The National Center for Testing Treatments in Chronic Spinal Cord and Traumatic Brain Injury (NCTT)
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Contacts and Locations
Study Locations
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Texas
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Houston, Texas, United States, 77030
- The University of Texas Health Science Center at Houston
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
Number of groups / cohorts
Cohorts and Interventions
Group / CohortGroup / Cohort |
Intervention / TreatmentIntervention / 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.
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Subjects with spinal cord and/or traumatic brain injury, family members and healthy volunteers will provide data and samples.
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Family Members and Healthy Volunteers
Healthy volunteer controls or family members may be enrolled for identification of genetic mutations.
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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
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
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functional ability (sensory and motor) for spinal cord injury subjects
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greater than 6 months post-injury
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Disability Rating Scale
Time Frame: greater than 6 months post-injury
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functional outcome scale for brain injury subjects
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greater than 6 months post-injury
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Georgene Hergenroeder, PhD, UTHealth
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimated)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- HSC-MS-15-0705
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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