Type I Chiari MalformationNEUROFLUX-CNCT06502431
Analysis of Disturbances in Neurofluid Dynamics in Type I Chiari Malformations
A study testing phase contrast sequences in people with Type I Chiari Malformation and Cerebral Hemodynamic, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
A global analysis of craniospinal hemodynamics and hydrodynamics is necessary to better understand the pathophysiology of Chiari malformations. This includes an analysis of intraventricular CSF flow, intracranial subarachnoid spaces, foramen magnum, cervical subarachnoid spaces and within the syringomyelia cavity when… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Type I Chiari Malformation, Cerebral Hemodynamic, Craniospinal Hydrodynamic
- What is being tested?
- phase contrast sequences
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 24 Jun 2024to Jul 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All patients with major symptomatic or nonsymptomatic CMI
- aged 18 to 50 years
- no previous neurosurgical, neurological, or cardiological history.
- Controls should be age-matched to symptomatic CMI group. They should not have a history of neurosurgery, neurology, or cardiology.
Who cannot join
- Patients who are minors or over 50 years of age
- CMI invalidated by our radiological review
- Neurosurgical, neurological or cardiological history
- MRI contraindication
- pregnant, breast-feeding and parturient women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Amiens Picardie
Amiens, Picardie, 80054
Cyrillle CAPEL, MD, 0322088947, capel.cyrille@chu-amiens.fr
About this study
A global analysis of craniospinal hemodynamics and hydrodynamics is necessary to better understand the pathophysiology of Chiari malformations. This includes an analysis of intraventricular CSF flow, intracranial subarachnoid spaces, foramen magnum, cervical subarachnoid spaces and within the syringomyelia cavity when present. The investigators will also analyze the pulsatility of the cerebellar tonsils in the foramen magnum. Hemodynamic analysis will be performed at the high cervical level (internal carotid and vertebral arteries, jugular veins) and intracranially (carotid and basilar arteries, right sinus and superior longitudinal sinus). This analysis will be made possible by PCMRI acquisitions with slice planes allowing the analysis of the dynamics of the CSF (mesencephalic aqueduct, prepontic cisterns, foramen magnum, at the level of the C2C3 disc, syringomyelia if present), cerebellar tonsils (foramen magnum). The cross-sectional planes for hemodynamic analysis will be at the level of the C2C3 disc (cervical vascular analysis) and upstream of the polygon of Willis (intracranial vascular analysis).
The goal is to complement the clinical and morphological investigations with quantitative imaging of cerebrospinal fluid (CSF) and blood flow in the craniospinal system. These flows are potentially altered or causes of this Chiari anomaly.
The investigators propose a translational research project of clinical research allowing the analysis of a diagnostic technique by a diagnostic, monocentric, prospective study. After neurosurgical consultation, patients with Chiari malformation will be assigned to a symptomatic Chiari malformation or a non-symptomatic Chiari malformation group. They will be offered to participate in this study after information and informed consent. The allocation between the two groups will be made according to the symptomatic or non-symptomatic nature of the Chiari malformation. After inclusion, the patients will have a morphological MRI and a PCMRI according to the determined slice plans and allowing a global analysis of the craniospinal hemohydrodynamics. Craniospinal hemohydrodynamics in a control population will also be analyzed using the same methodology by PCMRI.
- Conditions
- Type I Chiari Malformation, Cerebral Hemodynamic, Craniospinal Hydrodynamic, Phase Contrast MRI, Cerebrospinal Fluid
- Being tested
- phase contrast sequences
- Keywords
- Type I Chiari Malformation, Cerebral hemodynamic, Craniospinal hydrodynamic, Phase contrast MRI, Cerebrospinal fluid
- 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.
phase contrast sequencesOther
patients will benefit from phase contrast sequences complementary to the morphological MRI performed as part of the patient management.
| Study group | Role | What they receive |
|---|---|---|
| Symptomatic CMI group | Experimental | Not described Receives: Other: phase contrast sequences |
| Non-Symptomatic CMI group | Experimental | Not described Receives: Other: phase contrast sequences |
| Control group | Active comparator | Not described Receives: Other: phase contrast sequences |
What is being measured
The primary outcome is the main question the study is designed to answer.
CSF Flow
Flow will be measured by the oscillatory volume expressed in mL/cardiac cycle.
