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

NCT ID: NCT00795080

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-07-15

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chiari Malformations

Keywords

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CVJ malformations

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Normal volunteers who do not have malformations in their cerebral spinal fluid (CSF)

Dynamic cervical MRI scans

Intervention Type PROCEDURE

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)

Dynamic cervical MRI scans

Intervention Type PROCEDURE

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.

Dynamic cervical MRI scans

Intervention Type PROCEDURE

Serial MRI examination with the neck in flexion and extension to document changes in the cord compression and cerebral spinal fluid (CSF)

Interventions

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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)

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Jayapalli Rajiv Bapuraj, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rajiv Bapuraj, M.D., MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Other Identifiers

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HUM 18481

Identifier Type: -

Identifier Source: org_study_id