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
• Status: Enrolling by invitation
• 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
• 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).

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Spinal Cord Injuries
• Spinal Cord Injury
• Traumatic Brain Injury
• Wounds and Injuries

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