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Trial record 3 of 10 for:    Tethered Spinal Cord Syndrome

Magnetic Resonance Imaging of the Spine (MRIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01382290
Recruitment Status : Withdrawn (No patients were enrolled, due to logistic difficulties, no funding was acquired.)
First Posted : June 27, 2011
Last Update Posted : August 9, 2016
Information provided by:
Children's Healthcare of Atlanta

Brief Summary:

Diffusion-weighted (DW) magnetic resonance imaging (MRI) imaging is a well established method for detecting acute injury to the brain and is used on all children undergoing an MRI brain scan at Children's Healthcare of Atlanta. The possibility of using DW MRI to study other areas of the body, such as the spinal cord, has been recognised as having great clinical potential. However, two main problems have hindered the clinical application of the technique; firstly, the extreme motion sensitivity of the technique meant that respiratory motion have hampered clinical studies. Secondly, the close proximity of the spinal cord to the bones in the spinal column complicates the application of the techniques developed for the brain to the spine. Recently, several techniques have been developed which address these problems and these are now available on the MRI scanners used at Children's Healthcare of Atlanta.

We now wish to evaluate how well these techniques work on children in a routine clinical setting. For this reason we wish to add a single scan of the spine to the imaging protocol of children receiving a routine scan of the brain or spine. This will permit us to evaluate the image quality in both normal and abnormal spines. We plan on enrolling 60 patients with normal spines and 30 patients with abnormal spines. No additional sedation and/or contrast will be required and the additional imaging time for the diffusion studies will be less than 10 minutes. Parental consent will be a pre-requisite for any patient to be enrolled into the study.

Condition or disease Intervention/treatment Phase
Tethered Cord Chiari I Malformation Procedure: MRI Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Magnetic Resonance Imaging of the Spine
Study Start Date : March 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with tethered cords.
  • Patients with Chiari I malformations.
  • Normal children undergoing a MRI of the spine.

Exclusion Criteria:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01382290

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United States, Georgia
Childrens Healthcare at Scottish Rite
Atlanta, Georgia, United States, 30342
Sponsors and Collaborators
Children's Healthcare of Atlanta
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Principal Investigator: Richard Jones, PhD Emory University/Children's Healthcare of Atlanta

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Responsible Party: Richard Jones, PhD, Children's Healthcare of Atlanta Identifier: NCT01382290     History of Changes
Other Study ID Numbers: MRI DIffusion Spine
First Posted: June 27, 2011    Key Record Dates
Last Update Posted: August 9, 2016
Last Verified: August 2016

Keywords provided by Children's Healthcare of Atlanta:

Additional relevant MeSH terms:
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Congenital Abnormalities