The University of Washington Traumatic Brain Injury Model System (UWTBIMS) is submitting this application in response to NIDRR notice for awards for Disability Rehabilitation Research Projects, Traumatic Brain Injury Model Systems Centers priority (CFDA Number - 84.133A-5).
The UWTBIMS, funded continuously since 1998, is part of the major academic health care system in the Pacific Northwest (Washington, Wyoming Alaska, Montana, Idaho), comprised of Harborview Medical Center (HMC), University of Washington Medical Center, Airlift Northwest, two community hospitals, and a vigorous primary care network. With HMC as the region’s only Level I Trauma Center, these hospitals and programs provide a comprehensive, integrated continuum of medical, surgical and rehabilitation services for persons with acute and chronic TBI.
We have been a major contributor of high-quality data to the TBI Model System National Database and have forged strong relationships with other Model System centers, other institutions, and consumers. The research track record of the investigators in this center is extremely solid and the UWTBIMS is a national leader for research in telemedicine, self-management treatment, and post-traumatic headache (PTH). Dissemination efforts have included a widely linked Web site with downloadable materials (newsletters, lecture series, and educational brochures); a newsletter featuring information for the greater community; a published workbook for persons with TBI, families, and caregivers; and scientific publications and presentations.
In this proposal, we respond to NIDRR’s Long Range Plan and priorities by: providing a multidisciplinary system of rehabilitation within a full continuum of medical care, contributing 45 new subjects per year to the TBIMS national database with followup data for our 774 currently enrolled subjects, conducting a high quality research site specific project on PTH, participating in a collaborative research project with other centers as determined post-award as well as meeting high expectations for successful collaborative research, coordinating with the Knowledge Translation Center to extend dissemination, addressing the needs of underserved populations with TBI, involving persons with TBI in our center operations and research, and participating actively in all Project Directors’ meetings.
Our research proposal is a Phase II trial of sumatriptan, an FDA-approved treatment for migraine, to treat moderate to severe headache after TBI. During the past cycle, we have led efforts to fully characterize the natural history and clinical presentation of headache, the most common and often disabling physical symptom after TBI. There currently is no evidence-based treatment for PTH and most previous headache clinical trials have excluded persons with TBI. Our proposed trial builds on findings from the TBIMS and will provide the tools and knowledge to conduct definitive phase III trials for treatment of PTH, including: obtaining reliable headache diary data and subject compliance with a complex protocol (necessary to adequately treat
headaches) from those who may have cognitive challenges or require caregiver assistance. We plan to test interactive smart phone and web–based diaries utilizing reminders to determine efficacy and acceptance by subjects and caregivers. These methods will allow us to approximate sample size and provide the information necessary to design an adequately powered Phase III study. We are certain that this research offers excellent potential to improve the function and quality of life for individuals with headache after TBI.