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

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ClinicalTrials.gov Identifier: NCT02769416
Recruitment Status : Enrolling by invitation
First Posted : May 11, 2016
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Georgene Hergenroeder, The University of Texas Health Science Center, Houston

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

Condition or disease Intervention/treatment
Spinal Cord Injury Traumatic Brain Injury Other: Data and sample repository

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.

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: The National Center for Testing Treatments in Chronic Spinal Cord and Traumatic Brain Injury
Actual Study Start Date : December 2015
Estimated Primary Completion Date : December 2035
Estimated Study Completion Date : December 2035

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Spinal Cord and Traumatic Brain Injury Subjects
Patients with a history of spinal cord and/or traumatic brain injury will provide data and samples so that they may be queried for interventional studies.
 Other: Data and sample repository
Subjects with spinal cord and/or traumatic brain injury, family members and healthy volunteers will provide data and samples.
Family Members and Healthy Volunteers
Healthy volunteer controls or family members may be enrolled for identification of genetic mutations.
 Other: Data and sample repository
Subjects with spinal cord and/or traumatic brain injury, family members and healthy volunteers will provide data and samples.


Outcome Measures
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Primary Outcome Measures :
  1. International Standard Neurological Classification of Spinal Cord Injury [ Time Frame: greater than 6 months post-injury ]
    functional ability (sensory and motor) for spinal cord injury subjects

  2. Disability Rating Scale [ Time Frame: greater than 6 months post-injury ]
    functional outcome scale for brain injury subjects


Biospecimen Retention:   Samples With DNA
Blood, urine, and saliva

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Chronic spinal cord and traumatic brain injury patients, family members, and healthy vounteers
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02769416


Locations
United States, Texas
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Dong H Kim, MD UTHealth; Mischer Neuroscience Institute
More Information
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Additional Information:
Vivian L. Smith Department of Neurosurgery/Research  This link exits the ClinicalTrials.gov site
Mischer Neuroscience Institute  This link exits the ClinicalTrials.gov site

Responsible Party: Georgene Hergenroeder, Study Director, Co-PI, Assistant Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02769416     History of Changes
Other Study ID Numbers: HSC-MS-15-0705
First Posted: May 11, 2016    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD data will not be freely available. Participating centers will share data.

Keywords provided by Georgene Hergenroeder, The University of Texas Health Science Center, Houston:
spinal cord injury
traumatic brain injury

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