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

University of Pittsburgh

Status: Completed

Conditions: Traumatic Brain Injury (TBI)

Treatments: Behavioral: Cognitive/Neuropsychological Testing; Other: HDFT MRI; Other: MR Spectroscopy (MRS); Other: Vestibular/Ocular-Motor Testing; Other: MEG (Magnetoencephalography); Other: Sleep Evaluation; Other: Cervical (Neck) Evaluation

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02657135

W81XWH-14-2-0002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 95 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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95 participants in 1 patient group

History of Traumatic Brain Injury

Experimental group

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.

Treatment:

Other: MR Spectroscopy (MRS)

Other: Vestibular/Ocular-Motor Testing

Other: MEG (Magnetoencephalography)

Behavioral: Cognitive/Neuropsychological Testing

Other: Sleep Evaluation

Other: Cervical (Neck) Evaluation

Other: HDFT MRI