Traumatic Brain Injury (TBI)
Conditions
Brief summary
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
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.
Interventions
BEHAVIORALCognitive/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.
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.
OTHERCervical (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.
OTHERSleep Evaluation
These evaluations will focus on assessing insomnia (duration, frequency, daytime consequences), combat exposure, and the presence and severity of trauma history.
OTHERHDFT MRI
This MRI aims at providing qualitative and quantitative assessments of the nature, location, and extent of white matter injury.
This is a noninvasive diagnostic test for measuring biochemical changes in the brain.
This is a non-invasive neurophysiological technique that measures the magnetic fields generated by neuronal activity of the brain.
Sponsors
United States Department of Defense
University of Pittsburgh
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Change in the Satisfaction with Life Scale | Up to 6 months |
Countries
United States
Outcome results
None listed