Targeted Evaluation, Action, & Monitoring of Traumatic Brain Injury

NCT02657135 | Completed DMC

• 1 other identifier: W81XWH-14-2-0002
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury (TBI)

Outcome Measures

Primary Outcomes (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.

  Up to 6 months

Secondary Outcomes (1)

• Change in the Satisfaction with Life Scale

  Up to 6 months

Study Arms (1)

History of Traumatic Brain Injury

EXPERIMENTAL

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

Interventions

Cognitive/Neuropsychological Testing BEHAVIORAL

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.

History of Traumatic Brain Injury

Vestibular/Ocular-Motor Testing OTHER

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.

History of Traumatic Brain Injury

Cervical (Neck) Evaluation OTHER

These assessments will involve a series of tests and questionnaires that focus on physical symptoms of TBI including neck mobility and pain levels.

History of Traumatic Brain Injury

Sleep Evaluation OTHER

These evaluations will focus on assessing insomnia (duration, frequency, daytime consequences), combat exposure, and the presence and severity of trauma history.

History of Traumatic Brain Injury

HDFT MRI OTHER

This MRI aims at providing qualitative and quantitative assessments of the nature, location, and extent of white matter injury.

History of Traumatic Brain Injury

MR Spectroscopy (MRS) OTHER

This is a noninvasive diagnostic test for measuring biochemical changes in the brain.

History of Traumatic Brain Injury

MEG (Magnetoencephalography) OTHER

This is a non-invasive neurophysiological technique that measures the magnetic fields generated by neuronal activity of the brain.

History of Traumatic Brain Injury

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years of age
• Fluent in English
• Documented history of TBI or blast exposure since 2001

You may not qualify if:

• Inability to have MRI
• Pregnancy
• History of TIA within last 6 months.
• Presently involved in open litigation

Sponsors & Collaborators

• University of Pittsburgh: lead
• United States Department of Defense: collaborator

Study Sites (1)

University of Pittsburgh Neurotrauma Clinical Trials Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Neuropsychological Tests; Magnetic Resonance Spectroscopy; Magnetoencephalography

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Magnetometry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 16, 2015
• First Posted: January 15, 2016
• Study Start: March 24, 2014
• Primary Completion: March 23, 2018
• Study Completion: March 23, 2018
• Last Updated: July 23, 2018

Record last verified: 2018-07

Locations

US (1)