Targeted Evaluation, Action, & Monitoring of Traumatic Brain Injury (TEAM-TBI)

July 19, 2018 updated by: David Okonkwo, MD, Phd, University of Pittsburgh
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

95

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Neurotrauma Clinical Trials Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome 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.
Time Frame: Up to 6 months
Up to 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in the Satisfaction with Life Scale
Time Frame: Up to 6 months
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

United States Department of Defense

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 24, 2014

Primary Completion (Actual)

March 23, 2018

Study Completion (Actual)

March 23, 2018

Study Registration Dates

First Submitted

July 16, 2015

First Submitted That Met QC Criteria

January 14, 2016

First Posted (Estimate)

January 15, 2016

Study Record Updates

Last Update Posted (Actual)

July 23, 2018

Last Update Submitted That Met QC Criteria

July 19, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • W81XWH-14-2-0002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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