Targeted Evaluation, Action, & Monitoring of Traumatic Brain Injury

Study Overview
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Brief Summary
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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.

Detailed Description
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TEAM-TBI (Targeted Evaluation, Action, and Monitoring of Traumatic Brain Injury) proposes a new approach to clinical trials in TBI that will: 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.

Official Title
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Targeted Evaluation, Action, & Monitoring of Traumatic Brain Injury

Conditions
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Traumatic Brain Injury (TBI)

Intervention / Treatment
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* 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)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-60 years of age Fluent in English Documented history of TBI or blast exposure since 2001 Exclusion Criteria: Inability to have MRI Pregnancy History of TIA within last 6 months. Presently involved in open litigation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: History of Traumatic Brain Injury<br>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. | Behavioral: Cognitive/Neuropsychological Testing<br>* 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.<br>Other: Vestibular/Ocular-Motor Testing<br>* 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.<br>Other: Cervical (Neck) Evaluation<br>* These assessments will involve a series of tests and questionnaires that focus on physical symptoms of TBI including neck mobility and pain levels.<br>Other: Sleep Evaluation<br>* These evaluations will focus on assessing insomnia (duration, frequency, daytime consequences), combat exposure, and the presence and severity of trauma history.<br>Other: HDFT MRI<br>* This MRI aims at providing qualitative and quantitative assessments of the nature, location, and extent of white matter injury.<br>Other: MR Spectroscopy (MRS)<br>* This is a noninvasive diagnostic test for measuring biochemical changes in the brain.<br>Other: MEG (Magnetoencephalography)<br>* This is a non-invasive neurophysiological technique that measures the magnetic fields generated by neuronal activity of the brain.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Satisfaction with Life Scale |  | Up to 6 months |