-amu.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between scoliosis and structural brain alteration as assed by dynamic proprioception test and MRI (time frame: One day before surgery). 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 6 Oct 2025.