Adolescent Idiopathic ScoliosisMEDULLOSCOLNCT04760808
Evaluation of Cerebrospinal Fluid Flow in Adolescent Idiopathic Scoliosis
An observational study of Adolescent Idiopathic Scoliosis, run by Lille Catholic University at 2 sites in France.
Trial summary
Adolescent Idiopathic Scoliosis (AIS) is the most frequent spinal deformity in adolescence, but its etiology remains unknown. Recent publications suggest a link between ciliopathy and AIS. Read more about this study
- Who is it for?
- Ages 12 to 17 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- Baseline Clinical Examination, Initial 3T MRI of the Brain and Spine and 6-month Follow-up Clinical Examination
- Type of treatment
- Surgery or procedure
- How many people
- 72 participants
- Where
- 2 sitesFrance
- Study dates
- 10 Feb 2021to 4 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 12 to 17 years
- Women only
- Healthy volunteers accepted
- Child
Study population: 2 Groups: * 35 cases: Female Adolescents with AIS * 35 controls: Female subjects without scoliosis
Common Inclusion Criteria for the 2 groups :
- Female subject aged 12 to < 18 years old
- Affiliated to the French social security system
- Having signed the inform consent form
- Whose parents have given their consent
Additional Inclusion Criteria for the AIS group:
- Subject with right thoracic AIS defined by the existence of a 3D spine deformation with a frontal deviation to right dorsal convexity with a Cobb angle of at least 20°, and a rotation of at least 20°, as evidenced by the presence of a vertebral gibbosity ≥ 5° at the Bunnel scoliometer.
If the scoliosis has more than one curvature, the right chest curvature should be the greatest high (highest frontal Cobb angle)
- Subject with x-rays of total spine, face and profile under load, according to the EOS technique, dating from less than 3 months.
Common Exclusion Criteria for the 2 groups:
- Instability to submit to the medical follow-up of the study for psychic, social or geographical reasons
- At least 6 "cafe au lait" spots with a size ≥ 1.5 cm (may be suggestive of neurofibromatosis)
- Ligament hyperlaxity confirmed by a Beighton score >4/9 (which may be suggestive of scoliosis secondary)
- Contraindications of a cerebro-medullary MRI: claustrophobia, foreign bodies, and ferrometallic clips of the trunk or cephalic segment, cochlear implants, stimulators and implantable cardiac defibrillators, insulin pump
- Inequality in length of the lower limbs ≥ 20 mm on clinical examination
- Subject presenting neurological signs (signs of pyramidal irritation, sensory-motor deficit, clinical signs suggestive of cerebellar pathology ...)
- Known vestibular pathology
- Taking psychotropic drugs
Additional exclusion criterion for the AIS group:
- Subject with secondary scoliosis : neurological, orthopedic, malformative...
Additional criteria for the control group:
- Subject with a scoliosis angle ≥ 10° on a photogrammetric screening assessment (optical process, non-irradiating, which allows an Morphometric evaluation of the trunk in 3D, thanks to the analysis of the trunk reliefs)
- Subject whose clinical examination shows a gibbosity measurable (>5°) with the scoliometer of Bunnel
Trial locations and contacts
2 sites in 1 country.
France2 sites
GHICL Hôpital Saint Philibert, service d'Imagerie Médicale
Lomme, Nord, 59462
SSR Pédiatrique Marc Sautelet
Villeneuve-d'Ascq, Nord (59), 59650
About this study
Official title: Evaluation of Cerebrospinal Fluid Flow by MRI in Adolescent Idiopathic Scoliosis, From Its Signaling Through the Study of Trunk Graviception and Proprioception
Adolescent Idiopathic Scoliosis (AIS) is the most frequent spinal deformity in adolescence, but its etiology remains unknown. Recent publications suggest a link between ciliopathy and AIS. More specifically a modification of the cerebro-spinal fluid (CSF) flow by ciliary dysfunction could be at the origin of a scoliotic deformity.
