Chiari I MalformationNCT04679792
Postual Control in Pediatric Chiari I Malformation
An observational study of Chiari I Malformation and Pediatric, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
BACKGROUND: Chiari I malformation is a rare disease characterized by cerebellar amygdalae descent under the level of the foramen magnum. It causes troubles in cerebrospinal fluid circulation and direct compression on brainstem, producing characteristic headaches, neurological impairment and syringomyelia. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Chiari I Malformation, Pediatric
- What is being tested?
- Dynamic posturography
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2019to Sep 2022
- How long will I take part?
- 10 Years
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric patients aged from 6 to 18 years, received for neurosurgical counseling at our institution with a radiologically confirmed Chiari I malformation and presenting ENT symptomes like dizziness, nystagmus, gait imbalance, motion sickness and Chiari not-related migraines. Patients will be selected for surgery in habitual fashion, indipendently on the study. The patients will be divided into 2 groups: patients who will be operated on and patients who won't be operated on.
Who may be able to join
- Radiologically confirmed diagnosis of Chiari I malformation (first MRI realized up to 1/01/2018)
- ENT symptomes (dizziness, nystagmus, gait imbalance, migraines not due to the presence of Chiari Malformation)
Who cannot join
- Lack of cooperation (cerebral palsy, severe behavioral troubles, orthopedic illness, severe visual impairment)
- Patient's consent for study non obtained.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Stella Irene
Vandœuvre-lès-Nancy, Lorraine, 54500
Stella Irene, MD, 0383155207, i.stella@chru-nancy.fr
KLEIN Olivier, 0383155211, o.klein@chru-nancy.fr
About this study
Official title: Postural Control Quality in Chiari I Malformation: Evaluation in a Pediatric Population
BACKGROUND: Chiari I malformation is a rare disease characterized by cerebellar amygdalae descent under the level of the foramen magnum. It causes troubles in cerebrospinal fluid circulation and direct compression on brainstem, producing characteristic headaches, neurological impairment and syringomyelia. Surgery is the only treatment, indicated when symptomatology exists. However, sometimes patients complaint about atypical symptoms that are difficult to interpret.
We would like to study one of these atypical symptoms, gait imbalance, in a pediatric population thanks to a computerized dynamic posturography (Equitest®).
Read more
METHOD: infants from 6 to 18 years of age presenting a radiologically confirmed Chiari I malformation will be included in the study. We will compare posturographic results of patients which will be operated on with the results of the patients which will not; furthermore, we will compare preoperative and postoperative results in operated patients.
RESULTS: 19 patients have been enrolled in the study, and data have been collected for 12 of them. Seven patients belong to operated population.
CONCLUSIONS: even if enrolment of the patients is satisfactory, disposable data are not enough to perform statistical analysis and to put forward any conclusion.
Read the detailed description
Chiari malformation is characterized by at least 5 mm descent of cerebellar tonsils below the foramen magnum, into the vertebral canal. Historical classification of this malformation consists in four different types, but it is the first one, due to a congenital small posterior fossa, which represent our focus of interest. Chiari malformation may leads to direct brainstem compression and to cerebrospinal fluid circulation trouble at this level, being cause of classical associated phenomena such as syringomyelia formation.
The clinical manifestation may be resumed as follow:
- Exertional headaches or neck pain.
- Brainstem compression signs and symptoms (central apneas syndrome, tetraparesis, paresthesia, cranial nerves disfunction...).
- Syringomyelia signes and symptoms (neuropathic pain, suspended hypo-anesthesia).
The only treatment for Chiari I malformation is the surgical one. It consists in an osteo-dural decompression of the posterior fossa. Surgical decision is formal when at least one of the following criteria is satisfied:
- presence of syringomyelia;
- coexistence of central apneas syndrome;
- presence of the classical symptomatology. Nevertheless, the spectrum of symptoms which might be reported by the patient, and which has even been described in the non neurosurgical literature, is largely wider than the previously thought and assumed by the neurosurgeons. There are so several "atypical symptoms" in which neurosurgeons doesn't believed, and that don't constitute an indicator for surgical intervention. Among these "atypical symptoms" one cas find those ones who bring back to ear, nose and throat domain, such as nystagmus, dizziness, tinnitus, hear loss, and gait instability.
We decided to focalise about one of these symptoms, the gait instability, trying to find the link between Chiari malformation and postural control. In the literature, there are only one study concerning this aspect, conducted on an adult population with the help of a static posturography.
Our study will focus on pediatric patients, who will be evaluated by a dynamic posturography, the Equitest platform (NeuroCom, Clackamas, OR). This platform is able to quantify the contribution of each of the three sensory informations (visual, vestibular and somatosensory) necessary to maintain equilibrium, realising a specific test (Sensory Organisation Test).
The Equitest can elaborate a Composite Equilibrium Score (CES), that will be our PRIMARY JUDGMENT CRITERIA.
Only patients for which ENT evaluation is indicated for medical reasons (for example, children presented frequent falls, dizziness, nystagmus, motion sickness...) will be evaluated.
This evaluation won't change habitual neurosurgical care for the patients presenting Chiari I malformation, so two groups of patients will be identified: children who will be operated on and children who won't. CES of the two groups will be calculated and compared.
Furthermore, we will compared CES results of the operated patients group before and after surgery, to evaluate the impact of surgery on postural control.
In parallel, we will evaluate others SECONDARY CRITERIA in operated patient, before and after surgery, such as :
- signe and symptomss modification;
- decompression result on MRI images;
- syringomyelia modification, if present before;
- central apnea syndrome modification, if present before;
- scoliosis modification, if present before;
- behavioral modification. Anamnestic and clinical data will be part of the habitual computerized medical folder, as well as polysomnographic, posturographic and imaging ones.
Clinical elements of recruited patients will be collected by principal investigator in an anonymous database, secured by a password.
Concerning primary criteria, collected qualitative data will be analysed by Chi-2 or Fischer test, while quantitative ones will be analysed by Student's test or Mann-Whitney one.
Concerning secondary criteria, collected qualitative data will be analysed by Mc Nemar test or symmetry test, while quantitative ones will be analysed by Student's test Wilcoxon one.
- Conditions
- Chiari I Malformation, Pediatric
- Being tested
- Dynamic posturography
- Medical subject headings
- Arnold-Chiari Malformation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic posturographyDiagnostic test
Balance evaluation
| Study group | Role | What they receive |
|---|---|---|
| operated | Patients Under 18 years of age who are operated for Chiari Malformation on the basis of routine neurosurgical assessment. Receives: Diagnostic Test: Dynamic posturography | |
| non operated | Patients Under 18 years of age who are not operated for Chiari Malformation on the basis of routine neurosurgical assessment. Receives: Diagnostic Test: Dynamic posturography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Equilibrium Score
Score elaborated by the Equitest posturography
Measured: Operated patients: from first neurosurgical evaluation to 6 months after surgery (totally: 8-12 months). Non operated patients: about 4 months for complete evaluation.
Secondary outcomes (6)
Cranio cervical MRI
Posterior fossa decompression
Measured: Operated patients: from first neurosurgical evaluation to 6 months after surgery (totally: 8-12 months).
Medullary MRI
Eventual modification in syringomyelia size
Measured: Operated patients: from first neurosurgical evaluation to 6 months after surgery (totally: 8-12 months).
Apnea syndrome
Eventual modification in polysomnographic results (50% reduction of apnea-hypopnea index)
Measured: Operated patients: from first evaluation to 6 months after surgery (totally: 8-12 months).
Clinic
Eventual modification of patient's signes and symptoms
Measured: Operated patients: from first neurosurgical evaluation to 6 months after surgery (totally: 8-12 months).
Scoliosis
Eventual modification of vertebral balance (favorable outcome if Cobb's angle stable)
Measured: Operated patients: from first neurosurgical evaluation to 6 months after surgery (totally: 8-12 months).
