Diffusion Tensor Imaging to Assess the Functional Outcome... | NCT01712698

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

NCT01712698

Sponsor

Washington University School of Medicine

Status

Withdrawn

Last Update Posted

May 3, 2018Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Cervical Spinal Cord Injury

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Washington University	Other Identifier	Washington University, St. Louis

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Jan 2016Actual

Completion Date

Jan 2016Actual

First Submitted Date

Oct 17, 2012

First Submission Date that Met QC Criteria

Oct 19, 2012

First Posted Date

Oct 23, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 30, 2018

Last Update Posted Date

May 3, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cervical spinal cord injury		Those patients with an acute cervical spinal cord injury evaluated with DTI MRI

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with a traumatic cervical spinal cord injury

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Washington University, School of Medicine		St Louis	Missouri	63110	United States

Condition Browse Module

MeSH Terms

ID	Term
D014947	Wounds and Injuries
D013119	Spinal Cord Injuries

Ancestor Terms

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D020196	Trauma, Nervous System

Browse Leaves

Not provided

Browse Branches

Not provided