Dynamic MRI and Quantitative MR CSF Flow Studies in Craniovertebral Junction Anomalies (NCT00795080) | Clinical Trial Compass
By InvitationNot Applicable
Dynamic MRI and Quantitative MR CSF Flow Studies in Craniovertebral Junction Anomalies
50 participantsStarted 2012-07-15
Plain-language 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.
This study will be done with patients who have abnormalities of the neck, including Chiari 1 malformations.
Who can participate
Age range
12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.