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

August 28, 2023 updated by: Georgene Hergenroeder, The University of Texas Health Science Center, Houston
The NCTT is a prospective, multicenter, observational research network for subjects with chronic spinal cord and/or chronic traumatic brain injury.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Chronic spinal cord and traumatic brain injury patients, family members, and healthy vounteers

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
greater than 6 months post-injury
Disability Rating Scale
Time Frame: greater than 6 months post-injury
functional outcome scale for brain injury subjects
greater than 6 months post-injury

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Investigators

  • Principal Investigator: Georgene Hergenroeder, PhD, UTHealth

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2015

Primary Completion (Estimated)

December 1, 2035

Study Completion (Estimated)

December 1, 2035

Study Registration Dates

First Submitted

November 19, 2015

First Submitted That Met QC Criteria

May 10, 2016

First Posted (Estimated)

May 11, 2016

Study Record Updates

Last Update Posted (Actual)

August 29, 2023

Last Update Submitted That Met QC Criteria

August 28, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-MS-15-0705

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD data will not be freely available. Participating centers will share data.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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