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Spinal Cord Injury Registry - NACTN (NACTN)

This study is currently recruiting participants.
Verified September 2017 by Robert G. Grossman, MD, The Methodist Hospital System
Sponsor:
ClinicalTrials.gov Identifier:
NCT00178724
First Posted: September 15, 2005
Last Update Posted: September 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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
Louisiana State University Health Sciences Center in New Orleans
Vanderbilt University Medical Center
Information provided by (Responsible Party):
Robert G. Grossman, MD, The Methodist Hospital System
  Purpose
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, intensive monitoring and frequent follow up care.

Condition Intervention
Spinal Cord Injury Other: No Treatment Given

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Prospective
Official Title: Spinal Cord Injury Registry - North American Clinical Trials Network for Spinal Cord Injury

Resource links provided by NLM:


Further study details as provided by Robert G. Grossman, MD, The Methodist Hospital System:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 1500
Study Start Date: July 2005
Estimated Study Completion Date: July 2023
Estimated Primary Completion Date: July 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
No Treatment Given
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 (muscle weakness) or loss of sensation (touch). The patient has not received medical or surgical care for this injury prior to admission to a NACTN hospital. Patient or family member must give consent to participate.
Other: No Treatment Given
Intervention is not given.

Detailed Description:

The participating centers include:

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; Louisiana State University Health Sciences Center in New Orleans Vanderbilt University Medical Center

The NACTN Clinical Coordinating Center is located at:

Houston Methodist Hospital, Houston

The Center for Biostatistics is located at:

Houston Methodist Hospital, Houston

The Data Management Center is located at:

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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Admitted to a NACTN hospital through the Emergency Department at the time of injury.
Criteria

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 with paralysis (weakness) or loss of sensation (touch).
  • Has not received prior medical of surgical care for this injury at an intermediate hospital.
  • Must give informed consent

Exclusion Criteria:

  • Any patient or family refusing consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00178724


Contacts
Contact: Elizabeth G Toups, MS, RN, CCRP 832-722-4055 etoups@houstonmethodist.org
Contact: Tanisha Bernhardt 713-441-3814

Locations
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: George Jimsheleishvihi, MD    305-243-4781    gxj150@miami.edu   
Principal Investigator: James D Guest, M.D., PhD         
United States, Kentucky
University of Louisville Health Sciences Center Recruiting
Louisville, Kentucky, United States, 40205
Contact: Lori Clark    502-333-8140    LoriClark2@KentuckyOneHealth.org   
Principal Investigator: Maxwell Boakye, MD         
United States, Louisiana
Louisiana State University Medical Sciences Center in New Orleans Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Erin Fannin, MSPH    504-568-2641    efanni@lsuhsc.edu   
Principal Investigator: Jason D Wilson, MD         
United States, Maryland
University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Charlene Aldrich, RN, MSN    410-328-5332    caldrich@smail.umaryland.edu   
Principal Investigator: Bizhan Aarabi, MD         
Walter Reed National Military Medical Center Recruiting
Bethesda, Maryland, United States, 20889
Contact: Ellen Tasikas    301-295-8991    ellen.m.tasikas.ctr@mail.mil   
Principal Investigator: Christopher J Neal, MD         
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Kara Pigott, MS    215-503-9110    Kara.Pigott@jefferson.edu   
Principal Investigator: James S Harrop, MD         
United States, Tennessee
Hamid Shah, MD Not yet recruiting
Nashville, Tennessee, United States, 37240
Contact: Melba Isom    615-875-5853    melba.isom@vanderbilt.edu   
Principal Investigator: Hamid Shah, MD         
United States, Texas
Brooke Army Medical Center Recruiting
Fort Sam Houston, Texas, United States, 78234
Contact: Amy Guthrie    210-916-3482    Amy.e.guthrie.ctr@mail.mil   
Principal Investigator: Sven M Hochheimer, MD         
Houston Methodist Hospital Active, not recruiting
Houston, Texas, United States, 77030
The University of Texas, Houston Recruiting
Houston, Texas, United States, 77030
Contact: Elena Viverette, MS RN    713-500-6141    Elena.E.Viverette@uth.tmc.edu   
Principal Investigator: Karl Schmitt, MD         
United States, Virginia
University of Virginia Health System Recruiting
Charlottesville, Virginia, United States, 22903
Contact: Judy Beenhakker, MS    434-982-1856    JBB3P@hscmail.mcc.virginia.edu   
Principal Investigator: Christopher I Shaffrey, MD         
Canada, Ontario
University of Toronto/Toronto Western Hospital Recruiting
Toronto, Ontario, Canada, M5T-2S8
Contact: Yuliya Petrenko, MD    416-603-5285    Yuliya.Petrenko@uhn.on.ca   
Principal Investigator: Michael G Fehlings, MD, PhD         
Sponsors and Collaborators
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
Louisiana State University Health Sciences Center in New Orleans
Vanderbilt University Medical Center
Investigators
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: Jason D Wilson, MD Louisiana State University Health Sciences Center in New Orleans
Principal Investigator: Hamid Shah, MD Vanderbilt University Medical Center
  More Information

Additional Information:
Responsible Party: Robert G. Grossman, MD, Professor, Department of Neurosurgery, The Methodist Hospital System
ClinicalTrials.gov Identifier: NCT00178724     History of Changes
Other Study ID Numbers: Pro00002187
W81XH-13-2-0040 ( Other Grant/Funding Number: Department of Defense )
CTN11-2015(RG) ( Other Identifier: NACTN )
First Submitted: September 13, 2005
First Posted: September 15, 2005
Last Update Posted: September 13, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Robert G. Grossman, MD, The Methodist Hospital System:
spinal cord injury
SCI
traumatic spinal cord injury
acute spinal cord injury
paralysis

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System


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