Behavior
Parent's description of behavioral trouble
Measured: Operated patients: from first neurosurgical evaluation to 6 months after surgery (totally: 8-12 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start1 Sep 2019
- Primary completionMar 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chiari I MalformationStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lorraine
- Responsible party
- Principal investigator, Philippe PERRIN, Central Hospital, Nancy, France
- Investigators
- Perrin Philippe, PhD, Study director, Nancy Regional University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04679792
- Sponsor's protocol ID
- EquiChiari
- Status last verified
- Dec 2020
- First submitted
- 17 Dec 2020
- Last updated
- 22 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stella I, Remen T, Petel A, Joud A, Klein O, Perrin P. Postural control in Chiari I malformation: protocol for a paediatric prospective, observational cohort - potential role of posturography for surgical indication. BMJ Open. 2022 May 12;12(5):e056647. doi: 10.1136/bmjopen-2021-056647.
PubMed 35551083
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postural Control Quality in Chiari I Malformation: Evaluation in a Pediatric Population
- ClinicalTrials.gov ID
- NCT04679792
- Acronym / sponsor ID
- EquiChiari
- Conditions
- Chiari I Malformation, Pediatric
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- University of Lorraine
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 22 Dec 2020 (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.
BACKGROUND: Chiari I malformation is a rare disease characterized by cerebellar amygdalae descent under the level of the foramen magnum. It causes troubles in cerebrospinal fluid circulation and direct compression on brainstem, producing characteristic headaches, neurological impairment and syringomyelia. Surgery is the only treatment, indicated when symptomatology exists. However, sometimes patients complaint about atypical symptoms that are difficult to interpret.
We would like to study one of these atypical symptoms, gait imbalance, in a pediatric population thanks to a computerized dynamic posturography (Equitest®).
METHOD: infants from 6 to 18 years of age presenting a radiologically confirmed Chiari I malformation will be included in the study. We will compare posturographic results of patients which will be operated on with the results of the patients which will not; furthermore, we will compare preoperative and postoperative results in operated patients.
RESULTS: 19 patients have been enrolled in the study, and data have been collected for 12 of them. Seven patients belong to operated population.
CONCLUSIONS: even if enrolment of the patients is satisfactory, disposable data are not enough to perform statistical analysis and to put forward any conclusion.
Detailed description
Chiari malformation is characterized by at least 5 mm descent of cerebellar tonsils below the foramen magnum, into the vertebral canal. Historical classification of this malformation consists in four different types, but it is the first one, due to a congenital small posterior fossa, which represent our focus of interest. Chiari malformation may leads to direct brainstem compression and to cerebrospinal fluid circulation trouble at this level, being cause of classical associated phenomena such as syringomyelia formation.
The clinical manifestation may be resumed as follow:
- Exertional headaches or neck pain.
- Brainstem compression signs and symptoms (central apneas syndrome, tetraparesis, paresthesia, cranial nerves disfunction...).
- Syringomyelia signes and symptoms (neuropathic pain, suspended hypo-anesthesia).
The only treatment for Chiari I malformation is the surgical one. It consists in an osteo-dural decompression of the posterior fossa. Surgical decision is formal when at least one of the following criteria is satisfied:
- presence of syringomyelia;
- coexistence of central apneas syndrome;
- presence of the classical symptomatology. Nevertheless, the spectrum of symptoms which might be reported by the patient, and which has even been described in the non neurosurgical literature, is largely wider than the previously thought and assumed by the neurosurgeons. There are so several "atypical symptoms" in which neurosurgeons doesn't believed, and that don't constitute an indicator for surgical intervention. Among these "atypical symptoms" one cas find those ones who bring back to ear, nose and throat domain, such as nystagmus, dizziness, tinnitus, hear loss, and gait instability.
We decided to focalise about one of these symptoms, the gait instability, trying to find the link between Chiari malformation and postural control. In the literature, there are only one study concerning this aspect, conducted on an adult population with the help of a static posturography.
Our study will focus on pediatric patients, who will be evaluated by a dynamic posturography, the Equitest platform (NeuroCom, Clackamas, OR). This platform is able to quantify the contribution of each of the three sensory informations (visual, vestibular and somatosensory) necessary to maintain equilibrium, realising a specific test (Sensory Organisation Test).
The Equitest can elaborate a Composite Equilibrium Score (CES), that will be our PRIMARY JUDGMENT CRITERIA.
Only patients for which ENT evaluation is indicated for medical reasons (for example, children presented frequent falls, dizziness, nystagmus, motion sickness...) will be evaluated.
This evaluation won't change habitual neurosurgical care for the patients presenting Chiari I malformation, so two groups of patients will be identified: children who will be operated on and children who won't. CES of the two groups will be calculated and compared.
