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

September 22, 2020 updated by: Robert G. Grossman, MD

Spinal Cord Injury Registry - North American Clinical Trials Network for 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, intensive monitoring and frequent follow up care.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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; Thomas Jefferson University, Philadelphia; University of Miami, Miami; Brooke Army Medical Center, Fort Sam Houston; Louisiana State University Health Sciences Center, New Orleans; Vanderbilt University Medical Center, Nashville; Medical College Wisconsin, Milwaukee; Duke University, Durham

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.

Study Type

Observational

Enrollment (Anticipated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Tanisha Bernhardt
  • Phone Number: 713-441-3814

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T-2S8
        • Recruiting
        • University of Toronto/Toronto Western Hospital
        • Contact:
        • Principal Investigator:
          • Michael G Fehlings, MD, PhD
  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami
        • Contact:
        • Principal Investigator:
          • James D Guest, MD, PhD
    • Kentucky
      • Louisville, Kentucky, United States, 40205
        • Active, not recruiting
        • University of Louisville Health Sciences Center
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • Louisiana State University Medical Sciences Center in New Orleans
        • Principal Investigator:
          • Jason D Wilson, MD
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland Medical Center
        • Contact:
        • Principal Investigator:
          • Bizhan Aarabi, MD
      • Bethesda, Maryland, United States, 20889
        • Recruiting
        • Walter Reed National Military Medical Center
        • Contact:
        • Principal Investigator:
          • Christopher J Neal, MD
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Not yet recruiting
        • Duke University
        • Contact:
        • Sub-Investigator:
          • Muhammad Abd-El-Barr, MD, PhD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thomas Jefferson University
        • Contact:
        • Principal Investigator:
          • James S Harrop, MD
    • Tennessee
      • Nashville, Tennessee, United States, 37240
        • Not yet recruiting
        • Hamid Shah, MD
        • Contact:
        • Principal Investigator:
          • Hamid Shah, MD
    • Texas
      • Fort Sam Houston, Texas, United States, 78234
        • Active, not recruiting
        • Brooke Army Medical Center
      • Houston, Texas, United States, 77030
        • Active, not recruiting
        • Houston Methodist Hospital
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas, Houston
        • Contact:
        • Principal Investigator:
          • Karl Schmitt, MD
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Recruiting
        • University of Virginia Health System
        • Contact:
        • Principal Investigator:
          • Chun-Po Yen, MD
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Not yet recruiting
        • Medical College of Wisconsin
        • Contact:
        • Principal Investigator:
          • Shekar N Kurpad, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Admitted to a NACTN hospital through the Emergency Department at the time of injury.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Pre-operative, Post-operative, 2 weeks, Discharge, 3 months, 6 months, 12 months, 36 months and 48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Robert G. Grossman, MD

Collaborators

The University of Texas Health Science Center, Houston
University of Maryland, Baltimore
University of Miami
Duke University
Medical College of Wisconsin
Vanderbilt University Medical Center
University of Toronto
University of Virginia
Louisiana State University Health Sciences Center in New Orleans
Thomas Jefferson University
Walter Reed National Military Medical Center
University of Louisville
The Methodist Hospital Research Institute
Brooke Army Medical Center
Christopher Reeve Paralysis Foundation

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: Emily Sieg, MD, University of Louisville, Louisville
  • Principal Investigator: Bizhan Aarabi, MD, University of Maryland Medical Center, Baltimore Shock Trauma Center
  • Principal Investigator: Chun-Po Yen, MD, University of Virginia Health System, Charlottesville
  • Principal Investigator: Christopher J Neal, MD, Walter Reed National Military Medical Center, Bethesda
  • Principal Investigator: James S Harrop, MD, Thomas Jefferson University, Philadelphia
  • Principal Investigator: James D Guest, MD, PhD, University of Miami, Miami
  • Principal Investigator: Ryan P Morton, MD, Brooke Army Medical Center, Fort Sam Houston
  • Principal Investigator: Jason D Wilson, MD, Louisiana State University Health Sciences Center in New Orleans
  • Principal Investigator: Hamid Shah, MD, Vanderbilt University Medical Center, Nashville
  • Principal Investigator: Shekar N Kurpad, MD, PhD, Medical College of Wisconsin, Milwaukee
  • Principal Investigator: Christopher I Shaffrey, MD, Duke University, Durham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Anticipated)

July 1, 2025

Study Completion (Anticipated)

July 1, 2028

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Actual)

September 24, 2020

Last Update Submitted That Met QC Criteria

September 22, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00002187
  • W81XWH-16-C-0031 (Other Grant/Funding Number: Department of Defense)
  • CTN16-2020(RG) (Other Identifier: NACTN)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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