An interventional study of Cognitive/Neuropsychological Testing and Vestibular/Ocular-Motor Testing in Traumatic Brain Injury (TBI), sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-07-23.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Health services research
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.
2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.
This study's enrollment of 95 is above the median of 48 across 1,331 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · Other: Vestibular/Ocular-Motor Testing · Other: Cervical (Neck) Evaluation · Other: Sleep Evaluation · Other: HDFT MRI · Other: MR Spectroscopy (MRS) · Other: MEG (Magnetoencephalography)
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.
These assessments will involve a series of tests and questionnaires that focus on physical symptoms of TBI including neck mobility and pain levels.
These evaluations will focus on assessing insomnia (duration, frequency, daytime consequences), combat exposure, and the presence and severity of trauma history.
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.
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.
Time frame: Up to 6 months
Change in the Satisfaction with Life Scale
Time frame: Up to 6 months
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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