Targeted Evaluation, Action, & Monitoring of Traumatic Brain Injury

Not Applicable

Completed

• Conditions: Traumatic Brain Injury (TBI)
• Interventions: 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)

• Registration Number: NCT02657135
• Lead Sponsor: University of Pittsburgh

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.

Study Timeline

• Study Start: 2014-03-24
• Study First Submitted: 2015-07-16
• Study First Submitted QC: 2016-01-14
• Study First Posted: 2016-01-15
• Primary Completion: 2018-03-23
• Study Completion: 2018-03-23
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-19
• Last Update Posted: 2018-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

• 18-60 years of age
• Fluent in English
• Documented history of TBI or blast exposure since 2001

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
History of Traumatic Brain Injury	Vestibular/Ocular-Motor Testing	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.
History of Traumatic Brain Injury	MEG (Magnetoencephalography)	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.
History of Traumatic Brain Injury	Cervical (Neck) Evaluation	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.
History of Traumatic Brain Injury	Cognitive/Neuropsychological Testing	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.
History of Traumatic Brain Injury	Sleep Evaluation	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.
History of Traumatic Brain Injury	HDFT MRI	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.
History of Traumatic Brain Injury	MR Spectroscopy (MRS)	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change in the Satisfaction with Life Scale	Up to 6 months

Trial Locations

Locations (1)

University of Pittsburgh Neurotrauma Clinical Trials Center; 🇺🇸 Pittsburgh, Pennsylvania, United States