This study aims to compare the CSF flow measured by magnetic resonance imaging (MRI) in an AIS group and a control group.
- Conditions
- Adolescent Idiopathic Scoliosis
- Being tested
- Baseline Clinical Examination, Initial 3T MRI of the Brain and Spine, 6-month Follow-up Clinical Examination, 6-month Follow-up 3T MRI of the Brain and Spine
- Keywords
- cerebrospinal fluid flow, MRI, Graviception, Postural control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baseline Clinical ExaminationDiagnostic test
Evaluations of Postural control; Subjective postural vertical; Subjective visual vertical; Verticality perception
Initial 3T MRI of the Brain and SpineRadiation
Non-injected CSF flow MRI
6-month Follow-up Clinical ExaminationDiagnostic test
Evaluations of Postural control; Subjective postural vertical; Subjective visual vertical; Verticality perception
6-month Follow-up 3T MRI of the Brain and SpineRadiation
Non-injected CSF flow MRI
| Study group | Role | What they receive |
|---|---|---|
| AIS group | Not described Receives: Diagnostic Test: Baseline Clinical Examination; Radiation: Initial 3T MRI of the Brain and Spine; Diagnostic Test: 6-month Follow-up Clinical Examination; Radiation: 6-month Follow-up 3T MRI of the Brain and Spine | |
| Control Group | Not described Receives: Diagnostic Test: Baseline Clinical Examination; Radiation: Initial 3T MRI of the Brain and Spine |
What is being measured
The primary outcome is the main question the study is designed to answer.
CSF flow (cm/s) at the 7th thoracic vertebra (T7)
The flow will be measured by MRI
Measured: 6 months
Secondary outcomes (13)
CSF flow (cm/s) at the cervico-occipital junction
The flow will be measured by MRI
Measured: 6 months
CSF flow (cm/s) at the cerebral aqueduct
The flow will be measured by MRI
Measured: 6 months
Prevalence of spinal cord abnormalities
Measured by MRI
Measured: 6 months
Correlation between the Body Mass Index and the CSF flow (cm/s) at the 7th thoracic vertebra (T7)
This association will be studied by a linear regression analysis
Measured: 6 months
Cobb frontal angle in degrees
The measurement of radiographic parameters will be done with the EOS system. The EOS system is a new slot-scanning radiological device that allows simultaneous acquisition of frontal and lateral images. It is composed of two X-ray sources, shaped as fan beams through collimation slits.
Measured: 6 month
Distance between the vertical line passing through the middle of the sacrum and the vertical line passing through the spine of the 7th cervical vertebra.
Measured: 6 month
Angle of thoracic kyphosis T4-T12 in degrees
The measurement of radiographic parameters will be done with the EOS system.
Measured: 6 months
Lumbar lordosis angle L1-L5 in degrees
The measurement of radiographic parameters will be done with the EOS system.
Measured: 6 months
Lumbo-sacral angle L5-S1 in degrees
The measurement of radiographic parameters will be done with the EOS system The measurement of radiographic parameters will be done with the EOS system.
Measured: 6 months
Pelvic incidence in degrees
The measurement of radiographic parameters will be done with the EOS system
Measured: 6 months
Subjective Postural Vertical Measurement in degrees
Measured: 6 months
Subjective Visual Vertical Sight Measurement in degrees
Measured: 6 months
Proprioception Measurement in degrees
Proprioception measurement obtained by trunk repositioning error test (Formetric system)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start10 Feb 2021
- Primary completion4 May 2022
- Study completion4 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Idiopathic ScoliosisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Collaborators
- SSR pédiatrique Marc Sautelet
- Responsible party
- Sponsor
- Investigators
- Jean-François CATANZARITI, MD, Principal investigator, SSR Marc Sautelet, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04760808
- Sponsor's protocol ID
- RC-P0093
- Acronym
- MEDULLOSCOL
- Status last verified
- Sep 2024
- First submitted
- 16 Feb 2021
- Last updated
- 19 Sep 2024
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cerebrospinal Fluid Flow by MRI in Adolescent Idiopathic Scoliosis, From Its Signaling Through the Study of Trunk Graviception and Proprioception
- ClinicalTrials.gov ID
- NCT04760808
- Acronym / sponsor ID
- MEDULLOSCOL / RC-P0093
- Conditions
- Adolescent Idiopathic Scoliosis
- Keywords
- cerebrospinal fluid flow, MRI, Graviception, Postural control
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Collaborators
- SSR pédiatrique Marc Sautelet
- Study start
- 10 Feb 2021 (actual)
- Primary completion
- 4 May 2022 (actual)
- Study completion
- 4 May 2022 (actual)
- First posted
- 18 Feb 2021 (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.
