About 1.5 to 2 million people in the U.S. sustain a traumatic brain injury (TBI) each year, leading to 50,000 deaths and 80,000 new cases of long-term disability. It also is a major cause of death and disability among children and military personnel.
Despite the enormity of the problem, scientists have failed to identify effective medications to improve outcomes following a TBI. In fact, no new medical therapies have been developed for traumatic brain injuries in over 30 years.
The study gives hope of finally identifying an agent for the treatment of traumatic brain injury - and possibly other neurological injuries such as stroke, spinal cord injury and multiple sclerosis.
"This is the first therapy exists that improves the outcome of brain injury patients," says Dr. Wright. Emory's researchers designed a clinical trial to assess the promise of progesterone for treatment of TBI. Their three-year pilot study, called ProTECT (which stands for "Progesterone for Traumatic brain injury-Experimental Clinical Treatment"), enrolled 100 participants.
The phase II study was primarily designed to evaluate whether progesterone can be administered intravenously in a reliable way, and whether the treatment is safe to use in humans with TBI. The researchers also hoped to find preliminary evidence that the treatment might be effective.
Although it is widely considered a "sex steroid," progesterone is also a neurosteroid that exerts protective effects on human tissue. It is naturally present in small but measurable amounts in the brains of males and females. Laboratory studies suggest that progesterone is critical for the normal development of neurons in the brain and exerts protective effects on damaged brain tissue.
The research team is now planning a large, multi-center, phase III clinical trial designed to test the effectiveness of progesterone in 1,000 patients with TBI. They also hope to study
the effects of progesterone treatment in animal models of blast-related brain injury, a major cause of death among combat personnel. Additionally, they plan to implement a study of progesterone to treat pediatric brain injury, which is a leading cause of death and disability in children.
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