NCT01712698

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 23, 2012

Completed
1.2 years until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

May 3, 2018

Status Verified

April 1, 2018

Enrollment Period

2 years

First QC Date

October 17, 2012

Last Update Submit

April 30, 2018

Conditions

Cervical Spinal Cord Injury

Keywords

traumaspinal cord injurycervical spine

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Cervical spinal cord injury

Those patients with an acute cervical spinal cord injury evaluated with DTI MRI

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with a traumatic cervical spinal cord injury

You may qualify if:

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

You may not qualify if:

  • Associated moderate to severe head injury
  • Active malignancy
  • Previous spinal cord injury
  • pregnancy
  • inability to tolerate MRI scanning

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University, School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Wounds and InjuriesSpinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous System
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2012

First Posted

October 23, 2012

Study Start

January 1, 2014

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

May 3, 2018

Record last verified: 2018-04

Locations

US(1)