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Diffusion Tensor Imaging to Assess the Functional Outcomes of Adults With Cervical Spinal Cord Injuries

This study is not yet open for participant recruitment.
Verified October 2012 by Washington University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Wilson Z. Ray, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01712698
First received: October 17, 2012
Last updated: October 19, 2012
Last verified: October 2012
History of Changes
  Purpose

Acute changes in axial diffusivity will correlate with the severity of injury in patients that suffer an acute spinal cord injury.


Condition
Cervical Spinal Cord Injury

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diffusion Tensor MRI to Assess Subacute Functional Outcomes in Patients With Acute Cervical Spinal Cord Injuries

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Change in AISA score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Patients will be followed for the duration of their hospital stay with clinical follow-up out to 2 years. ASIA scores will be correlated with admission DTI findings(Axial Diffusivity).


Estimated Enrollment: 20
Study Start Date: January 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cervical spinal cord injury
Those patients with an acute cervical spinal cord injury evaluated with DTI MRI

Detailed Description:

Diffusion tensor imaging (DTI) parameters will correlate with severity of spinal cord injury in SCI patients as seen in rodent models. We will test whether the quantitative decrease in axial (λ║) diffusivity (a biomarker of axonal injury), will predict long-term functional outcomes for patients with a SCI.

Specific Aim: To examine patients after an acute SCI using DTI and to correlate the extent of acute decrease in λ║ with the presenting ASIA motor score and long-term functional outcome of the patient.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with a traumatic cervical spinal cord injury

Criteria

Inclusion Criteria:

  • 18-65 years of age
  • Cervical spinal cord injury
  • physically and mentally willing to comply with imaging
  • lives in immediate area with no plans to relocate

Exclusion Criteria:

  • Associated moderate to severe head injury
  • Active malignancy
  • Previous spinal cord injury
  • pregnancy
  • inability to tolerate MRI scanning
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01712698

Contacts
Contact: Jeanine Wade, RT 314-362-2940 wadej@mir.wustl.edu
Contact: Rory Murphy, MD 314-294-1654 murphyr@wudosis.wustl.edu

Locations
United States, Missouri
Washington University, School of Medicine Active, not recruiting
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Wilson Z. Ray, Assistant Professor, Neurosurgery, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01712698     History of Changes
Other Study ID Numbers: DTI, Washington University
Study First Received: October 17, 2012
Last Updated: October 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
trauma
spinal cord injury
cervical spine

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
 Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on May 21, 2013