Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2026-02-26 @ 4:30 PM
Study NCT ID:
NCT02769416
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-08-07
First Post:
2015-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The National Center for Testing Treatments in Chronic Spinal Cord and Traumatic Brain Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood, urine, and saliva'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2035-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-05', 'studyFirstSubmitDate': '2015-11-19', 'studyFirstSubmitQcDate': '2016-05-10', 'lastUpdatePostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2035-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'International Standard Neurological Classification of Spinal Cord Injury', 'timeFrame': 'greater than 6 months post-injury', 'description': 'functional ability (sensory and motor) for spinal cord injury subjects'}, {'measure': 'Disability Rating Scale', 'timeFrame': 'greater than 6 months post-injury', 'description': 'functional outcome scale for brain injury subjects'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['spinal cord injury', 'traumatic brain injury'], 'conditions': ['Spinal Cord Injury', 'Traumatic Brain Injury']}, 'descriptionModule': {'briefSummary': 'The NCTT is a prospective, multicenter, observational research network for subjects with chronic spinal cord and/or chronic traumatic brain injury.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Chronic spinal cord and traumatic brain injury patients, family members, and healthy vounteers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History of spinal cord injury and/or brain injury\n* Able to provide HIPAA authorization to share prior medical records/imaging\n* Age 18 and older.\n\nExclusion Criteria:\n\n* 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.\n* Other condition that, in the opinion of the site investigator, would interfere with adherence to study requirements.\n* Inability or unwillingness of subject or legal guardian/representative to give informed consent (e.g., ward of the state).'}, 'identificationModule': {'nctId': 'NCT02769416', 'acronym': 'NCTT', 'briefTitle': 'The National Center for Testing Treatments in Chronic Spinal Cord and Traumatic Brain Injury', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'The National Center for Testing Treatments in Chronic Spinal Cord and Traumatic Brain Injury', 'orgStudyIdInfo': {'id': 'HSC-MS-15-0705'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Spinal Cord and Traumatic Brain Injury Subjects', 'description': '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.', 'interventionNames': ['Other: Data and sample repository']}, {'label': 'Family Members and Healthy Volunteers', 'description': 'Healthy volunteer controls or family members may be enrolled for identification of genetic mutations.', 'interventionNames': ['Other: Data and sample repository']}], 'interventions': [{'name': 'Data and sample repository', 'type': 'OTHER', 'description': 'Subjects with spinal cord and/or traumatic brain injury, family members and healthy volunteers will provide data and samples.', 'armGroupLabels': ['Family Members and Healthy Volunteers', 'Spinal Cord and Traumatic Brain Injury Subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Georgene Hergenroeder, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UTHealth'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD data will not be freely available. Participating centers will share data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Study Director, PI, Associate Professor', 'investigatorFullName': 'Georgene Hergenroeder', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}