Measured: day 1
Blood Flow
Flow will be measured by the oscillatory volume expressed in mL/cardiac cycle.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start24 Jun 2024
- Primary completion1 Apr 2025
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type I Chiari 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06502431
- Sponsor's protocol ID
- PI2023_843_0033
- Acronym
- NEUROFLUX-C
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2024
- Last updated
- 8 Sep 2026
- 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 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Disturbances in Neurofluid Dynamics in Type I Chiari Malformations
- ClinicalTrials.gov ID
- NCT06502431
- Acronym / sponsor ID
- NEUROFLUX-C / PI2023_843_0033
- Conditions
- Type I Chiari Malformation, Cerebral Hemodynamic, Craniospinal Hydrodynamic, Phase Contrast MRI, Cerebrospinal Fluid
- Keywords
- Type I Chiari Malformation, Cerebral hemodynamic, Craniospinal hydrodynamic, Phase contrast MRI, Cerebrospinal fluid
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- Jul 2027 (estimated)
- First posted
- 16 Jul 2024 (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.
A global analysis of craniospinal hemodynamics and hydrodynamics is necessary to better understand the pathophysiology of Chiari malformations. This includes an analysis of intraventricular CSF flow, intracranial subarachnoid spaces, foramen magnum, cervical subarachnoid spaces and within the syringomyelia cavity when present. The investigators will also analyze the pulsatility of the cerebellar tonsils in the foramen magnum. Hemodynamic analysis will be performed at the high cervical level (internal carotid and vertebral arteries, jugular veins) and intracranially (carotid and basilar arteries, right sinus and superior longitudinal sinus). This analysis will be made possible by PCMRI acquisitions with slice planes allowing the analysis of the dynamics of the CSF (mesencephalic aqueduct, prepontic cisterns, foramen magnum, at the level of the C2C3 disc, syringomyelia if present), cerebellar tonsils (foramen magnum). The cross-sectional planes for hemodynamic analysis will be at the level of the C2C3 disc (cervical vascular analysis) and upstream of the polygon of Willis (intracranial vascular analysis).
The goal is to complement the clinical and morphological investigations with quantitative imaging of cerebrospinal fluid (CSF) and blood flow in the craniospinal system. These flows are potentially altered or causes of this Chiari anomaly.
The investigators propose a translational research project of clinical research allowing the analysis of a diagnostic technique by a diagnostic, monocentric, prospective study. After neurosurgical consultation, patients with Chiari malformation will be assigned to a symptomatic Chiari malformation or a non-symptomatic Chiari malformation group. They will be offered to participate in this study after information and informed consent. The allocation between the two groups will be made according to the symptomatic or non-symptomatic nature of the Chiari malformation. After inclusion, the patients will have a morphological MRI and a PCMRI according to the determined slice plans and allowing a global analysis of the craniospinal hemohydrodynamics. Craniospinal hemohydrodynamics in a control population will also be analyzed using the same methodology by PCMRI.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Symptomatic CMI group | Experimental | Other: phase contrast sequences |
| Non-Symptomatic CMI group | Experimental | Other: phase contrast sequences |
| Control group | Active comparator | Other: phase contrast sequences |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- All patients with major symptomatic or nonsymptomatic CMI
- aged 18 to 50 years
- no previous neurosurgical, neurological, or cardiological history.
- Controls should be age-matched to symptomatic CMI group. They should not have a history of neurosurgery, neurology, or cardiology.
Key exclusion criteria (5 listed)
- Patients who are minors or over 50 years of age
- CMI invalidated by our radiological review
- Neurosurgical, neurological or cardiological history
- MRI contraindication
- pregnant, breast-feeding and parturient women
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 |
|---|---|---|
| phase contrast sequencespatients will benefit from phase contrast sequences complementary to the morphological MRI performed as part of the patient management. | Other | Control group, Non-Symptomatic CMI group, Symptomatic CMI group |
Primary outcome
CSF Flow
Time frame: day 1
Flow will be measured by the oscillatory volume expressed in mL/cardiac cycle.
Blood Flow
Time frame: day 1
Flow will be measured by the oscillatory volume expressed in mL/cardiac cycle.
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 8 Sep 2026.
- 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 phase contrast sequences in people with Type I Chiari Malformation and Cerebral Hemodynamic, run by Centre Hospitalier Universitaire, Amiens 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 4 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: looking for participants now, as of the sponsor's last update on 8 Sep 2026. 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 Cyrille Capel, MD (0322088947, capel.cyrille@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CSF Flow (time frame: day 1). The study lists 2 primary outcomes in all. 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 8 Sep 2026.