NCT02769416

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
117mo left

Started Dec 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress52%
Dec 2015Dec 2035

First Submitted

Initial submission to the registry

November 19, 2015

Completed
12 days until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
5 months until next milestone

First Posted

Study publicly available on registry

May 11, 2016

Completed
19.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2035

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2035

Last Updated

August 7, 2025

Status Verified

August 1, 2025

Enrollment Period

20 years

First QC Date

November 19, 2015

Last Update Submit

August 5, 2025

Conditions

Keywords

spinal cord injurytraumatic brain injury

Outcome Measures

Primary Outcomes (2)

  • International Standard Neurological Classification of Spinal Cord Injury

    functional ability (sensory and motor) for spinal cord injury subjects

    greater than 6 months post-injury

  • Disability Rating Scale

    functional outcome scale for brain injury subjects

    greater than 6 months post-injury

Study Arms (2)

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

Family Members and Healthy Volunteers

Healthy volunteer controls or family members may be enrolled for identification of genetic mutations.

Other: Data and sample repository

Interventions

Subjects with spinal cord and/or traumatic brain injury, family members and healthy volunteers will provide data and samples.

Family Members and Healthy VolunteersSpinal Cord and Traumatic Brain Injury Subjects

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • History of spinal cord injury and/or brain injury
  • Able to provide HIPAA authorization to share prior medical records/imaging
  • Age 18 and older.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine, and saliva

MeSH Terms

Conditions

Spinal Cord InjuriesBrain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesBrain InjuriesBrain DiseasesCraniocerebral Trauma

Study Officials

  • Georgene Hergenroeder, PhD

    UTHealth

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Director, PI, Associate Professor

Study Record Dates

First Submitted

November 19, 2015

First Posted

May 11, 2016

Study Start

December 1, 2015

Primary Completion (Estimated)

December 1, 2035

Study Completion (Estimated)

December 1, 2035

Last Updated

August 7, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

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

Locations