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NCT02769416 Clinical Trial

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

Traumatic Brain Injury Clinical Trial

— NCTT  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT02769416
Other study ID # HSC-MS-15-0705
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date December 2015
Est. completion date December 2035

Study information
Verified date August 2023
Source The University of Texas Health Science Center, Houston
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 5000
Est. completion date December 2035
Est. primary completion date December 2035
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States The University of Texas Health Science Center at Houston Houston Texas

Sponsors (1)
Lead Sponsor Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary International Standard Neurological Classification of Spinal Cord Injury functional ability (sensory and motor) for spinal cord injury subjects greater than 6 months post-injury
Primary Disability Rating Scale functional outcome scale for brain injury subjects greater than 6 months post-injury
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