Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-02-26 @ 7:24 PM
Study NCT ID:
NCT02728960
Status:
WITHDRAWN
Last Update Posted:
2019-05-10
First Post:
2016-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Traumatic Brain Injury Biological Diagnosis Via High Definition Tractography Asymmetry Screening
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}], 'ancestors': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study under review. Temporarily suspended', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-08', 'studyFirstSubmitDate': '2016-03-08', 'studyFirstSubmitQcDate': '2016-03-30', 'lastUpdatePostDateStruct': {'date': '2019-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnosis reliability measured by MRI scanning data results', 'timeFrame': '2 Hours'}, {'measure': 'Amount of white matter damage using HDTAS DSI diffusion evaluation of volume and connectivity across 40 fiber tracts over 150 brain regions.', 'timeFrame': '2 Hours', 'description': 'Tract anomalies will be coded as significant differences either to normative data of the tract or expected left/right ratio of tract axonal volume. White matter damage will first be quantified through HDFT evaluation of volume and connectivity across 40 fiber tracts over 150 brain regions'}, {'measure': 'Comparison of severity of subjects with TBI using Diffusion Tension Imaging (DTI)', 'timeFrame': '2 Hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Traumatic Brain Injury']}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to validate the High Definition Fiber Tracking (HDFT/HDFTAS) technology, so that faster, more reliable diagnosis can be implemented in Traumatic Brain Injury (TBI). This study will involve Traumatic Brain Injury Patients and normal controls, in addition to 30 pilot participants who will be undergoing MRI in order to develop a statistically sound range for the metrics derived from HDFT.', 'detailedDescription': 'This descriptive study sponsored by the United States Department of Defense involves the examination of TBI participants and normal control participants through MRI (Without Contrast) scanning. Normal controls are essential to develop a statistically sound range for the metrics derived from High Definition Fiber Tracking (HDFT). TBI subjects will undergo 1 MRI scan and normal controls will be asked to undergo 1 MRI scan. The study will involve blinded evaluations of results to determine the ability of HDFT imaging methods to evaluate TBI.\n\nIn addition to the TBI and normal controls evaluated in this research study, investigators will be running 30 pilot participants. These participants will be undergoing MRI in order to streamline our pulse sequence and calibrate the MRIs. This is part of the technical development for the project and will occur before the recruitment of TBI subjects and normal controls for comparison. Data from the pilot subjects will not serve as control data for the TBI subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria TBI subjects:\n\n* Documented history of TBI (for Chronic).\n* No MRI contraindications such as implanted ferrous metal, pacemakers, body weight above 125 Kg, (might not fit in the scanner), or concerns about claustrophobia.\n\nExclusion Criteria TBI subjects:\n\n* Inability or unwillingness of subject to provide written informed consent.\n* History of penetrating gunshot wound.\n\nInclusion Criteria Control subjects:\n\n* No prior history of concussion, TBI, blast exposure, stroke, or other major neurological disorder.\n* No MRI contraindications such as implanted ferrous metal, pacemakers, body weight above 125 Kg, (might not fit in the scanner), or concerns about claustrophobia.\n\nExclusion Criteria TBI subjects:\n\n* Inability or unwillingness of subject to provide written informed consent.\n* History of concussions, stroke, or penetrating gunshot wound.\n\nInclusion Criteria Sequence Development Subjects:\n\n* No MRI contraindications such as implanted ferrous metal, pacemakers, body weight above 125 Kg, (might not fit in the scanner), or concerns about claustrophobia.\n\nExclusion Criteria Sequence Development Subjects:\n\n* Inability or unwillingness of subject to provide written informed consent\n* Contra-indication to MR imaging, such as ferrous metal, pacemakers, body weight above 125 Kg or concerns'}, 'identificationModule': {'nctId': 'NCT02728960', 'briefTitle': 'Traumatic Brain Injury Biological Diagnosis Via High Definition Tractography Asymmetry Screening', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'TBI Biological Diagnosis Via High Definition Tractography Asymmetry Screening', 'orgStudyIdInfo': {'id': '12-03539'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Traumatic Brain Injury', 'description': 'Documented history of Traumatic Brain Injury', 'interventionNames': ['Procedure: MRI of the Brain (No Contrast) Scan']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Normal Controls', 'description': 'No prior history of concussion, TBI, blast exposure, stroke, or other major neurological disorder', 'interventionNames': ['Procedure: MRI of the Brain (No Contrast) Scan']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sequence Development Volunteers', 'interventionNames': ['Procedure: MRI of the Brain (No Contrast) Scan']}], 'interventions': [{'name': 'MRI of the Brain (No Contrast) Scan', 'type': 'PROCEDURE', 'description': 'DSI data will be acquired on 3T Tim Trio System (Siemens) using a 32-channel coil', 'armGroupLabels': ['Normal Controls', 'Sequence Development Volunteers', 'Traumatic Brain Injury']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Fernando Boada, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York University Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}