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Completed

NCT Number: NCT02657135

Targeted Evaluation, Action, & Monitoring of Traumatic Brain Injury

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.

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Key information

Conditions

Traumatic Brain Injury (TBI) Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh Neurotrauma Clinical Trials Center

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive/Neuropsychological Testing

Behavioral

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.

Vestibular/Ocular-Motor Testing

Other

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.

Cervical (Neck) Evaluation

Other

These assessments will involve a series of tests and questionnaires that focus on physical symptoms of TBI including neck mobility and pain levels.

Sleep Evaluation

Other

These evaluations will focus on assessing insomnia (duration, frequency, daytime consequences), combat exposure, and the presence and severity of trauma history.

HDFT MRI

Other

This MRI aims at providing qualitative and quantitative assessments of the nature, location, and extent of white matter injury.

MR Spectroscopy (MRS)

Other

This is a noninvasive diagnostic test for measuring biochemical changes in the brain.

MEG (Magnetoencephalography)

Other

This is a non-invasive neurophysiological technique that measures the magnetic fields generated by neuronal activity of the brain.

Primary outcomes

  1. 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

Secondary outcomes

  1. Change in the Satisfaction with Life Scale

    Time frame: Up to 6 months

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • United States Department of Defense

Registry information

Acronym: TEAM-TBI

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jan 15, 2016
Registry last updated
Jul 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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