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Trial record 5 of 15 for:    Arnold-Chiari Malformation

Dynamic MRI and Quantitative MR CSF Flow Studies in Craniovertebral Junction Anomalies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00795080
Recruitment Status : Active, not recruiting
First Posted : November 21, 2008
Last Update Posted : February 13, 2018
Sponsor:
Information provided by (Responsible Party):
Jayapalli Rajiv Bapuraj, MD, University of Michigan

Brief 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.


Condition or disease Intervention/treatment
Chiari Malformations Procedure: Dynamic cervical MRI scans

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 Type : Observational
Actual Enrollment : 43 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Dynamic Magnetic Resonance Imaging (MRI) and Quantitative MR Cerebral Spinal Fluid (CSF) Flow Studies in Craniovertebral Junction Anomalies
Actual Study Start Date : July 15, 2012
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans
U.S. FDA Resources

Group/Cohort Intervention/treatment
1
Normal volunteers who do not have malformations in their cerebral spinal fluid (CSF)
Procedure: Dynamic cervical MRI scans
Serial MRI examination with the neck in flexion and extension to document changes in the cord compression and cerebral spinal fluid (CSF)
2
Patients with incidentally discovered Chiari 1 DVS malformation of the cerebral spinal fluid (CSF)
Procedure: Dynamic cervical MRI scans
Serial MRI examination with the neck in flexion and extension to document changes in the cord compression and cerebral spinal fluid (CSF)
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.
Procedure: Dynamic cervical MRI scans
Serial MRI examination with the neck in flexion and extension to document changes in the cord compression and cerebral spinal fluid (CSF)



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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)
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00795080


Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Rajiv Bapuraj, M.D., MD University of Michigan

Responsible Party: Jayapalli Rajiv Bapuraj, MD, Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT00795080     History of Changes
Other Study ID Numbers: HUM 18481
First Posted: November 21, 2008    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jayapalli Rajiv Bapuraj, MD, University of Michigan:
CVJ malformations

Additional relevant MeSH terms:
Congenital Abnormalities
Arnold-Chiari Malformation
Neural Tube Defects
Nervous System Malformations
Nervous System Diseases