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

Cervical Spinal Cord Injury Clinical Trial

Official title:

Diffusion Tensor MRI to Assess Subacute Functional Outcomes in Patients With Acute Cervical Spinal Cord Injuries

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01712698
• Other study ID #: DTI
• Secondary ID: Washington Unive
• Status: Withdrawn
• Start date: January 2014
• Est. completion date: January 2016

Study information

• Verified date: April 2018
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Spinal Cord Injury
• Spinal Cord Injuries
• Wounds and Injuries

Locations

Country	Name	City	State
United States	Washington University, School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in AISA score	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).	24 months