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Spinal Cord Injury Registry - North American Clinical Trials Network

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00178724
Acronym
NACTN
Enrollment
1500
Registered
2005-09-15
Start date
2005-07-31
Completion date
2028-07-31
Last updated
2020-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injury

Keywords

spinal cord injury, SCI, traumatic spinal cord injury, acute spinal cord injury, paralysis

Brief summary

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.

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.

Interventions

OTHERNo Treatment Given

Intervention is not given.

Sponsors

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

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
International Standards For Neurological Classification of Spinal Injury (ISNCSCI)Pre-operative, Post-operative, 2 weeks, Discharge, 3 months, 6 months, 12 months, 36 months and 48 monthsA neurological assessment and classification of a spinal cord injury

Countries

Canada, United States

Contacts

Primary ContactElizabeth G Toups, MSN, RN, CCRP
etoups@houstonmethodist.org832-722-4055
Backup ContactTanisha Bernhardt
713-441-3814

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026