Targeted Evaluation, Action, & Monitoring of Traumatic Brain Injury

Traumatic Brain Injury (TBI) Clinical Trial

— TEAM-TBI  

Official title:

Targeted Evaluation, Action, & Monitoring of Traumatic Brain Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02657135
• Other study ID #: W81XWH-14-2-0002
• Status: Completed
• Phase: N/A
• Start date: March 24, 2014
• Est. completion date: March 23, 2018

Study information

• Verified date: July 2018
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: March 23, 2018
• Est. primary completion date: March 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury (TBI)
• Wounds and Injuries

Intervention

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.
• 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.
• Sleep Evaluation
These evaluations will focus on assessing insomnia (duration, frequency, daytime consequences), combat exposure, and the presence and severity of trauma history.
• HDFT MRI
This MRI aims at providing qualitative and quantitative assessments of the nature, location, and extent of white matter injury.
• MR Spectroscopy (MRS)
This is a noninvasive diagnostic test for measuring biochemical changes in the brain.
• MEG (Magnetoencephalography)
This is a non-invasive neurophysiological technique that measures the magnetic fields generated by neuronal activity of the brain.

Locations

Country	Name	City	State
United States	University of Pittsburgh Neurotrauma Clinical Trials Center	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Up to 6 months
Secondary	Change in the Satisfaction with Life Scale		Up to 6 months