Ignite Creation Date:
2025-12-24 @ 10:20 PM
Ignite Modification Date:
2026-01-05 @ 12:03 PM
Study NCT ID:
NCT02657135
Status:
COMPLETED
Last Update Posted:
2018-07-23
First Post:
2015-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Targeted Evaluation, Action, & Monitoring of Traumatic Brain Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009483', 'term': 'Neuropsychological Tests'}, {'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}, {'id': 'D015225', 'term': 'Magnetoencephalography'}], 'ancestors': [{'id': 'D011581', 'term': 'Psychological Tests'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003943', 'term': 'Diagnostic Techniques, Neurological'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004568', 'term': 'Electrodiagnosis'}, {'id': 'D060306', 'term': 'Magnetometry'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 95}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-03-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-19', 'studyFirstSubmitDate': '2015-07-16', 'studyFirstSubmitQcDate': '2016-01-14', 'lastUpdatePostDateStruct': {'date': '2018-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The main outcome variable in the study will be the change in Post-Concussion Symptom Scale (PCSS) score from the initial intake evaluation compared to last follow-up evaluation.', 'timeFrame': 'Up to 6 months'}], 'secondaryOutcomes': [{'measure': 'Change in the Satisfaction with Life Scale', 'timeFrame': 'Up to 6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Traumatic Brain Injury (TBI)']}, 'descriptionModule': {'briefSummary': 'TEAM-TBI (Targeted Evaluation, Action, and Monitoring of Traumatic Brain Injury) is a research study that brings together TBI patients, advanced evaluation methods, and experts in a multi-faceted study to address the heterogeneity of TBI and to evaluate the effects self-help strategies might have on TBI outcomes.', 'detailedDescription': 'TEAM-TBI (Targeted Evaluation, Action, and Monitoring of Traumatic Brain Injury) proposes a new approach to clinical trials in TBI that will:\n\n* Evolve diagnostic technology \\& treatment\n* Improve self-help strategies\n* Lower cost and speed for delivery of effective strategies\n\nThe TEAM-TBI program proposes an innovative new approach to TBI clinical trials to overcome the limitations of past efforts and achieve long-awaited breakthroughs for TBI survivors. The study will involve a comprehensive 3-4 day intake evaluation, followed by a variety of remotely performed tasks during a 1-6 month follow-up period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-60 years of age\n* Fluent in English\n* Documented history of TBI or blast exposure since 2001\n\nExclusion Criteria:\n\n* Inability to have MRI\n* Pregnancy\n* History of TIA within last 6 months.\n* Presently involved in open litigation'}, 'identificationModule': {'nctId': 'NCT02657135', 'acronym': 'TEAM-TBI', 'briefTitle': 'Targeted Evaluation, Action, & Monitoring of Traumatic Brain Injury', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Targeted Evaluation, Action, & Monitoring of Traumatic Brain Injury', 'orgStudyIdInfo': {'id': 'W81XWH-14-2-0002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'History of Traumatic Brain Injury', 'description': 'All participants have a history of TBI. At study outcome participants are provided treatment recommendations that are the result of a consensus meeting of all physician investigators. Follow up care is not provided by this clinical trial.', 'interventionNames': ['Behavioral: Cognitive/Neuropsychological Testing', 'Other: Vestibular/Ocular-Motor Testing', 'Other: Cervical (Neck) Evaluation', 'Other: Sleep Evaluation', 'Other: HDFT MRI', 'Other: MR Spectroscopy (MRS)', 'Other: MEG (Magnetoencephalography)']}], 'interventions': [{'name': 'Cognitive/Neuropsychological Testing', 'type': 'BEHAVIORAL', 'description': 'These tests will be used to determine how the participant will continue with future procedures, and depending on results, may involve the participant returning to complete subsequent testing.', 'armGroupLabels': ['History of Traumatic Brain Injury']}, {'name': 'Vestibular/Ocular-Motor Testing', 'type': 'OTHER', 'description': 'These assessments will involve a series of tests and questionnaires that focus on physical symptoms of TBI and will include dizziness, balance, ocular-motor coordination, and reflexes.', 'armGroupLabels': ['History of Traumatic Brain Injury']}, {'name': 'Cervical (Neck) Evaluation', 'type': 'OTHER', 'description': 'These assessments will involve a series of tests and questionnaires that focus on physical symptoms of TBI including neck mobility and pain levels.', 'armGroupLabels': ['History of Traumatic Brain Injury']}, {'name': 'Sleep Evaluation', 'type': 'OTHER', 'description': 'These evaluations will focus on assessing insomnia (duration, frequency, daytime consequences), combat exposure, and the presence and severity of trauma history.', 'armGroupLabels': ['History of Traumatic Brain Injury']}, {'name': 'HDFT MRI', 'type': 'OTHER', 'description': 'This MRI aims at providing qualitative and quantitative assessments of the nature, location, and extent of white matter injury.', 'armGroupLabels': ['History of Traumatic Brain Injury']}, {'name': 'MR Spectroscopy (MRS)', 'type': 'OTHER', 'description': 'This is a noninvasive diagnostic test for measuring biochemical changes in the brain.', 'armGroupLabels': ['History of Traumatic Brain Injury']}, {'name': 'MEG (Magnetoencephalography)', 'type': 'OTHER', 'description': 'This is a non-invasive neurophysiological technique that measures the magnetic fields generated by neuronal activity of the brain.', 'armGroupLabels': ['History of Traumatic Brain Injury']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Neurotrauma Clinical Trials Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Department of Defense', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'David Okonkwo, MD, Phd', 'investigatorAffiliation': 'University of Pittsburgh'}}}}