The syNAPse (Study of the Neuroprotective Activity of Progesterone in Severe Traumatic Brain Injuries) study will enroll 1,180 patients from 100 medical centers worldwide to see if previously determined benefits of using progesterone to treat TBI are more likely to be seen if treatment is given within eight hours.
“No new treatments for TBI have been discovered in decades,” said Jack Wilberger, MD, Chairman of the Department of Neurosurgery at Allegheny General Hospital and the hospital’s principal investigator for the syNAPse trial. “This trial may yield the first-ever FDA-approved medical treatment for TBI and greatly impact patients’ ability to heal from these devastating injuries.”
Traumatic brain injury is the leading cause of death and disability in children and young adults. According to the Centers for Disease Control, more than 1.5 million Americans suffer TBI each year, 50,000 of whom die. Brain injury may occur whenever there is a blow to the head, whether or not the skull is fractured and can cause severe disability, including coma, paralysis and death; as well as delayed symptoms such as headaches, memory problems, mood changes, sleeping issues and altering of the senses.
Current treatment for TBI involves maintaining blood pressure and oxygenation while controlling intracranial pressure. Treatment that starts within the first hours after injury is crucial to prevent further brain damage.
Previous studies have indicated that progesterone serves as a brain protector, promoting the repair of the brain after TBI by decreasing brain swelling. Progesterone occurs naturally in both men and women, although it is best known as a female hormone responsible for maintaining pregnancies.
A 100-patient pilot study of progesterone treatment for TBI conducted at Emory University revealed not only that progesterone has no serious side effects, but also that patients with severe TBI who were given the hormone were half as likely to die as those who received placebo. In the Emory study, 13 percent of patients who received progesterone died, while 30 percent of patients receiving placebo died. In patients who had moderate brain injuries, those receiving progesterone were less profoundly disabled.
The SyNAPSe trial will further examine the benefits of administering progesterone and determine if additional benefits may be achieved when the drug is administered quickly. Patients enrolled in the SyNAPse trial must receive progesterone infusion within eight hours of their TBI.
“With head trauma, quick intervention has always been key,” Dr. Wilberger said. “This trial will help to define the benefits of early intervention with progesterone and could result in a new standard of care for patients with severe TBI.”
Allegheny General Hospital plans to enroll 10 patients in the SyNAPse trial over the next two years.
The Neuroscience Program at AGH integrates world-renowned experts in the subspecialties of neurology, neurotology, neuroradiology, neuro-critical care, and neurosurgery to offer world class care for patients with the most complex neurological disorders. Recognized as both a Neurosciences Center of Excellence and a Spine Center of Excellence, the program serves as a national and international referral center for treatment of all types of neurological conditions.