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Clinical Trials/NCT02657135
NCT02657135
Completed
Not Applicable

Targeted Evaluation, Action, & Monitoring of Traumatic Brain Injury

University of Pittsburgh1 site in 1 country95 target enrollmentMarch 24, 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Traumatic Brain Injury (TBI)
Sponsor
University of Pittsburgh
Enrollment
95
Locations
1
Primary Endpoint
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.
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 24, 2014
End Date
March 23, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

David Okonkwo, MD, Phd

Professor

University of Pittsburgh

Eligibility 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

Outcomes

Primary Outcomes

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 Outcomes

  • Change in the Satisfaction with Life Scale(Up to 6 months)

Study Sites (1)

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