Trial record 18 of 27 for:
Open Studies | "Cervical Vertebrae"
DTI of the Brain and Cervical Spine: Evaluation in Normal Subjects and Patients With Cervical Spondylotic Myelopathy
This study is currently recruiting participants.
Verified November 2013 by Emory University
Siemens Medical Solutions
Information provided by (Responsible Party):
Richard Jones, Emory University
First received: May 13, 2013
Last updated: November 20, 2013
Last verified: November 2013
More than half of the middle-aged population has radiologic evidence of cervical spondylosis (Irvine 1965) and a subset of this population develops cervical spondylotic myelopathy (CSM), a condition in which the spinal cord is impaired, either by direct mechanical compression or indirectly by arterial deprivation and/or venous stasis. In this study we aim to test the hypothesis that diffusion tensor imaging can provide prognostic information on the integrity of the spine in these patients which is unavailable from conventional MRI images
Cervical Spondylosis With Myelopathy
||Observational Model: Case Control
Time Perspective: Prospective
||Diffusion Tensor Imaging of the Brain and Cervical Spine: Evaluation of Reproducibility in Normal Subjects and Diagnostic Utility in Patients With Cervical Spondylotic Myelopathy
Primary Outcome Measures:
- Diffusion properties of the spinal cord [ Time Frame: The diffsuion properties are measured in a single imaging session lasting approximately 50 minutes. ] [ Designated as safety issue: No ]
Two parameters charachterising the diffusion of water in the spinal cord will be studied.
- The fractional anisotropy reflects the orientational motion of water and the average value will be assessed over the length of the cervical spine for both the control and patient groups. This quantitiy has no units.
- The trace of the diffusion tensor. This measures the mean diffsuivity of the water in the spinal cord and is measured in m^2/sec.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||April 2014 (Final data collection date for primary outcome measure)
Subjects with clinical indications of cervical spondylotic myelopathy (CSM).
Aged matched to the CSM group but with no signs of CSM
|Ages Eligible for Study:
||30 Years to 70 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients at the Emory Orthopaedics & Spine Center suffering signs and symptoms of cervical myelopathy and with evidence of radiographic cervical cord compression with or without abnormal spinal cord signal intensity secondary to spondylosis.
- 20 patients will be selected by an experienced team of orthopedic specialist from the Emory Orthopaedics & Spine Center and will include patients suffering signs and symptoms of cervical myelopathy and with evidence of radiographic cervical cord compression with or without abnormal spinal cord signal intensity secondary to spondylosis.
- 20 controls : Aged matched to the patient group. No history of CSM.
- Any history of significant trauma implicating the brain or cervical spine, including prior motor vehicle collision and history of prior brain, neck or cervical spine surgery.
- Any history of neurological disease
- Dental braces or similar orthodontic devices.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01868958
|Center for Systems Imaging (CSI), Emory University
|Atlanta, Georgia, United States, 30329 |
Siemens Medical Solutions
||Richard A Jones, PhD
||Department of Radiology, Emory University
||Richard Jones, Assistant professor of Radiology, Emory University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 13, 2013
||November 20, 2013
||United States: Institutional Review Board
Keywords provided by Emory University:
Magnetic resonance imaging (MRI)
Diffusion tensor imaging
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 15, 2014
Bone Marrow Diseases
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases