A team of experts at San Antonio Military Medical Center has launched a military study aimed at improving outcomes for service members suffering from a signature wound of today's wars: traumatic brain injury.
The Study of Cognitive Rehabilitation Effectiveness, dubbed the SCORE trial, is examining cognitive rehabilitation therapy's value as a treatment for service members with mild TBI.
The Defense and Veterans Affairs departments teamed up on this study to determine the best treatment for combat troops who are experiencing mild TBI symptoms -- such as difficulties with attention, concentration, memory and judgment -- three to 24 months post-injury, explained Douglas B. Cooper, the study's lead and a clinical neuropsychologist for the center's Traumatic Brain Injury Service.
“We have a lot of great interventions to help … in the first few days after concussion,” he said in an interview with American Forces Press Service. “We can pull them out, get them rest and get them better.”
However, “We don't have as many good interventions later on — six months, 12 months or two years post-injury,” acknowledged Cooper, who also serves as the director of the Military Brain Injury Rehabilitation Research Consortium.
The trial's aim is to determine if cognitive rehabilitation therapy improves chronic mild TBI symptoms and, if so, which interventions work best, on whom and why.
Cognitive rehabilitation, Cooper explained, involves a variety of interventions that help patients with brain injuries reduce, manage or cope with cognitive deficits. It's commonly used to treat patients with brain injuries, whether from concussions, penetrating brain injuries or strokes.
With vast experience in the field, Cooper said, he and his colleagues knew anecdotally that the therapy works, meaning it helps to improve memory and focus in patients. However, he added, experts have cited a lack of evidence-based research tying cognitive rehabilitation to successful treatment of brain injuries.
With a lack of in-hand research, insurance companies began to balk on covering it as a stand-alone treatment. For example, TRICARE, the military's health care plan, won't cover cognitive rehabilitation programs that haven't been proven as effective stand-alone therapy for TBI, according to a TRICARE fact sheet.
Rather than step away from the therapy, Congress directed a series of studies to explore cognitive rehabilitation and its effectiveness among troops, Cooper said.
The Defense and Veterans Brain Injury Center took on the challenge and soon enlisted the help of DOD and VA experts. They took a year to write manuals to serve as a trial guide and began enrolling patients in SCORE in July.
They had only a few enrollment criteria: troops must have suffered a mild TBI while deployed in support of operations Enduring Freedom, Iraqi Freedom or New Dawn, and be three to 24 months post-injury, Cooper said.
They had no shortage of available participants. A TBI database shows that more than 202,000 service members suffered a TBI between 2000 and 2010, with the majority experiencing a mild TBI or concussion, according to the Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury. The center cited blasts, fragments, bullets, motor vehicle accidents and falls as the leading TBI causes within the military.
The team plans to treat 160 participants in six-week cycles over the course of two to three years, Cooper said. While in the trial, patients participate two times a day, five days a week, and are entered into one of four treatment paths, or “arms,” he explained.
These treatment paths involve a variety of interventions, and may include individual appointments, group sessions, computer treatments and behavioral health – or a combination of several intervention types.
For the computer exercises, Cooper explained, service members complete a series of commercially available computer programs touted to improve “brain fitness.” These sessions take place in hospital and are proctored by clinic staff.
The programs are presented in a game-like format, he added. As they progress, troops earn “brain bucks” that can be used to outfit a virtual apartment with big-screen televisions and stereos. This suits technology-savvy service members, he noted, who often fall into the under-25 age range.
The team also is looking at the effectiveness of various treatment combinations, such as mental health care and cognitive rehabilitation offered together. More than 50 percent of TBI patients have a coexisting psychological disorder, oftentimes combat stress, Cooper explained, so wrapping the two treatments together makes sense.
An exercise typical of this approach is to have service members listen to a tape and be asked to focus on certain things in their environment, he said. This exercise is first introduced as a cognitive rehabilitation skill, but troops later see its benefits as a tool to overcome combat-related stress.
This integrated treatment is particularly useful for service members who aren't willing to seek behavioral health care on their own, Cooper noted.
“There's still a large stigma attached to mental health care,” he explained. “They may not want to seek behavioral health to get care, but are willing to talk to a psychologist while here getting care for a concussion.”
Cooper said his team will look at each treatment arm to see which interventions have proven most successful and for whom. In general, they're looking for improvements in several areas: working memory, which is holding on to information; prospective memory, which involves remembering to perform a planned action or intention at the appropriate time; and simple attention, which is being able to process what someone is saying at the moment and then remembering what was said.
“We hope to not only look at what interventions work, but then look at subsets of patients -- these particular people haven't shown as much improvement or people with multiple concussions may be harder to treat and so on,” he explained.
As Cooper's team works to improve attention and focus, a parallel study at the medical center here is delving deeper into their patients' brains. Participants of the SCORE trial also are invited to participate in the Imaging Support for Study of Cognitive Rehabilitation Effectiveness, known as the iSCORE study. For this study, experts use cutting-edge imaging technology to scan patients' brains at certain intervals: before the SCORE trial, halfway through, after the trial and at 12 to 18 weeks later.
Imaging experts are hoping to learn more about people's white matter track pathways in the brain, Cooper explained. “Is there something about these that will tell us why individuals are changing?” he asked. “Why are they getting better, and which ones are not able to get better?”
The best clinical trials, he added, raise more questions than they answer.
If the SCORE trial proves successful – meaning it proves cognitive rehabilitation's efficacy – the goal is to determine which interventions are the most effective and then disseminate that information to VA and DOD centers, Cooper said. Civilian providers also may glean ideas that can aid them in the treatment of noncombat-related brain injuries, such as those from a car accident or a stroke.
Meanwhile, Cooper is hoping the study will have a direct, positive impact on troops' well-being and their ability to return to active duty, and, on a bigger-picture level, the health care system as a whole.
Above all, he added, “we want to make sure they're functioning and doing OK.”
The nation has an obligation to ensure service members get the best care and treatment possible, Cooper said.
“They need to feel taken care of, that their complaints are valid, and that they're not alone in going through this process,” he added.
The SCORE trial, he said, “is accomplishing that and more.”