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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 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: February 3, 2014
Last verified: February 2014
  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:


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 2014
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: January 2016 (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
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: 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

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: February 3, 2014
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
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System

ClinicalTrials.gov processed this record on July 10, 2014