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Trial record 5 of 25 for:    Arnold-Chiari Malformation
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Magnetic Resonance Imaging (MRI) and Quantitative MR Cerebral Spinal Fluid (CSF) Flow Studies in Craniovertebral Junction Anomalies

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Rajiv Bapuraj, M.D., University of Michigan
ClinicalTrials.gov Identifier:
NCT00795080
First received: November 20, 2008
Last updated: January 15, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Chiari Malformations
 Procedure: Dynamic cervical MRI

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Dynamic MRI and Quantitative MR CSF Flow Studies in Craniovertebral Junction Anomalies

Resource links provided by NLM:

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

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • To compare changes in flow velocities at the CVJ 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: July 2008
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Normal volunteers
 Procedure: Dynamic cervical MRI
Serial MRI examination with the neck in flexion and extension to document changes in the cord compression.
2
Patients with incidentally discovered Chiari 1 malformation.
 Procedure: Dynamic cervical MRI
Serial MRI examination with the neck in flexion and extension to document changes in the cord compression.
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 that are ordered at 3 months and 1 year after surgery.
 Procedure: Dynamic cervical MRI
Serial MRI examination with the neck in flexion and extension to document changes in the cord compression.

Detailed Description:

To perform dynamic cervical magnetic resonance imaging (MRI) of the craniovertebral junction (CVJ) coupled with CSF flow studies to assess changes in CSF flow velocities with changing position of the neck at the CVJ and aqueduct of Sylvius in patients with Chiari 1 malformations and similar malformations fo the CVJ leading to inherent instability in this region, and determine if there is any correlation of these findings to clinical outcome.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
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 must be 12 yrs of age or older,
  • Who can 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 the additional sequences for the study and will not require sedation or any form of anesthesia.

Exclusion Criteria:

  • Patients who are medically unstable or cannot voluntarily flex or extend their necks.
  • Patients' hardware placed 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 lead to altered CSF dynamics that can interfere with the outcome of this study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00795080

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

No publications provided

Responsible Party: Rajiv Bapuraj, M.D., Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT00795080     History of Changes
Other Study ID Numbers: HUM 18481
Study First Received: November 20, 2008
Last Updated: January 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
CVJ malformations

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

ClinicalTrials.gov processed this record on May 19, 2013