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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 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
Information provided by (Responsible Party):
Robert G. Grossman, MD, The Methodist Hospital System
ClinicalTrials.gov Identifier:
NCT00178724
First received: September 13, 2005
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

The NACTN Registry is a network of clinical centers collecting standardized de-identified data from patients presenting with a new traumatic spinal cord injury(SCI). Information will be collected on the natural history of SCI and course of treatment through the first 12 months following the date of injury. Data collected includes imaging information from CT or MRI scans, neurological and general medical outcome and rehabilitation evaluation.


Condition Phase
Spinal Cord Injury
Phase 1

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: North American Clinical Trials Network (NACTN) for Treatment of Spinal Cord Injury

Resource links provided by NLM:


Further study details as provided by The Methodist Hospital System:

Primary Outcome Measures:
  • American Spinal Injury Association Impairment Scale [ Time Frame: Pre-operative, Post-operative, 2 weeks, Discharge, 3 months, 6 months, 12 months, 36 months and 48 months ] [ Designated as safety issue: Yes ]
    A neurological assessment and classification of a spinal cord injury


Estimated Enrollment: 500
Study Start Date: July 2005
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Any male or female 18 years or older admitted to a NACTN hospital with an initial traumatic spinal cord injury (within 2 weeks of injury) and has neurological deficit. The patient has not received medical care for this injury prior to admission except for care at an intermediate hospital.

Detailed Description:

The participating centers include:

The 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, Washington District of Columbia; Thomas Jefferson University,Philadelphia; University of Miami, Miami

The Biostatistics and Analytical Center 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Admitted to a NACTN hospital

Criteria

Inclusion Criteria:

  • Any patient male or female > or equal to 18 years of age with an initial traumatic spinal cord injury and neurological deficit (motor weakness/paralysis or loss of sensation).
  • Must give informed consent

Exclusion Criteria:

  • Any patient/family refusing consent
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00178724

Contacts
Contact: Elizabeth Toups, MS, RN, CCRP 713-441-3897 etoups@tmhs.org

Locations
United States, District of Columbia
Walter Reed National Military Medical Center Recruiting
Washington, District of Columbia, United States, 20307
Contact: Vicki J. Miskovsky    301-295-8991    vicki.j.miskovskyctr@health.mil   
Principal Investigator: Michael Rosner, MD         
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Marina Dididze, M.D., PhD    305-243-4781    MDididze@med.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: Chike Ilorah, MPH, MD    502-821-9870    cailor01@louisville.edu   
Principal Investigator: Susan Harkema, PhD         
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         
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Melissa Witt    215-503-5739    Melissa.witt@jefferson.edu   
Principal Investigator: James S Harrop, MD         
United States, Texas
The University of Texas, Houston Recruiting
Houston, Texas, United States, 77030
Contact: Martha Powner, MS RN    713-500-6936    Martha.Powner@uth.tmc.edu   
Principal Investigator: Michele M Johnson, MD         
Houston Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Elizabeth Toups, MSN, CCRP    713-441-3897    etoups@tmhs.org   
Principal Investigator: Robert G Grossman, MD         
Brooke Army Medical Center Recruiting
San Antonio, Texas, United States, 78234
Contact: Shalece Kofford, RN, MPH    210-916-4400    Shalece.kofford.ctr@amedd.army.mil   
Principal Investigator: Joseph K Hobbs, MD         
United States, Virginia
University of Virginia Health System Recruiting
Charlottesville, Virginia, United States, 22903
Contact: Amy Halpin, BS    434-243-7336    abh3b@virginia.edu   
Principal Investigator: Christopher 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 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
Investigators
Study Chair: Robert G Grossman, MD Hoiuston Methodist Hospital, Houston
Principal Investigator: Michele M Johnson, MD The University of Texas, Houston
Principal Investigator: Michael 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 Shaffrey, MD University of Virginia Health System, Charlottesville
Principal Investigator: Michael Rosner, 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: Joseph H Hobbs, MD Brooke Army Medical Center
  More Information

Additional Information:
No publications provided

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: CTN1-2004(RG), W81XH-13-1-0040
Study First Received: September 13, 2005
Last Updated: July 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by The Methodist Hospital System:
spinal cord injury
SCI
traumatic spinal cord injury
acute spinal cord injury

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

ClinicalTrials.gov processed this record on October 23, 2014