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Enrolling by Invitation

NCT Number: NCT00795080

Dynamic MRI and Quantitative MR 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dynamic cervical MRI scans

Procedure

Serial MRI examination with the neck in flexion and extension to document changes in the cord compression and cerebral spinal fluid (CSF)

Primary outcomes

  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.

    Time frame: 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.

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

Dynamic Magnetic Resonance Imaging (MRI) and Quantitative MR Cerebral Spinal Fluid (CSF) Flow Studies in Craniovertebral Junction Anomalies

Important dates

Study start
2012
Primary completion
2026
Study completion
2026
First posted
Nov 21, 2008
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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