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NCT Number: NCT00178724

Spinal Cord Injury Registry - North American Clinical Trials Network

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.

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Key information

Conditions

Spinal Cord Injury Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Toronto/Toronto Western Hospital, Toronto, Ontario, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No treatment given

Other

Intervention is not given.

Primary outcomes

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

Study contacts

Contact information is provided by the study sponsor or research team.

Elizabeth G Toups, MSN, RN, CCRP

CONTACT

[email protected]

832-722-4055

Tanisha Bernhardt

CONTACT

713-441-3814

Sponsors and collaborators

Lead sponsor

Robert G. Grossman, MD

Other

Collaborators

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

Registry information

Official study title

Spinal Cord Injury Registry - North American Clinical Trials Network for Spinal Cord Injury

Acronym: NACTN

Important dates

Study start: 2005
Primary completion: 2025
Study completion: 2028
First posted: Sep 15, 2005
Registry last updated: Sep 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting