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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
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
David Okonkwo, MD, Phd, University of Pittsburgh

Brief 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.

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

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.


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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

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  1. Change in the Satisfaction with Life Scale [ Time Frame: Up to 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, Pennsylvania
University of Pittsburgh Neurotrauma Clinical Trials Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
United States Department of Defense

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Responsible Party: David Okonkwo, MD, Phd, Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02657135     History of Changes
Other Study ID Numbers: W81XWH-14-2-0002
First Posted: January 15, 2016    Key Record Dates
Last Update Posted: July 23, 2018
Last Verified: July 2018

Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System