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

• ClinicalTrials.gov Identifier: NCT02657135
• Recruitment Status: Completed
• First Posted: January 15, 2016
• Last Update Posted: July 23, 2018
• Sponsor: University of Pittsburgh
• Collaborator: United States Department of Defense
• Information provided by (Responsible Party): David Okonkwo, MD, Phd, University of Pittsburgh

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.

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 95 participants
• Allocation: N/A
• 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

Arms and Interventions

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.

Outcome Measures

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 ]

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

More Information

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

Additional relevant MeSH terms:

Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System