Overview

This trial is active, not recruiting.

Condition chiari malformations
Treatment dynamic cervical mri scans
Sponsor University of Michigan
Start date July 2012
End date December 2016
Trial size 40 participants
Trial identifier NCT00795080, HUM 18481

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
Normal volunteers who do not have malformations in their cerebral spinal fluid (CSF)
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)
Patients with incidentally discovered Chiari 1 DVS malformation of the cerebral spinal fluid (CSF)
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)
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.
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 Outcomes

Measure
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 Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 12 years old.

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.

Additional Information

Official title Dynamic Magnetic Resonance Imaging (MRI) and Quantitative MR Cerebral Spinal Fluid (CSF) Flow Studies in Craniovertebral Junction Anomalies
Principal investigator Rajiv Bapuraj, M.D., MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by University of Michigan.