"As I was driving, I blacked out behind the wheel, and the car went into the back of a parked 18 wheeler," said Lester Talley.
Health issues led to Talley's near-fatal accident. The husband and father of two suffered a serious traumatic brain injury.
"My brain had started swelling," said Talley.
"There really is no definitive therapy for the treatment of acute brain injury," said Dr. Daniel Laskowitz, a professor in neurology at Duke University.
While in a coma, Talley was enrolled in a phase three clinical trial called SyNAPSe, short for the Study of the Neuroprotective Activity of Progesterone in Severe Traumatic Brain Injuries.
The research is testing if progesterone could help treat TBI. It's a natural hormone produced in men and women that's most often associated with pregnancy.
"There is good evidence that it reduces inflammation," said Laskowitz.
The hormone has to be given within eight hours of an injury. It's infused into the brain for five days straight. The hope is that progesterone will reduce mortality from brain injury and improve short- and long-term disability.
"Their ultimate endpoint is how they are doing at six months," said Laskowitz.
Research shows the drug can rebuild the blood-brain barrier, decrease brain swelling and cell death. The trial is blinded so Talley doesn't know if he got the drug or a placebo, but in six months he's come a long way. He still has trouble with the left side of his body and a few memory issues.
More than 150 sites in 21 countries are taking part in the SyNAPse trial. The goal is to enroll more than 1,100 TBI patients. A 2012 review of the first 200 study participants found there were no safety concerns associated with the treatment.
