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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jayapalli Rajiv Bapuraj, MD, University of Michigan
ClinicalTrials.gov Identifier:
NCT00795080
First received: November 20, 2008
Last updated: February 8, 2017
Last verified: February 2017
  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 scans

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


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 ]

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 ]

Enrollment: 43
Study Start Date: July 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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)

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   (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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00795080

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

Responsible Party: Jayapalli Rajiv Bapuraj, MD, 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: February 8, 2017
Individual Participant Data  
Plan to Share IPD: No

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 March 23, 2017