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

Sponsor

The University of Texas Health Science Center, Houston (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT02769416

Collaborator

(none)

5,000

Enrollment

Location

240

Anticipated Duration (Months)

20.8

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

5000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Dec 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2035

Anticipated Study Completion Date :

Dec 1, 2035

Arms and Interventions

Arm	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.

Arm

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

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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).