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June 06, 2011

Invisible Battle Wounds

(Contributed by Fawna L Start, BS, CCRC, Manager, Clinical Monitoring & Site Management)

Sometimes called the “Signature Wound” of the war, Traumatic Brain Injury (TBI) caused by explosions has become one of the most common combat wounds suffered. As a matter of fact, 25 – 40 percent of soldiers have “invisible wounds”—the psychological and neurological injuries associated with post traumatic stress disorder (PTSD) or TBI. Although the Department of Defense (DoD) and the Veterans Administration (VA) have dedicated unprecedented attention and resources to address PTSD and TBI, evidence suggests that although these policies and strategies have had a positive impact, work still needs to be done.

 

TBI, also called acquired brain injury, or simply head injury, occurs when a sudden trauma causes damage to the brain. TBI can result when the head suddenly and violently hits an object, or when an object pierces the skull and enters brain tissue. Soldiers sometimes walk away from explosions with no obvious injuries. Concussions caused from blasts can sometimes have a lingering effect that is not always immediately apparent. Victims may have a wide range of symptoms such as but not limited to: difficulty thinking, memory problems, attention deficits, mood swings, frustrations, headaches, or fatigue.

 

Brain injury due to trauma is very common, nonetheless, there is no known pharmacological therapy to improve outcomes. Medications are used to treat symptoms, such as seizures and affective disorders, but are not intended to affect the fundamental problem.

 

When it comes to issues of “invisible wounds” like those caused by TBI and psychological issues such as PTSD, Service Members are affected by various stigmas:

Public stigma: The notion that a veteran would be perceived as weak, treated differently, or blamed for their problem if he or she sought help.

 

Self Stigma: The individual may feel weak, ashamed and embarrassed.

 

Structural Stigma: Many Service Members believe their military careers will suffer if they seek psychological services. Although the level of fear may be out of proportion to the risk, the military has institutional policies and practices that restrict opportunities for service members who reveal that they have a psychological health issue by seeking mental health services.

 

EmpiriStat has an in-depth knowledge and understanding of our war-fighters and the stigmas they and their families face every day. EmpiriStat is comprised of veterans and family members of those who serve, as such have more than a passion to support our troops, but the feeling of responsibility to take care of our EmpiriStat family. We embrace research endeavors that will help break stigmas and give our troops the treatments they need.

 

EmpiriStat in collaboration with the Department of Defense is conducting a tri-service intramural research effort to ascertain if Hyperbaric Oxygen (HBO2) has a role in chronic mild TBI. Sponsored by the U.S. Army Medical Research and Materiel Command recruitment has begun for a Phase II randomized trial designed to describe the magnitude of change between baseline and follow-up outcomes for symptom surveys and a battery of neuropsychological tests administered at time points corresponding before and after 10 weeks over observation in four groups.

 

  • A military population with post-concussion syndrome (mTBI) receiving local standard care
  • A military population with post-concussion syndrome (mTBI) receiving local standard care and sham hyperbaric oxygen sessions
  • A military population with post-concussion syndrome (mTBI) receiving local standard care and hyperbaric oxygen at 1.5 atmospheres sessions
  • A otherwise similar group with PTSD but no history of TBI receiving local standard care Differences and variability of the tests will be used for determining the optimum primary endpoint(s) for future trial, as well as for refinement of sample size and power calculations for these studies. The groups undergoing hyperbaric sessions will be assigned to receive HBO2 or sham using a randomized, double blind design.

 

If HBO2, which is regularly available and relatively safe, improves outcome in brain-injured subjects by treating the underlying pathophysiology of post-concussive syndrome, this would represent a significant advance in treatment of brain injury.

 

Hyperbaric Oxygen is one of the first pharmacologic interventions being tested in this population of individuals with mild TBI and chronic post-concussive symptoms targeted to improve cognition, memory, and functional status. However, much is unknown about how to measure improvement in post-concussive symptoms after an intervention in the targeted active duty population. In preparation for a pivotal efficacy study, the objectives of the pilot study are to characterize two candidate primary outcome tools in our intended study population, the RPQ and the NSI, in order to better estimate the sample size needed to answer the efficacy question.

 

Hyperbaric Oxygen Therapy (HBOT) is an intervention in which a patient breathes 100% oxygen intermittently inside a chamber that is pressurized to higher than sea level pressure.

The increased oxygen dissolves in your blood during HBOT, and circulates throughout your body.

