Targeted Evaluation, Action, & Monitoring of Traumatic Brain Injury
NCT ID: NCT02657135
Last Updated: 2018-07-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
95 participants
INTERVENTIONAL
2014-03-24
2018-03-23
Brief Summary
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Detailed Description
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* Evolve diagnostic technology \& treatment
* Improve self-help strategies
* Lower cost and speed for delivery of effective strategies
The 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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History of Traumatic Brain Injury
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.
Cognitive/Neuropsychological Testing
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.
Vestibular/Ocular-Motor Testing
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.
Cervical (Neck) Evaluation
These assessments will involve a series of tests and questionnaires that focus on physical symptoms of TBI including neck mobility and pain levels.
Sleep Evaluation
These evaluations will focus on assessing insomnia (duration, frequency, daytime consequences), combat exposure, and the presence and severity of trauma history.
HDFT MRI
This MRI aims at providing qualitative and quantitative assessments of the nature, location, and extent of white matter injury.
MR Spectroscopy (MRS)
This is a noninvasive diagnostic test for measuring biochemical changes in the brain.
MEG (Magnetoencephalography)
This is a non-invasive neurophysiological technique that measures the magnetic fields generated by neuronal activity of the brain.
Interventions
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Cognitive/Neuropsychological Testing
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.
Vestibular/Ocular-Motor Testing
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.
Cervical (Neck) Evaluation
These assessments will involve a series of tests and questionnaires that focus on physical symptoms of TBI including neck mobility and pain levels.
Sleep Evaluation
These evaluations will focus on assessing insomnia (duration, frequency, daytime consequences), combat exposure, and the presence and severity of trauma history.
HDFT MRI
This MRI aims at providing qualitative and quantitative assessments of the nature, location, and extent of white matter injury.
MR Spectroscopy (MRS)
This is a noninvasive diagnostic test for measuring biochemical changes in the brain.
MEG (Magnetoencephalography)
This is a non-invasive neurophysiological technique that measures the magnetic fields generated by neuronal activity of the brain.
Eligibility Criteria
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Inclusion Criteria
* Fluent in English
* Documented history of TBI or blast exposure since 2001
Exclusion Criteria
* Pregnancy
* History of TIA within last 6 months.
* Presently involved in open litigation
18 Years
60 Years
ALL
No
Sponsors
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United States Department of Defense
FED
University of Pittsburgh
OTHER
Responsible Party
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David Okonkwo, MD, Phd
Professor
Locations
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University of Pittsburgh Neurotrauma Clinical Trials Center
Pittsburgh, Pennsylvania, United States
Countries
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Other Identifiers
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W81XWH-14-2-0002
Identifier Type: -
Identifier Source: org_study_id
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