Traumatic Brain Injury: Clinical Trials from the Past to the Future

Traumatic brain injury (TBI) is a major cause of life-long disability, and it strikes hundreds of people every day.  The process by which the brain attempts to repair itself after injury is inherently “messy” and involves many interrelated physiological changes.  To date, around 230 trials have been conducted to test the efficacy of neuroprotective drugs and other treatments, and all but two or three have been complete failures.  In the future, because of the complexity of the brain’s response to injury, physicians should begin to think about using individually tailored and combinatorial therapies. 

A number of clinical trials have suggested that certain therapies do not affect all people equally.  A large study conducted to determine whether hypothermia can be used to limit the severity of TBI, for example, showed that hypothermia did not produce statistically significant improvements across the entire population but that it did help people younger than 45.  The research community has moved quickly from animal models in which there is almost no variation between individuals to human trials in which the patient population is very diverse.  In future human trials, researchers should look at patient subgroups in addition to the study population as a whole.

Combinatorial therapy may also become important in the future.  A variety of treatments, ranging from medication to forms of physical therapy, have been proposed to limit the severity of TBI, and negative interactions between many of these diverse treatments seem unlikely.  Few treatments produce major effects alone, but patient outcomes might improve if multiple therapies are used together.

Non-pharmacological treatments for TBI are also under investigation.  Wearable devices are being designed to deliver cortical, deep brain, vagus nerve, and transcranial magnetic stimulation, respectively.  Neurorestorative therapies involving stem cells have also been tried, and some of these techniques have shown promise.  Virtual reality games, implanted microstimulators, and brain-to-computer interfaces are also being developed to help patients recover lost functional abilities.  If some of these new treatments prove to be successful, hopefully they will be integrated with more traditional therapeutic approaches.

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