Targeted Evaluation, Action, & Monitoring of Traumatic Brain Injury (TEAM-TBI)
Primary Purpose
Traumatic Brain Injury (TBI)
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive/Neuropsychological Testing
Vestibular/Ocular-Motor Testing
Cervical (Neck) Evaluation
Sleep Evaluation
HDFT MRI
MR Spectroscopy (MRS)
MEG (Magnetoencephalography)
Sponsored by
About this trial
This is an interventional health services research trial for Traumatic Brain Injury (TBI)
Eligibility 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
Sites / Locations
- University of Pittsburgh Neurotrauma Clinical Trials Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
History of Traumatic Brain Injury
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in the Satisfaction with Life Scale
Full Information
NCT ID
NCT02657135
First Posted
July 16, 2015
Last Updated
July 19, 2018
Sponsor
University of Pittsburgh
Collaborators
United States Department of Defense
1. Study Identification
Unique Protocol Identification Number
NCT02657135
Brief Title
Targeted Evaluation, Action, & Monitoring of Traumatic Brain Injury
Acronym
TEAM-TBI
Official Title
Targeted Evaluation, Action, & Monitoring of Traumatic Brain Injury
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
March 24, 2014 (Actual)
Primary Completion Date
March 23, 2018 (Actual)
Study Completion Date
March 23, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
United States Department of Defense
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury (TBI)
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
95 (Actual)
8. Arms, Groups, and Interventions
Arm Title
History of Traumatic Brain Injury
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive/Neuropsychological Testing
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Vestibular/Ocular-Motor Testing
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Cervical (Neck) Evaluation
Intervention Description
These assessments will involve a series of tests and questionnaires that focus on physical symptoms of TBI including neck mobility and pain levels.
Intervention Type
Other
Intervention Name(s)
Sleep Evaluation
Intervention Description
These evaluations will focus on assessing insomnia (duration, frequency, daytime consequences), combat exposure, and the presence and severity of trauma history.
Intervention Type
Other
Intervention Name(s)
HDFT MRI
Intervention Description
This MRI aims at providing qualitative and quantitative assessments of the nature, location, and extent of white matter injury.
Intervention Type
Other
Intervention Name(s)
MR Spectroscopy (MRS)
Intervention Description
This is a noninvasive diagnostic test for measuring biochemical changes in the brain.
Intervention Type
Other
Intervention Name(s)
MEG (Magnetoencephalography)
Intervention Description
This is a non-invasive neurophysiological technique that measures the magnetic fields generated by neuronal activity of the brain.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Change in the Satisfaction with Life Scale
Time Frame
Up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of Pittsburgh Neurotrauma Clinical Trials Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Targeted Evaluation, Action, & Monitoring of Traumatic Brain Injury
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