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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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.
TEAM-TBI (Targeted Evaluation, Action, and Monitoring of Traumatic Brain Injury) proposes a new approach to clinical trials in TBI that will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| History of Traumatic Brain Injury | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive/Neuropsychological Testing | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Satisfaction with Life Scale | Up to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh Neurotrauma Clinical Trials Center | Pittsburgh | Pennsylvania | 15213 | United States |
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| Vestibular/Ocular-Motor Testing | Other | 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. |
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| Cervical (Neck) Evaluation | Other | These assessments will involve a series of tests and questionnaires that focus on physical symptoms of TBI including neck mobility and pain levels. |
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| Sleep Evaluation | Other | These evaluations will focus on assessing insomnia (duration, frequency, daytime consequences), combat exposure, and the presence and severity of trauma history. |
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| HDFT MRI | Other | This MRI aims at providing qualitative and quantitative assessments of the nature, location, and extent of white matter injury. |
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| MR Spectroscopy (MRS) | Other | This is a noninvasive diagnostic test for measuring biochemical changes in the brain. |
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| MEG (Magnetoencephalography) | Other | This is a non-invasive neurophysiological technique that measures the magnetic fields generated by neuronal activity of the brain. |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D009483 | Neuropsychological Tests |
| D009682 | Magnetic Resonance Spectroscopy |
| D015225 | Magnetoencephalography |
| ID | Term |
|---|---|
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D003943 | Diagnostic Techniques, Neurological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004568 | Electrodiagnosis |
| D060306 | Magnetometry |
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