Adolescent Idiopathic Scoliosis (AIS) is the most frequent spinal deformity in adolescence, but its etiology remains unknown. Recent publications suggest a link between ciliopathy and AIS. More specifically a modification of the cerebro-spinal fluid (CSF) flow by ciliary dysfunction could be at the origin of a scoliotic deformity.
This study aims to compare the CSF flow measured by magnetic resonance imaging (MRI) in an AIS group and a control group.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AIS group | – | Diagnostic Test: Baseline Clinical Examination, Radiation: Initial 3T MRI of the Brain and Spine, Diagnostic Test: 6-month Follow-up Clinical Examination, Radiation: 6-month Follow-up 3T MRI of the Brain and Spine |
| Control Group | – | Diagnostic Test: Baseline Clinical Examination, Radiation: Initial 3T MRI of the Brain and Spine |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 2 Groups: * 35 cases: Female Adolescents with AIS * 35 controls: Female subjects without scoliosis
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 |
|---|---|---|
| Baseline Clinical ExaminationEvaluations of Postural control; Subjective postural vertical; Subjective visual vertical; Verticality perception | Diagnostic test | AIS group, Control Group |
| Initial 3T MRI of the Brain and SpineNon-injected CSF flow MRI | Radiation | AIS group, Control Group |
| 6-month Follow-up Clinical ExaminationEvaluations of Postural control; Subjective postural vertical; Subjective visual vertical; Verticality perception | Diagnostic test | AIS group |
| 6-month Follow-up 3T MRI of the Brain and SpineNon-injected CSF flow MRI | Radiation | AIS group |
Primary outcome
CSF flow (cm/s) at the 7th thoracic vertebra (T7)
Time frame: 6 months
The flow will be measured by MRI
13 secondary outcomes
CSF flow (cm/s) at the cervico-occipital junction
Time frame: 6 months
CSF flow (cm/s) at the cerebral aqueduct
Time frame: 6 months
Prevalence of spinal cord abnormalities
Time frame: 6 months
Correlation between the Body Mass Index and the CSF flow (cm/s) at the 7th thoracic vertebra (T7)
Time frame: 6 months
Cobb frontal angle in degrees
Time frame: 6 month
Distance between the vertical line passing through the middle of the sacrum and the vertical line passing through the spine of the 7th cervical vertebra.
Time frame: 6 month
Angle of thoracic kyphosis T4-T12 in degrees
Time frame: 6 months
Lumbar lordosis angle L1-L5 in degrees
Time frame: 6 months
Lumbo-sacral angle L5-S1 in degrees
Time frame: 6 months
Pelvic incidence in degrees
Time frame: 6 months
Subjective Postural Vertical Measurement in degrees
Time frame: 6 months
Subjective Visual Vertical Sight Measurement in degrees
Time frame: 6 months
Proprioception Measurement in degrees
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- 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. This study is not recruiting at the moment.
Jean-François CATANZARITI, MD principal investigator
SSR Marc Sautelet, France
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adolescent Idiopathic Scoliosis, run by Lille Catholic University at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CSF flow (cm/s) at the 7th thoracic vertebra (T7) (time frame: 6 months). 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 19 Sep 2024.