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Trial record 50 of 317 for:    Recruiting, Not yet recruiting, Available Studies | "Brain Injuries, Traumatic"

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 : Recruiting
First Posted : May 11, 2016
Last Update Posted : February 8, 2018
Sponsor:
Information provided by (Responsible Party):
Georgene Hergenroeder, The University of Texas Health Science Center, Houston

November 19, 2015
May 11, 2016
February 8, 2018
December 2015
December 2035   (Final data collection date for primary outcome measure)
  • 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
  • Disability Rating Scale [ Time Frame: greater than 6 months post-injury ]
    functional outcome scale for brain injury subjects
Same as current
Complete list of historical versions of study NCT02769416 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The National Center for Testing Treatments in Chronic Spinal Cord and Traumatic Brain Injury
The National Center for Testing Treatments in Chronic Spinal Cord and Traumatic Brain Injury
The NCTT is a prospective, multicenter, observational research network for subjects with chronic spinal cord and/or chronic traumatic brain injury.
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.
Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
5 Years
Retention:   Samples With DNA
Description:
Blood, urine, and saliva
Non-Probability Sample
Chronic spinal cord and traumatic brain injury patients, family members, and healthy vounteers
  • Spinal Cord Injury
  • Traumatic Brain Injury
Other: Data and sample repository
Subjects with spinal cord and/or traumatic brain injury, family members and healthy volunteers will provide data and samples.
  • 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.
    Intervention: Other: Data and sample repository
  • Family Members and Healthy Volunteers
    Healthy volunteer controls or family members may be enrolled for identification of genetic mutations.
    Intervention: Other: Data and sample repository
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
5000
Same as current
December 2035
December 2035   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Yes
Contact: Elena E Viverette, MS, RN, CCRC 713-500-6936 Elena.E.Viverette@uth.tmc.edu
United States
 
 
NCT02769416
HSC-MS-15-0705
No
Not Provided
Plan to Share IPD: No
Plan Description: IPD data will not be freely available. Participating centers will share data.
Georgene Hergenroeder, The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
Not Provided
Principal Investigator: Dong H Kim, MD UTHealth; Mischer Neuroscience Institute
The University of Texas Health Science Center, Houston
February 2018