Evaluation of Outcome Measures for Patients Diagnosed with TBI

Clinical Center

Investigators

Abstract

Since receiving CNS IRB Blue approval on October 6, 2009 the efforts of this project have been placed mainly on acquisition and testing of our specific TBI outcome measures. Our initial focus was on improving our staff competencies as they relate to new or novel assessments and evaluating potential outcome measure test instruments for the TBI population. The protocol has allowed for the staff to evaluate both the appropriateness and tolerance of this extensive battery of assessments. To date nine (9) subjects have been consented and completed the protocol. The major activities have included: acquire and test standardized instrumentation and testing of software; developing data acquisition tools; recruitment; evaluation of subject tolerance of assessments; regulatory compliance with both the NIH, CNRM, and USUHS, including IRB correspondence; and hire personnel to support these efforts. To date our cumulative subject accrual consists of five (5) females and five (5) males. Out of the ten (10) subjects enrolled seven (7) are Caucasian and three (3) are African American or Black. We have enrolled seven (7) healthy volunteers or controls and three (3) diagnosed traumatic brain injured subjects. These participants have allowed for our staff members to familiarize themselves with the newer assessments and tools which are TBI specific. The Protocol has been closed to subject enrollment, yet remains open and available for data analysis.