Epidemiological Study of Mild Traumatic Brain Injury Sequelae Caused by Blast Exposure During Operations Iraq Freedom and Enduring Freedom
Abstract
We accomplished Institutional Review Board (IRB) full approval of our initial submission, protocol amendment, and subject recruitment advertisements both locally (McGuire VAMC) and at Army Headquarters (USAMRMC). A subsequent request for an additional Walter Reed Army Medical Center IRB approval by our Military partner study site (Kenner Health Clinic, Fort Lee, VA) is currently under review. Three full-time research assistants and a part-time Data Manager have been recruited and trained. Study procedures, recruitment, data management, and analyses have been refined through meetings, reviews, consultations, and mock study form completions. Subject recruitment and protocol implementation commenced at the VAMC site in December 2008. Through July 31, 2009, thirty-two (32) subjects have been accrued through Polytrauma Network Site Clinic screening, and on-site enrollment at Fort Lee, Virginia. While data analysis is premature, most appear to meet symptom criteria for PCS. Enrollment has commenced for this study of blast-related MTBI among OIF/OEF returnees. Early results suggest that recruiting OIF/OEF veterans with blast-related PCS is feasible. The accumulating sample should also be suitable for intervention trials under development. To ensure a sample representative of the target population, we are addressing the regulatory requirements for enrollment at our Military partner site, and mailing outreach recruitment letters to all local veterans with OIF/OEF service.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2009
- Accession Number
- ADA513217
Entities
People
- William C. Walker