Adolescent Idiopathic ScoliosisMOR-FO-SIANCT02302534
Pilot Study of Functional and Morphometric Brain Abnormalities Related to Adolescent Idiopathic Scoliosis (MOR-FO-SIA)
A study testing MRI in people with Adolescent Idiopathic Scoliosis, run by University Hospital, Tours at 1 site in France.
Trial summary
Adolescent idiopathic scoliosis (AIS) is a complex deformity with different curves. These different curves may be distinguished by different physiopathologic mechanisms. Without fully convincing model of the emergence and development of AIS, their multifactorial nature seems evident. Read more about this study
- Who is it for?
- Ages 14 to 16 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2014to Jun 2015
- Phase
- Interventional
- 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 14 to 16 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- female
- between 14 and 16 years old
- normal neurological examination
- right handed
- informed consent
- informed consent form signed by a parent or a holder of parental authority
- affiliated to medical insurance
- negative urine pregnancy test For patients (A-STD) : right thoracic scoliosis with a Cobb angle between 20 and 40° For healthy volunteers (A-N) : no clinical scoliosis
Who cannot join
- pregnant or lactating woman
- antecedents of cranial trauma or cranial intervention, of migraine, of spinal trauma, of scoliosis intervention
- no idiopathic scoliosis
- contraindications to MRI
- patient with a legal protection measure
Trial locations and contacts
1 site in 1 country.
About this study
Adolescent idiopathic scoliosis (AIS) is a complex deformity with different curves. These different curves may be distinguished by different physiopathologic mechanisms.
Without fully convincing model of the emergence and development of AIS, their multifactorial nature seems evident. Several pathophysiological theories involving the central nervous system have been proposed: the AIS would be associated with disturbances of proprioceptive or sensory perception, and/or with integration of this information. This would result in an abnormal body image, responsible for sensorimotor asymmetry that may promote or cause the deformation.
Read more
The Main aim of this study is to find cortical and subcortical morphometric differences in the most common population of AIS (right thoracic AIS) compared to healthy adolescent control girls.
Secondary Objectives are to study the cerebral white matter of the same groups (fractional anisotropy in the main white matter tracts), and activation of sensorimotor neural networks (fMRI activation and functional brain connectivity).
Abnormalities of the studied parameters may be used as biomarkers for AIS diagnosis and classification.
- Conditions
- Adolescent Idiopathic Scoliosis
- Being tested
- MRI
- Keywords
- scoliosis, MRI (Magnetic Resonance Imaging)
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
MRI
| Study group | Role | What they receive |
|---|---|---|
| patients | Experimental | 2 groups with MRI :
- 8 right thoracic AIS participants (Cobb angle between 20 and 40°) Receives: Device: MRI |
| controls subjects | Experimental | - 8 healthy controls (no clinical scoliosis) Receives: Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation in regional cortical and subcortical volume, as measured by MRI
Measured: One day
Secondary outcomes (2)
Variation in fractional anisotropy in the main white matter tracts, as measured by MRI
Measured: one day
Variation in activation of sensorimotor neural networks, as measured by MRI
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2014 (estimated)
- Study startSep 2014
- Primary completionJun 2015
- Study completionJun 2015
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Edouard LORET, MD, Principal investigator, University Hospital of Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02302534
- Sponsor's protocol ID
- PHAO 2014 - JEL / MOR-FO-SIA
- Acronym
- MOR-FO-SIA
- Status last verified
- Aug 2015
- First submitted
- 21 Oct 2014
- Last updated
- 1 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Functional and Morphometric Brain Abnormalities Related to Adolescent Idiopathic Scoliosis (MOR-FO-SIA)
- ClinicalTrials.gov ID
- NCT02302534
- Acronym / sponsor ID
- MOR-FO-SIA / PHAO 2014 - JEL / MOR-FO-SIA
- Conditions
- Adolescent Idiopathic Scoliosis
- Keywords
- scoliosis, MRI (Magnetic Resonance Imaging)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 27 Nov 2014 (estimated)
- 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 a complex deformity with different curves. These different curves may be distinguished by different physiopathologic mechanisms.
Without fully convincing model of the emergence and development of AIS, their multifactorial nature seems evident. Several pathophysiological theories involving the central nervous system have been proposed: the AIS would be associated with disturbances of proprioceptive or sensory perception, and/or with integration of this information. This would result in an abnormal body image, responsible for sensorimotor asymmetry that may promote or cause the deformation.
The Main aim of this study is to find cortical and subcortical morphometric differences in the most common population of AIS (right thoracic AIS) compared to healthy adolescent control girls.
Secondary Objectives are to study the cerebral white matter of the same groups (fractional anisotropy in the main white matter tracts), and activation of sensorimotor neural networks (fMRI activation and functional brain connectivity).
Abnormalities of the studied parameters may be used as biomarkers for AIS diagnosis and classification.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients | Experimental | Device: MRI2 groups with MRI : - 8 right thoracic AIS participants (Cobb angle between 20 and 40°) |
| controls subjects | Experimental | Device: MRI- 8 healthy controls (no clinical scoliosis) |
Who may qualify
- Ages
- 14 to 16 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- female
- between 14 and 16 years old
- normal neurological examination
- right handed
- informed consent
Key exclusion criteria (5 listed)
- pregnant or lactating woman
- antecedents of cranial trauma or cranial intervention, of migraine, of spinal trauma, of scoliosis intervention
- no idiopathic scoliosis
- contraindications to MRI
- patient with a legal protection measure
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 |
|---|---|---|
| MRIMRI | Device | controls subjects, patients |
Primary outcome
Variation in regional cortical and subcortical volume, as measured by MRI
Time frame: One day
2 secondary outcomes
Variation in fractional anisotropy in the main white matter tracts, as measured by MRI
Time frame: one day
Variation in activation of sensorimotor neural networks, as measured by MRI
Time frame: one day
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 1 Sep 2015.
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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-Edouard LORET, MD principal investigator
University Hospital of Tours
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 Adolescent Idiopathic Scoliosis, run by University Hospital, Tours 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: finished, as of the sponsor's last update on 1 Sep 2015. 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?
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?
Variation in regional cortical and subcortical volume, as measured by MRI (time frame: One day). 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 1 Sep 2015.