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

November 2, 2023 updated by: Jayapalli Rajiv Bapuraj, MD, University of Michigan

Dynamic Magnetic Resonance Imaging (MRI) and Quantitative MR Cerebral Spinal Fluid (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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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

Enrollment (Estimated)

50

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

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)

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Investigators

  • Principal Investigator: Rajiv Bapuraj, M.D., MD, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2012

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

November 20, 2008

First Submitted That Met QC Criteria

November 20, 2008

First Posted (Estimated)

November 21, 2008

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 2, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM 18481

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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