Chiari MalformationsNCT00795080
Dynamic MRI and Quantitative MR CSF Flow Studies in Craniovertebral Junction Anomalies
An observational study of Chiari Malformations, run by University of Michigan.
Trial summary
The purpose of this study is to decide which position of the neck affects cerebral spinal fluid (CSF) flow between the spinal cord and the brain. CSF is a fluid that flows up and down your spinal cord, around the brain and into the ventricles of the brain. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chiari Malformations
- What is being tested?
- Dynamic cervical MRI scans
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2012to Dec 2026
- Phase
- Observational
- 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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Pilot group consisting of 10 healthy volunteers. Patients recruited w/incidental findings of Chiari 1 malformations and Patients recruited with known Chiari and other CVJ malformations (prior to surgery)
Who may be able to join
- Healthy volunteers must be 18 yrs of age or older.
- Patients w/Chiari 1 or CVJ malformations aged 12 yrs or older,
- Able to cooperate in flexing and extending their neck within the cervical spine coil used for MR Imaging.
- Pediatric patients will be included only if they can cooperate for additional sequences done for the study who don't require sedation or any form of anesthesia.
Who cannot join
- Patients who are medically unstable or cannot voluntarily flex or extend their necks.
- Patients who have hardware in the head or necks which are incompatible with MR imaging.
- Patient requiring any form of sedation which can lead to compromise of the airway with maneuvers described above.
- History of prior head trauma or history of neurological conditions which can result in altered CSF dynamics.
About this study
Official title: Dynamic Magnetic Resonance Imaging (MRI) and Quantitative MR Cerebral Spinal Fluid (CSF) Flow Studies in Craniovertebral Junction Anomalies
The purpose of this study is to decide which position of the neck affects cerebral spinal fluid (CSF) flow between the spinal cord and the brain. CSF is a fluid that flows up and down your spinal cord, around the brain and into the ventricles of the brain.
This study will be done with patients who have abnormalities of the neck, including Chiari 1 malformations.
Read the detailed description
In this study, subjects will have a dynamic cervical magnetic resonance imaging (MRI) of the craniovertebral junction (CVJ) coupled with CSF flow studies. The studies will assess changes in CSF flow velocities that are associated with with changing position of the neck at the CVJ and aqueduct of Sylvius.
Eligible patients include those with Chiari 1 malformations and similar malformations to the CVJ. This malformation lead to inherent instability in this region and symptoms such as headaches, dizziness, neck pain and other neurological problems. This study will determine if there is any correlation of these MRI findings to clinical outcome.
- Conditions
- Chiari Malformations
- Being tested
- Dynamic cervical MRI scans
- Keywords
- CVJ malformations
- 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 cervical MRI scansProcedure or surgery
Serial MRI examination with the neck in flexion and extension to document changes in the cord compression and cerebral spinal fluid (CSF)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Normal volunteers who do not have malformations in their cerebral spinal fluid (CSF) Receives: Procedure: Dynamic cervical MRI scans | |
| 2 | Patients with incidentally discovered Chiari 1 DVS malformation of the cerebral spinal fluid (CSF) Receives: Procedure: Dynamic cervical MRI scans | |
| 3 | Patients with known Chiari or any other CVJ malformations undergoing a workup prior to surgery. Research images will be added to the clinically ordered exams ordered at 3 months and 1 year after surgery. Receives: Procedure: Dynamic cervical MRI scans |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare changes in flow velocities at the CVJ (cranial vertebral junction) and aqueduct of Sylvius w/dynamic imaging in normal controls and in patients with symptomatic and asymptomatic Chiari 1 malformations and similar anomalies.
Measured: 1 year
Secondary outcomes (1)
Results from the primary outcome will be correlated with post operative changes in a subset of patients as a predictor for surgical outcomes.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2008 (estimated)
- Study start15 Jul 2012
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chiari MalformationsStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jayapalli Rajiv Bapuraj, MD, University of Michigan
- Investigators
- Rajiv Bapuraj, M.D., MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00795080
- Sponsor's protocol ID
- HUM 18481
- Status last verified
- Dec 2025
- First submitted
- 20 Nov 2008
- Last updated
- 29 Dec 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 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Magnetic Resonance Imaging (MRI) and Quantitative MR Cerebral Spinal Fluid (CSF) Flow Studies in Craniovertebral Junction Anomalies
- ClinicalTrials.gov ID
- NCT00795080
- Acronym / sponsor ID
- HUM 18481
- Conditions
- Chiari Malformations
- Keywords
- CVJ malformations
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 15 Jul 2012 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Nov 2008 (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.
The purpose of this study is to decide which position of the neck affects cerebral spinal fluid (CSF) flow between the spinal cord and the brain. CSF is a fluid that flows up and down your spinal cord, around the brain and into the ventricles of the brain.
This study will be done with patients who have abnormalities of the neck, including Chiari 1 malformations.
Detailed description
In this study, subjects will have a dynamic cervical magnetic resonance imaging (MRI) of the craniovertebral junction (CVJ) coupled with CSF flow studies. The studies will assess changes in CSF flow velocities that are associated with with changing position of the neck at the CVJ and aqueduct of Sylvius.
Eligible patients include those with Chiari 1 malformations and similar malformations to the CVJ. This malformation lead to inherent instability in this region and symptoms such as headaches, dizziness, neck pain and other neurological problems. This study will determine if there is any correlation of these MRI findings to clinical outcome.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: Dynamic cervical MRI scansNormal volunteers who do not have malformations in their cerebral spinal fluid (CSF) |
| 2 | – | Procedure: Dynamic cervical MRI scansPatients with incidentally discovered Chiari 1 DVS malformation of the cerebral spinal fluid (CSF) |
| 3 | – | Procedure: Dynamic cervical MRI scansPatients with known Chiari or any other CVJ malformations undergoing a workup prior to surgery. Research images will be added to the clinically ordered exams ordered at 3 months and 1 year after surgery. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pilot group consisting of 10 healthy volunteers. Patients recruited w/incidental findings of Chiari 1 malformations and Patients recruited with known Chiari and other CVJ malformations (prior to surgery)
Key inclusion criteria (4 listed)
- Healthy volunteers must be 18 yrs of age or older.
- Patients w/Chiari 1 or CVJ malformations aged 12 yrs or older,
- Able to cooperate in flexing and extending their neck within the cervical spine coil used for MR Imaging.
- Pediatric patients will be included only if they can cooperate for additional sequences done for the study who don't require sedation or any form of anesthesia.
Key exclusion criteria (4 listed)
- Patients who are medically unstable or cannot voluntarily flex or extend their necks.
- Patients who have hardware in the head or necks which are incompatible with MR imaging.
- Patient requiring any form of sedation which can lead to compromise of the airway with maneuvers described above.
- History of prior head trauma or history of neurological conditions which can result in altered CSF dynamics.
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 cervical MRI scansSerial MRI examination with the neck in flexion and extension to document changes in the cord compression and cerebral spinal fluid (CSF) | Procedure or surgery | 1, 2, 3 |
Primary outcome
To compare changes in flow velocities at the CVJ (cranial vertebral junction) and aqueduct of Sylvius w/dynamic imaging in normal controls and in patients with symptomatic and asymptomatic Chiari 1 malformations and similar anomalies.
Time frame: 1 year
1 secondary outcome
Results from the primary outcome will be correlated with post operative changes in a subset of patients as a predictor for surgical outcomes.
Time frame: 1 year
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 29 Dec 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.
Rajiv Bapuraj, M.D., MD principal investigator
University of Michigan
Questions about this trial
What is this clinical trial studying?
An observational study of Chiari Malformations, run by University of Michigan.
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 4 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: enrolling by invitation, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
To compare changes in flow velocities at the CVJ (cranial vertebral junction) and aqueduct of Sylvius w/dynamic imaging in normal controls and in patients with symptomatic and asymptomatic Chiari 1 malformations and similar anomalies. (time frame: 1 year). 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 29 Dec 2025.