DURHAM, N.C. - It can happen in an instant and change lives forever. Close to two million people are affected by traumatic brain injury every year. Worldwide, it's a major cause of death and disability. Now, researchers are hoping something that our body produces naturally can help bring the first ever TBI treatment to those who need it.
"As I was driving, I blacked out behind the wheel and the car went into the back of a parked 18 wheeler," Lester Talley said.
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," Talley said.
"There really is no definitive therapy for the treatment of acute brain injury," said Dr. Daniel Laskowitz, professor of medicine (neurology), neurobiology, and anesthesiology and director, neurovascular laboratories at Duke University Medical Center.
Talley's wife Ashley feared the worst.
"Seemed like my world was coming to an end," she said.
While in a coma, Talley was enrolled in a phase three trial called SyNAPSe. The study 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," Laskowitz said.
The hormone has to be given within eight hours of an injury. It's infused into the brain for five days straight.
"Also, their ultimate endpoint is how they are doing at six months," Laskowitz explained.
Research shows the drug can rebuild the blood-brain barrier and 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 body and a few memory issues.
"He remembered the most important thing, that I'm his wife. That's what I wanted him to remember," Ashley said.
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.
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