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

NCT01868958 | Completed

• 1 other identifier: IRB00058267
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cervical Spondylosis With Myelopathy

Keywords

Magnetic resonance imaging (MRI); Diffusion tensor imaging; Spine

Outcome Measures

Primary Outcomes (1)

• Diffusion properties of the spinal cord

  Two parameters characterizing 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 quantity has no units. 2. The trace of the diffusion tensor. This measures the mean diffusivity of the water in the spinal cord and is measured in m\^2/sec.

  The diffusion properties are measured in a single imaging session lasting approximately 50 minutes.

Study Arms (2)

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

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• controls : Aged matched to the patient group. No history of CSM.

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• Siemens Medical Solutions: collaborator

Study Sites (1)

Center for Systems Imaging (CSI), Emory University

Atlanta, Georgia, 30329, United States

Location

Related Publications (1)

• Hayes LL, Jones RA, Palasis S, Aguilera D, Porter DA. Drop metastases to the pediatric spine revealed with diffusion-weighted MR imaging. Pediatr Radiol. 2012 Aug;42(8):1009-13. doi: 10.1007/s00247-011-2295-9. Epub 2011 Nov 4.

  PMID: 22052343 BACKGROUND

Study Officials

• Richard A Jones, PhD

  Department of Radiology, Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of Radiology

Study Record Dates

• First Submitted: May 13, 2013
• First Posted: June 5, 2013
• Study Start: January 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: July 15, 2015

Record last verified: 2015-07

Locations

US (1)