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

• Conditions: Spinal Cord Injury; Traumatic Brain Injury
• Interventions: Other: Data and sample repository

• Registration Number: NCT02769416
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

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.

Study Timeline

• Study First Submitted: 2015-11-19
• Study Start: 2015-12
• Study First Submitted QC: 2016-05-10
• Study First Posted: 2016-05-11
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-22
• Last Update Posted: 2024-08-26
• Primary Completion: 2035-12
• Study Completion: 2035-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 5000

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Family Members and Healthy Volunteers	Data and sample repository	Healthy volunteer controls or family members may be enrolled for identification of genetic mutations.
Spinal Cord and Traumatic Brain Injury Subjects	Data and sample repository	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.

Primary Outcome Measures

Name	Time	Method
International Standard Neurological Classification of Spinal Cord Injury	greater than 6 months post-injury	functional ability (sensory and motor) for spinal cord injury subjects
Disability Rating Scale	greater than 6 months post-injury	functional outcome scale for brain injury subjects

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States