NCT02657135

Targeted Evaluation, Action, & Monitoring of Traumatic Brain Injury

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Traumatic Brain Injury (TBI)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-03-24
• Primary completion: 2018-03-23
• Completion: 2018-03-23
• First posted: 2016-01-15
• Last updated: 2018-07-23

Locations

1 site across 1 country: United States