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

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ClinicalTrials.gov Identifier: NCT01712698
Recruitment Status : Unknown
Verified February 2014 by Wilson Z. Ray, Washington University School of Medicine.
Recruitment status was:  Recruiting
First Posted : October 23, 2012
Last Update Posted : February 5, 2014
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease
Cervical Spinal Cord Injury

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.


Study Design

Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diffusion Tensor MRI to Assess Subacute Functional Outcomes in Patients With Acute Cervical Spinal Cord Injuries
Study Start Date : January 2014
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Cervical spinal cord injury
Those patients with an acute cervical spinal cord injury evaluated with DTI MRI


Outcome Measures

Primary Outcome Measures :
  1. Change in AISA score [ Time Frame: 24 months ]
    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).


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Recruiting
St. Louis, Missouri, United States, 63110
Contact: Jeanine Wade, RT    314-362-2940    wadej@mir.wustl.edu   
Contact: Rory Murphy, MD    314-294-1654    murphyr@wudosis.wustl.edu   
Principal Investigator: Wilson Ray, MD         
Sub-Investigator: Sheng-Kwei Song, PhD         
Sub-Investigator: Rory Murphy, MD         
Sponsors and Collaborators
Washington University School of Medicine
More Information

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 ( Other Identifier: Washington University, St. Louis )
First Posted: October 23, 2012    Key Record Dates
Last Update Posted: February 5, 2014
Last Verified: February 2014

Keywords provided by Wilson Z. Ray, Washington University School of Medicine:
trauma
spinal cord injury
cervical spine

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