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

Chiari Malformations Clinical Trial

Official title:

Dynamic Magnetic Resonance Imaging (MRI) and Quantitative MR Cerebral Spinal Fluid (CSF) Flow Studies in Craniovertebral Junction Anomalies

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00795080
• Other study ID #: HUM 18481
• Status: Enrolling by invitation
• Start date: July 15, 2012
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arnold-Chiari Malformation
• Chiari Malformations
• Congenital Abnormalities

Intervention

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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		1 year
Secondary	Results from the primary outcome will be correlated with post operative changes in a subset of patients as a predictor for surgical outcomes.		1 year