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," explained Lester Talley.
Health issues lead to Lester's near fatal accident. The husband and father of two suffered a serious traumatic brain injury.
"My brain had started swelling," he said.
"There really is no definitive therapy for the treatment of acute brain injury," explained Daniel Laskowitz, MD, MHS, Professor Medicine (Neurology), Neurobiology, & Anesthesiology, and Director, Neurovascular Laboratories at Duke University Medical Center.
Lester's wife Ashley feared the worst.
"Seemed like my world was coming to an end," she said.
While in a coma, Lester 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 administered through a dedicated IV line 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, decrease brain swelling, and cell death.
The trial is blinded so Lester 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.
Traumatic brain injury (TBI) occurs when an external mechanical force causes brain dysfunction. It usually results from a violent blow or jolt to the head or body. Mild traumatic brain injury can result in torn tissues, bruising, bleeding, and other physical damage to the brain that can result in long-term complications or death. The degree of damage depends on several factors, including the nature of the event and the force of impact. Injury can include several factors: damage to brain cells may be limited to the area below the point of impact on the skull; a blast can cause widespread damage; a severe rotational jolt can cause the tearing of cellular structures; an object penetrating the skull can cause irreparable damage to brain cells, blood vessels, and protective tissues around the brain; or bleeding in or around the brain, swelling, and blood clots can disrupt the oxygen supply to the brain and cause wider damage. (Source: www.mayoclinic.com)
COMPLICATIONS: Severe injuries can increase the risk of a greater number of complications and more severe complications. Moderate to severe traumatic brain injury can result in prolonged or permanent changes in a person's state of consciousness, responsiveness, or awareness. Some people with TBI will have seizures within the first week. Cerebrospinal fluid may build up in the spaces in the brain of some people who have had TBI's, which causes increased pressure in the brain and swelling. Skull fractures or penetrating wounds can tear the layers of protective tissues that surround the brain. This can enable bacteria to enter the brain and cause infections. An infection of the meninges could spread to the rest of the nervous system if not treated. Also, injuries to the base of the skull can damage nerves that emerge directly from the brain. (Source: www.mayoclinic.com)
NEW TECHNOLOGY: Unfortunately, little can be done to reverse the initial damage caused by a traumatic brain injury. Once it occurs, medical treatment focuses on preventing further injury and promoting rehabilitation. There are currently 13 treatments in clinical development for the potential treatment of TBI. Areas of research include progesterone, stem cells, hypothermia, magnesium sulfate 9, calcium iron influx, and progesterone. SyNAPSe (Study of the Neuroprotective Activity of Progesterone in Severe Traumatic Brian Injuries) is a global, Phase 3, multi-center pivotal trial in severe TBI. The study is evaluating the effectiveness of its proprietary BHR-100 progesterone product as a neuroprotective agent for TBI patients. About 1,200 patients with severe, closed-head TBI enrolled in the study at 150 medical centers, including sites in the United States, Europe, Israel, Asia, and Argentina. The treatment is administered as a five-day continuous intravenous infusion. It also has to be administered within eight hours after the injury. (Source: http://www.synapse-trial.com/about-synapse/) Researchers believe the therapeutic agent will provide significant benefits to patients, including efficacious treatment for TBI patients, decreased mortality form brain injury, reduction of direct and indirect health care costs, and reduction of short-term and long-term disability.
Progesterone, also called P4, is a 21-carbon steroid hormone known for its involvement in the female menstrual cycle, pregnancy, and embryogenesis of humans. Discovery of progesterone's neuroprotective properties began with the observation of a gender difference in response to experimentally induced TBI. Researcher Donald Stein and his colleagues noted that female rats recover better than male rats after TBI, which showed them that the hormone might account for the outcomes. (Source: http://www.synapse-trial.com/why-progesterone/)