Furthermore, we will compared CES results of the operated patients group before and after surgery, to evaluate the impact of surgery on postural control.
In parallel, we will evaluate others SECONDARY CRITERIA in operated patient, before and after surgery, such as :
- signe and symptomss modification;
- decompression result on MRI images;
- syringomyelia modification, if present before;
- central apnea syndrome modification, if present before;
- scoliosis modification, if present before;
- behavioral modification. Anamnestic and clinical data will be part of the habitual computerized medical folder, as well as polysomnographic, posturographic and imaging ones.
Clinical elements of recruited patients will be collected by principal investigator in an anonymous database, secured by a password.
Concerning primary criteria, collected qualitative data will be analysed by Chi-2 or Fischer test, while quantitative ones will be analysed by Student's test or Mann-Whitney one.
Concerning secondary criteria, collected qualitative data will be analysed by Mc Nemar test or symmetry test, while quantitative ones will be analysed by Student's test Wilcoxon one.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| operated | – | Diagnostic Test: Dynamic posturographyPatients Under 18 years of age who are operated for Chiari Malformation on the basis of routine neurosurgical assessment. |
| non operated | – | Diagnostic Test: Dynamic posturographyPatients Under 18 years of age who are not operated for Chiari Malformation on the basis of routine neurosurgical assessment. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients aged from 6 to 18 years, received for neurosurgical counseling at our institution with a radiologically confirmed Chiari I malformation and presenting ENT symptomes like dizziness, nystagmus, gait imbalance, motion sickness and Chiari not-related migraines. Patients will be selected for surgery in habitual fashion, indipendently on the study. The patients will be divided into 2 groups: patients who will be operated on and patients who won't be operated on.
Key inclusion criteria (2 listed)
- Radiologically confirmed diagnosis of Chiari I malformation (first MRI realized up to 1/01/2018)
- ENT symptomes (dizziness, nystagmus, gait imbalance, migraines not due to the presence of Chiari Malformation)
Key exclusion criteria (2 listed)
- Lack of cooperation (cerebral palsy, severe behavioral troubles, orthopedic illness, severe visual impairment)
- Patient's consent for study non obtained.
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 |
|---|---|---|
| Dynamic posturographyBalance evaluation | Diagnostic test | non operated, operated |
Primary outcome
Composite Equilibrium Score
Time frame: Operated patients: from first neurosurgical evaluation to 6 months after surgery (totally: 8-12 months). Non operated patients: about 4 months for complete evaluation.
Score elaborated by the Equitest posturography
6 secondary outcomes
Cranio cervical MRI
Time frame: Operated patients: from first neurosurgical evaluation to 6 months after surgery (totally: 8-12 months).
Medullary MRI
Time frame: Operated patients: from first neurosurgical evaluation to 6 months after surgery (totally: 8-12 months).
Apnea syndrome
Time frame: Operated patients: from first evaluation to 6 months after surgery (totally: 8-12 months).
Clinic
Time frame: Operated patients: from first neurosurgical evaluation to 6 months after surgery (totally: 8-12 months).
Scoliosis
Time frame: Operated patients: from first neurosurgical evaluation to 6 months after surgery (totally: 8-12 months).
Behavior
Time frame: Operated patients: from first neurosurgical evaluation to 6 months after surgery (totally: 8-12 months).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2020.
- Derived from this study: PubMed 35551083Stella I, Remen T, Petel A, Joud A, Klein O, Perrin P. Postural control in Chiari I malformation: protocol for a paediatric prospective, observational cohort - potential role of posturography for surgical indication. BMJ Open. 2022 May 12;12(5):e056647. doi: 10.1136/bmjopen-2021-056647.
- 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.
Perrin Philippe, PhD study director
Nancy Regional University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chiari I Malformation and Pediatric, run by Central Hospital, Nancy, France 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 22 Dec 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stella Irene, MD (+33383155207, i.stella@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Equilibrium Score (time frame: Operated patients: from first neurosurgical evaluation to 6 months after surgery (totally: 8-12 months). Non operated patients: about 4 months for complete evaluation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04679792, which also lists 1 linked publication.
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 Dec 2020.