Disclaimer:The views expressed in this abstract are those of the authors and do not reflect the official policy of the Department of Army/Navy/Air Force, Department of Defense, or U.S. Government.Background:Traumatic brain injuries (TBIs) have affected nearly 380,000 service members since 2000. Comorbid posttraumatic stress disorder (PTSD) may result from and/or exacerbate sequelae of mild TBI (mTBI) and is suspected to affect up to 65% of service members with TBI. Conventional treatments for mTBI/PTSD symptoms have limited efficacy and are associated with undesirable side effects. Repetitive transcranial magnetic stimulation (rTMS) has shown promise in treating PTSD symptoms and been identified as a potential mTBI therapy, but is untested as a therapy for comorbid mTBI/PTSD.Methods:This double-blinded, prospective randomized, sham-controlled study consists of 30 treatment sessions 5 weeks of daily sessions followed by a two week taper of 3 and 2 sessions, respectively. Sessions consist of 3500 pulses administered to the left dorsolateral prefrontal cortex (dlPFC) at 10 Hz and 1500 pulses to the right dlPFC at 1 Hz. Approximately 60-80 participants will be randomized to receive active or sham rTMS. Primary outcome measures are the Posttraumatic Checklist 5 and the Rivermead Post-Concussion Questionnaire.Results:The study is ongoing, and 26 participants have been recruited to date. All patients were formally diagnosed with mTBI and reported moderate to severe PTSD symptoms. Preliminary data show no participants have withdrawn due to intolerability or indicated intolerability, despite the presence of minor discomforts such as headache. The majority of participants have been able to rest quietly or sleep during sessions, indicating high tolerability. Reported pain levels are low, with average ratings of 2.84/10.00 by week 2. One limitation was a high dropout rate.Conclusions:This study aims to provide guidance as to whether rTMS is an efficacious therapy for comorbid mTBI/PTSD. Preliminary data indicates it to be a tolerable and safe therapy. Future research should consider decreasing the demand of the study on patients schedules, and performing a comparison to other mTBI/PTSD treatments to determine what treatment is more efficacious.
Introduction Within the population of military service members and veterans, chronic pain is highly prevalent, often complex, and frequently related to traumatic experiences that are more likely to occur to members of this demographic, such as individuals with traumatic brain injury or limb loss. In September 2017, the National Institutes of Health (NIH), Department of Defense (DOD), and Department of Veterans Affairs (VA) Pain Management Collaboratory (PMC) was formed as a significant and innovative inter-government agency partnership to support a multicomponent research initiative focusing on nonpharmacological approaches for pain management addressing the needs of service members, their dependents, and veterans. Methods A Pain Management Collaboratory Coordinating Center (PMC3) was also established to facilitate collective learning across 11 individually funded pragmatic clinical trials (PCTs) designed to optimize the impact of the PMC as an integrated whole. Although the DOD and VA health care systems are ideal sites for the enactment of PCTs, executing these trials within the local context of DOD military treatment facilities (MTFs) can present unique challenges. The Military Treatment Facility Engagement Committee (MTFEC) was created to support the efforts of the PMC3 in its role as a national resource for development and refinement of innovative tools, best practices, and other resources in the conduct of high impact PCTs. Results The MTFEC is composed of experts from each service who bring experiences in executing clinical pain management trials that can enhance the planning and execution of the PCTs. It provides expertise and leadership in the execution of research studies at within MTFs and within the DOD health care system, with guidance from PMC3 Directors and in collaboration with NIH, DOD, and VA program and scientific officers. Discussion/Conclusion Considering the importance of enacting large-scale, pragmatic studies to implement effective strategies in clinical practice for chronic pain management, the MTFEC has begun to actualize its purpose by identifying potential barriers and challenges to study implementation and exploring how the PMC can support and aid in the execution of PCTs by applying similar approaches to stakeholder and subject matter engagement for their research.
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