Oxygen-rich blood stimulates your body to release substances called growth factors and stem cells, which promote healing. Your body's tissues need an adequate supply of oxygen to function. When tissue is injured, it requires even more oxygen to survive. HBOT increases the amount of oxygen your blood can carry. An increase in blood oxygen temporarily restores normal levels of blood gases and tissue function to promote healing. Currently the only FDA Approved Indications for Hyperbaric Oxygen are: Decompression Sickness, Air/Gas Embolisms, Crush Injuries, Enhanced Healing of Selected Wounds, Carbon Monoxide Poisoning and Smoke Inhalation, Exceptional Blood Loss, Intracranial Abscess, Radiation Tissue Damage, Gas Gangrene, Skin Grafts and Flaps, Necrotizing Soft Tissue Infection, Thermal Burns, Osteomyelitis.

 

Agency for Healthcare Research and Quality (AHRQ) conducted a comprehensive review of the literature, interviewed subject matter experts (SME), and conducted focus groups with SMEs to evaluate the evidence HBO2 has for patients with TBI. The AHRQ concluded that "Although they are cited frequently, the case series and time-series studies of HBO2 for TBI patients had serious flaws. There were no high-quality studies of the use of HBO2 to improve function and quality of life in patients with chronic, stable disabilities from TBI. The most important gap in the evidence is a lack of a good quality time-series study or controlled trial of the effects of HBO2 on cognition, memory, and functional status in patients with deficits due to mild chronic TBI" (clinicaltrials.gov). Similarly, the Department of Health and Human Services (DHHS) has not approved HBO2 therapy for the treatment of TBI as a covered condition, citing the lack of supporting evidence for clinical efficacy.

 

The Defense Centers of Excellence for Psychological Health and Traumatic concluded that sufficient case reports, early safety and feasibility study data, and basic scientific plausibility exist to warrant prompt experimental study of HBO2 in the care of the full spectrum of chronic TBI. This would best be accomplished in a randomized, double-blind, multi-center clinical trial (clinicaltrials.gov).

 

The purpose of this Phase II study is to describe the magnitude of change between baseline and follow-up outcomes for a battery of neuropsychological tests within groups. A secondary objective is to explore changes across the four groups. Differences and variability of the tests will be used for determining the optimum primary endpoint(s) for the Phase III trial, as well as for refinement of sample size and power calculations for this future study. Recruitment, randomization, blinding, and study and intervention logistics and planning will also be assessed.

 

Subjects included in the study will be: Active duty military (Army, Marine, Navy, Air Force) men and non-pregnant women residing in the United States and who will remain in the military for the entire study period, aged 18-65 years who have been deployed one or more times to the US Central Command since the initiation of Operation Enduring Freedom (October 7, 2001) who either:

 

  • have been diagnosed with Post Traumatic Stress Disorder (PTSD) as a result of traumatic events that occurred during the qualifying CENTCOM deployment, but have no diagnosed or suspected lifetime brain injuries resulting in loss or alteration of consciousness; OR
  • have been diagnosed with at least one mild brain injury (mTBI) with persistent (> 4 months) symptoms sustained during one or more of those deployments

 

Service Members suffering from PTSD and or TBI have had little to look forward to, but with this new research endeavor hope is on the horizon. While traveling I met a woman whose brother returned from a deployment in Iraq having suffered a TBI. Her story touched my heart and brought home the importance of research projects like this one.

 

She quit her job in Florida, left her daughter there with grandparents, and moved to Colorado to care for her brother who now could not care for himself. With little proven treatments for TBI and few options, his injury soon cost him his marriage, his children, and his career. Medically discharged, divorced and turning to alcohol this man’s story does not have a happy ending but through dedication and research other stories can. Personally, as the wife of an Active Duty Service Member and professionally as a researcher, I can only hope that with the continued efforts of organizations like EmpiriStat, stories like this will become a thing of the past.

 

If you are interested in further information about this research project please contact: the Study Coordinating Center at 877-445-3199. For a more detailed description of this and other studies like it you may visit www.clinicaltrials.gov and search HOPPS TBI and click on the study title.

 

EmpiriStat is proud to be a part of this research project and is committed to providing and maintaining the highest scientific rigor and ethical standards-while providing both timely and cost-effective services. This endeavor is also indicative of EmpiriStat’s goals which are to collaborate with partners that share a common goal for the advancement of science in areas of research with high impact to public health. With a unique goal: to discover the truth as far as possible EmpiriStat is well aware of the increasing need for treatments for our soldiers returning with post concussive syndrome and the long term risk it poses to patients; and thus is excited to be part of the team working to solve these problems.



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