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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Elena E Viverette, MS, RN, CCRC	713-500-6936	Elena.E.Viverette@uth.tmc.edu

Locations

United States, Texas
The University of Texas Health Science Center at Houston	Recruiting
Houston, Texas, United States, 77030
Contact: Elena E Viverette, MS, RN, CCRC 713-500-6936 Elena.E.Viverette@uth.tmc.edu

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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Vivian L. Smith Department of Neurosurgery/Research 

Mischer Neuroscience Institute 

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
Last Update Posted:	February 8, 2018
Last Verified:	February 2018
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