Targeted Evaluation, Action, & Monitoring of Traumatic Brain Injury (TEAM-TBI)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02657135|
Recruitment Status : Completed
First Posted : January 15, 2016
Last Update Posted : July 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Traumatic Brain Injury (TBI)||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)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||95 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Targeted Evaluation, Action, & Monitoring of Traumatic Brain Injury|
|Actual Study Start Date :||March 24, 2014|
|Actual Primary Completion Date :||March 23, 2018|
|Actual Study Completion Date :||March 23, 2018|
Experimental: 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.
Behavioral: 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.
Other: 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.
Other: 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.
Other: Sleep Evaluation
These evaluations will focus on assessing insomnia (duration, frequency, daytime consequences), combat exposure, and the presence and severity of trauma history.
Other: HDFT MRI
This MRI aims at providing qualitative and quantitative assessments of the nature, location, and extent of white matter injury.
Other: MR Spectroscopy (MRS)
This is a noninvasive diagnostic test for measuring biochemical changes in the brain.
Other: MEG (Magnetoencephalography)
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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02657135
|United States, Pennsylvania|
|University of Pittsburgh Neurotrauma Clinical Trials Center|
|Pittsburgh, Pennsylvania, United States, 15213|