WASHINGTON
A study run at five military and veterans' hospitals has identified the first highly-scalable intervention for addressing cognitive deficits that can occur after mild Traumatic Brain Injury (mTBI).
The study results were presented at the 9th Annual Traumatic Brain Injury Conference in Washington DC. The intervention studied was the brain training app BrainHQ, made by Posit Science.
More than 383,000 members of the US military have been diagnosed with a Traumatic Brain Injury (TBI). Of these, more than 82% are classified as mild TBI (mTBI), commonly following concussion or blast exposure. In many cases, servicemembers can experience a full recovery from a mild TBI - but for those that do not, cognitive consequences can persist for years with life-altering results. This risk is notably higher for servicemembers returning from the Iraq and Afghan conflicts than for civilians - and as a result, this injury has been called the signature injury of those conflicts.
Current best practices for treatment of persistent cognitive deficits in people with a history of mTBI focus on in-person, customized cognitive rehabilitation, which can be helpful, but is costly, time-consuming, requires travel for treatment, and relies on the craft and expertise of the healthcare provider.
The Department of Defense (DoD) funded the BRAVE Study to determine whether a plasticity-based, computerized, brain-training intervention could be broadly and remotely applied and could produce significant improvements in persistent cognitive deficits across a diverse mTBI population. No computerized cognitive training has previously been shown effective in a Class 1 study (as defined by the American Academy of Neurology).
BRAVE enrolled 83 participants with a history of mTBI and diagnosed with cognitive impairment. Typically, participants had been deployed to combat areas, and, on average, had their most recent mTBI more than seven years earlier. Their average age was 33, and 81% were male. Before training, they tested, on average, about two standard deviations below normal on the ANAM (a cognitive test used by the military to screen for cognitive impairment).
The participants were randomized into a treatment group (BrainHQ) and an active control group (computer games). Both activities were plausibly expected to have some positive impact due to their demands on cognitive realms, such as attention, memory, and reasoning. Each group self-administered training in their own homes (with telephone supervision from trained coaches) and were asked to train for 1 hour per day, 5 days per week, over twelve weeks. Comprehensive cognitive assessments were performed before training, after training, and after a twelve-week, no-training, follow-up period.
The study was conducted through a nationwide network of five military and veterans' medical centers (NICoE/Walter Reed National Military Medical Center in Bethesda; Schofield Barracks/Tripler Army Medical Center in Honolulu; Baylor/Michael E. DeBakey VA Medical Center in Houston; Yale/VA Connecticut Healthcare System in West Haven; and Harvard/VA Boston Healthcare System in Boston); with Posit Science in San Francisco as the study coordination center.
Researchers found the BrainHQ group showed a statistically and clinically significant improvement on overall cognitive function (compared to the computer games group), and this benefit persisted for at least twelve weeks after training completed. Cognitive function improvements were 3.9 times larger in the BrainHQ group than the control (as measured immediately following training) and grew to 4.9 times larger (when measured again 12 weeks after training ended).
On average, participants in the BrainHQ group improved on the cognitive performance composite measure by 24 percentile ranks - as though they went from the 50th percentile to the 74th percentile.
While results on the primary cognitive measure were significant, analysis of functional and self-report measures did not show significant between group differences. However, on many measures both groups showed improvement, suggesting general benefits of cognitive engagement and study inclusion.
When this study was selected for funding, we were hoping it would help troops impacted by mTBI, said Colonel (Ret.) Dallas Hack, a physician who led most of the DoD's research in battlefield trauma when the study began. These results exceed my fondest expectations. The broad applicability, modest cost, and self-directed nature of the intervention mean it could be scaled very quickly.
These are long-awaited and important results, said Dr. Henry Mahncke, CEO of Posit Science. It provides Class 1 evidence that fills the existing gap for a highly-scalable cognitive intervention in evidence-based clinical programs addressing mTBI. The trial also demonstrated that such an intervention can address cognitive issues across a diverse mTBI population, even in remote locations.
BrainHQ has been used in many military and veterans' facilities for cognitive rehabilitation, under supervision of healthcare professionals. With the release of these results, Posit Science (maker of BrainHQ) has indicated it intends to work with clinicians, payors, and regulators to make this widely available, as quickly as possible.
