DTI of the Brain and Cervical Spine: Evaluation in Normal Subjects and Patients With Cervical Spondylotic Myelopathy

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Emory University
Sponsor:
Collaborator:
Siemens Medical Solutions
Information provided by (Responsible Party):
Richard Jones, Emory University
ClinicalTrials.gov Identifier:
NCT01868958
First received: May 13, 2013
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

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


Condition
Cervical Spondylosis With Myelopathy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Diffusion Tensor Imaging of the Brain and Cervical Spine: Evaluation of Reproducibility in Normal Subjects and Diagnostic Utility in Patients With Cervical Spondylotic Myelopathy

Resource links provided by NLM:


Further study details as provided by Emory University:

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.

    1. 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.
    2. 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: 40
Study Start Date: January 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
CSM subjects
Subjects with clinical indications of cervical spondylotic myelopathy (CSM).
Control group
Aged matched to the CSM group but with no signs of CSM

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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.

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • Claustrophobia
  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: NCT01868958

Contacts
Contact: Angie Williams, BSc 404-778-5624 angela.williams@emoryhealthcare.org
Contact: Kyle Webb, MSc 404-778-6381 kyle.webb2@emory.edu

Locations
United States, Georgia
Center for Systems Imaging (CSI), Emory University Recruiting
Atlanta, Georgia, United States, 30329
Sponsors and Collaborators
Emory University
Siemens Medical Solutions
Investigators
Principal Investigator: Richard A Jones, PhD Department of Radiology, Emory University
  More Information

Publications:
Responsible Party: Richard Jones, Assistant professor of Radiology, Emory University
ClinicalTrials.gov Identifier: NCT01868958     History of Changes
Other Study ID Numbers: IRB00058267
Study First Received: May 13, 2013
Last Updated: May 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Magnetic resonance imaging (MRI)
Diffusion tensor imaging
Spine

Additional relevant MeSH terms:
Bone Marrow Diseases
Spondylosis
Spinal Osteophytosis
Spinal Cord Diseases
Hematologic Diseases
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 16, 2014