Indiana University / Rehabilitation Hospital of Indiana

Irritability and aggression affect approximately 29-71% of individuals with traumatic brain injury (TBI) and may adversely impact social interactions, relationships, and employment. Yet, there have been few rigorously studied treatments and there is no existing outcome measure that directly captures the impact of irritability and aggression. The current literature is inadequate to support Standards for TBI irritability and aggression management. The Brain Research in Aggression and Irritability Network (BRAIN) investigators have a program underway of innovative research that has begun to address this knowledge gap. The proposed work aims to further the evidence for improving clinical management and outcomes by way of two studies: (1) Buspirone for the treatment of chronic post-TBI irritability & aggression: A 91-day single-site, flexible-dose, parallel group, randomized, double-blind, placebo-controlled trial: The rigorous evaluation of the efficacy of Buspirone in reducing TBI irritability and aggression will potentially result in further innovation in managing this common problem. (2) Preliminary development of the Aggression and Irritability Impact Measure: This study will work towards the development of a standardized measure to evaluate the impact of irritability and aggression on various aspects of functioning and participation. Measuring impact is a novel, yet complimentary approach to existing measures that evaluate the expression of irritability and aggression.

In undertaking research on this pervasive problem that is associated with psychosocial function, the project addresses the National Institute on Disability and Rehabilitation Research Long-Range Plan areas of Health & Function and Community Living and Participation. The proposed research studies were developed with in-depth input from the TBI community, with a solid plan for continued input throughout the course of the project in all aspects including research implementation, interpretation, knowledge translation, project planning, and evaluation. The project covers a wide catchment area with the populations needed for the proposed studies, and includes benchmarks to ensure enrollment of traditionally underrepresented groups. BRAIN is a comprehensive model service delivery and research system serving individuals with TBI. The System includes prevention and emergency medical services, intensive and acute care, comprehensive medical rehabilitation, long term follow-up, community reintegration and vocational rehabilitation. The project is based on the solid integration of Indiana University Health, St. Vincent Health and the Rehabilitation Hospital of Indiana with a community serving approximately 71,322 Indiana residents with long term effects of TBI. BRAIN expects to enroll over 70 participants annually to the TBI Model System national database, amply exceeding the criterion of at least 35.

Rehabilitation Hospital of Indiana

4141 Shore Dr.
Indianapolis IN 46254

Project Officer: Leslie Caplan, Ph.D.
Project Number: H133A120035
Flora Hammond, M.D.
Project 329-2106
James F. Malec, Ph.D.
Co-Project 329-3252
Becky Runkel, MHA
Clinical Research 329-2217
Alicia McClendon
Clinical Study 329-2529
Krista Smith
Clinical Study 329-2565
Aimee Lillie
Research 329-2179