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North American Clinical Trials Network (NACTN) for Treatment of Spinal Cord Injury - Registry (NACTN)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2017 by The Methodist Hospital System
Sponsor:
Collaborators:
Christopher Reeve Paralysis Foundation
The Methodist Hospital System
The University of Texas Health Science Center, Houston
University of Virginia
University of Louisville
University of Toronto
University of Maryland
Walter Reed National Military Medical Center
Thomas Jefferson University
University of Miami
Brooke Army Medical Center
Stanford University
Louisiana State University Health Sciences Center in New Orleans
Information provided by (Responsible Party):
Robert G. Grossman, MD, The Methodist Hospital System
ClinicalTrials.gov Identifier:
NCT00178724
First received: September 13, 2005
Last updated: January 24, 2017
Last verified: January 2017

September 13, 2005
January 24, 2017
July 2005
July 2020   (Final data collection date for primary outcome measure)
International Standards For Neurological Classification of Spinal Injury (ISNCSCI) [ Time Frame: Pre-operative, Post-operative, 2 weeks, Discharge, 3 months, 6 months, 12 months, 36 months and 48 months ]
A neurological assessment and classification of a spinal cord injury
Not Provided
Complete list of historical versions of study NCT00178724 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
North American Clinical Trials Network (NACTN) for Treatment of Spinal Cord Injury - Registry
North American Clinical Trials Network (NACTN) for Treatment of Spinal Cord Injury
The NACTN Spinal Cord Injury Registry is a network of clinical centers collecting de-identified data from patients admitted through the Emergency Department of a NACTN center at the time of injury with an initial (first time) spinal cord injury (SCI). Information will be collected on the natural history of SCI and course of treatment through the first 12 months from the date of injury or long as medically indicated. Data collected includes imaging information from CT or MRI scans, neurological and general medical outcome and rehabilitation evaluation. No intervention is given other than standard of care for spinal cord injury.

The participating centers include:

Houston Methodist Hospital, Houston; University of Texas Health Science Center, Houston; University of Toronto, Toronto; University of Virginia, Charlottesville; University of Louisville, Louisville; University of Maryland, Baltimore; Walter Reed National Military Medical Center, Bethesda, MD; Thomas Jefferson University,Philadelphia; University of Miami, Miami; Brooke Army Medical Center, Fort Sam Houston; Stanford University, Palo Alto Louisiana State University, New Orleans

The Center for Biostatistics is located at:

Houston Methodist Hospital, Houston

The Data Management Center is located at:

The University of Louisville, Louisville

Preliminary work has been completed on the selection of data elements, data collection protocols, case record form design, and the design of a computer system for clinical data management and data quality control.

In the first phase of the network, data will be collected on the natural history of SCI. Although there is considerable data in the literature about the natural history of SCI, current changes in treatment appear to be modifying the natural history. In particular very early surgery, including decompression of the spinal cord and vertebral stabilization with instrumentation appears, in some cases of SCI, to be improving outcomes.

No treatment is given other than standard of care for SCI. Data is collected in hopes to help SCI patients in the future.

Observational
Observational Model: Other
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Admitted to a NACTN hospital through the Emergency Department at the time of injury.
Spinal Cord Injury
Other: No treatment
Intervention is not given.
No Treatment
Any male or female 18 years or older admitted to a NACTN hospital, at the time of injury, with an initial (first time) spinal cord injury caused by trauma and has paralysis/motor weakness or loss of sensation. The patient has not received medical care for this injury prior to admission to a NACTN hospital. Patient/family member must give consent to participate.
Intervention: Other: No treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1500
July 2023
July 2020   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Any patient male or female > or equal to 18 years of age with first time spinal cord injury caused by trauma and has neurological deficit (paralysis/weakness or loss of sensation).
  • Must give informed consent

Exclusion Criteria:

  • Any patient/family refusing consent
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Elizabeth G Toups, MS, RN, CCRP 713-441-3897 etoups@houstonmethodist.org
United States,   Canada
 
 
NCT00178724
Pro00002187
W81XH-13-2-0040 ( Other Grant/Funding Number: Department of Defense )
CTN11-2015(RG) ( Other Identifier: NACTN )
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
No
Not Provided
Robert G. Grossman, MD, The Methodist Hospital System
Robert G. Grossman, MD
  • Christopher Reeve Paralysis Foundation
  • The Methodist Hospital System
  • The University of Texas Health Science Center, Houston
  • University of Virginia
  • University of Louisville
  • University of Toronto
  • University of Maryland
  • Walter Reed National Military Medical Center
  • Thomas Jefferson University
  • University of Miami
  • Brooke Army Medical Center
  • Stanford University
  • Louisiana State University Health Sciences Center in New Orleans
Study Chair: Robert G Grossman, MD Houston Methodist Hospital, Houston
Principal Investigator: Karl M Schmitt, MD The University of Texas, Houston
Principal Investigator: Michael G Fehlings, MD, PhD University of Toronto/Toronto Western Hospital, Toronto
Principal Investigator: Maxwell Boakye, MD University of Louisville, Louisville, Kentucky
Principal Investigator: Bizhan Aarabi, MD University of Maryland Medical Center, Baltimore
Principal Investigator: Christopher I Shaffrey, MD University of Virginia Health System, Charlottesville
Principal Investigator: Christopher J Neal, MD Walter Reed National Military Medical Cener
Principal Investigator: James S Harrop, MD Thomas Jefferson University
Principal Investigator: James D Guest, MD, PhD University of Miami
Principal Investigator: Sven M Hochheimer, MD Brooke Army Medical Center
Principal Investigator: Graham H Creasey, MD Stanford University
Principal Investigator: Jason D Wilson, MD Louisiana State University, New Orleans
The Methodist Hospital System
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP