Trial record 3 of 7 for:    Tethered Spinal Cord Syndrome

Magnetic Resonance Imaging of the Spine (MRIS)

This study has been terminated.
(No patients were enrolled, due to logistic difficulties, no funding was acquired.)
Sponsor:
Information provided by:
Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier:
NCT01382290
First received: September 13, 2005
Last updated: June 24, 2011
Last verified: May 2011
  Purpose

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 Intervention
Tethered Cord
Chiari I Malformation
Procedure: MRI

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Magnetic Resonance Imaging of the Spine

Resource links provided by NLM:


Further study details as provided by Children's Healthcare of Atlanta:

Enrollment: 0
Study Start Date: March 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01382290

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

No publications provided

Responsible Party: Richard Jones, PhD, Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier: NCT01382290     History of Changes
Other Study ID Numbers: MRI DIffusion Spine
Study First Received: September 13, 2005
Last Updated: June 24, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Healthcare of Atlanta:
MRI
Spine
Diffusion

Additional relevant MeSH terms:
Congenital Abnormalities

ClinicalTrials.gov processed this record on August 01, 2014