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Enrolling by invitation NCT02769416

The National Center for Testing Treatments in Chronic Spinal Cord and Traumatic Brain Injury

Observational Spinal Cord Injury Traumatic Brain Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Data and sample repository.
Who it may be relevant to
Registry conditions: Spinal Cord Injury, Traumatic Brain Injury. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

The NCTT is a prospective, multicenter, observational research network for subjects with chronic spinal cord and/or chronic traumatic brain injury.

Detailed description

Current treatment for Spinal Cord Injury and Traumatic Brain Injury focuses on stabilizing the patient and preventing secondary injury with the aim of maximizing the best chance of recovery. Most patients will show varying amounts of recovery, but, when the injury is severe, that recovery is only partial. Enrollment in the NCTT will allow for classification and characterization of injury, function, co-morbidities, secondary issues/problems, research interests and will serve as a conduit for enrollment into interventional studies.

Interventions

  • Other Data and sample repository
    Subjects with spinal cord and/or traumatic brain injury, family members and healthy volunteers will provide data and samples.

Primary outcome measures

  • International Standard Neurological Classification of Spinal Cord Injury [Time frame: greater than 6 months post-injury]
  • Disability Rating Scale [Time frame: greater than 6 months post-injury]

Eligibility criteria

Inclusion criteria

  • History of spinal cord injury and/or brain injury
  • Able to provide HIPAA authorization to share prior medical records/imaging
  • Age 18 and older.

Exclusion criteria

  • Life expectancy less than 6 months, vegetative state or co-existing disease or other characteristic that precludes appropriate diagnosis of spinal cord or brain injury.
  • Other condition that, in the opinion of the site investigator, would interfere with adherence to study requirements.
  • Inability or unwillingness of subject or legal guardian/representative to give informed consent (e.g., ward of the state).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • The University of Texas Health Science Center at Houston — Houston

Identifiers

NCT: NCT02769416 · HSC-MS-15-0705

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