The University of Pittsburgh says it will play a leading role in an unprecedented international study aimed at better diagnosing and treating traumatic brain injury, a public health issue that remains shrouded in mystery despite decades of clinical trials.
The National Institutes of Health on Tuesday announced the award of $18.8 million over five years to more than 20 U.S. institutions, including an unspecified amount to Pitt.
David Okonkwo, associate professor of neurological surgery and clinical director of the Brain Trauma Research Center at Pitt, said this is the first large-scale study of TBI that includes the coordinated involvement of the most prestigious government funding agencies in the United States, Canada and Europe.
The European Union will contribute about $49 million to the study, which will involve 38 institutes and more than 60 hospitals there. Details about Canada's multimillion-dollar involvement will be announced later.
"It will be the defining study of traumatic brain injury of our generation," said Dr. Okonkwo, who will lead Pitt's efforts.
He and a team from Baylor College of Medicine in Texas will implement and manage the protocol for recruiting and collecting data on at least 3,000 patients at 11 sites, including Pitt, across the country. More than 5,000 patients will be enrolled in Europe.
"There are fundamental questions about the diagnosis and treatment of traumatic brain injury that simply cannot be answered without a very large study," he said.
The study will attempt to bring a new level of consistency to patient assessment and care, while recognizing that a greater diversity of treatments is needed to address the many variations of injury, Dr. Okonkwo said. "We have to get to the point ... where we can sub-classify brain injury with the same precision we can now sub-classify many cancers."
Better use of magnetic resonance imaging and biomarkers will be among the researchers' goals, he said.
About 2 percent of Americans have TBI-related disabilities. While injuries to military personnel and concussions sustained by athletes have generated attention in recent years, many victims' injuries are "undiagnosed, misdiagnosed, inadequately understood and under-treated," according to the University of California, San Francisco, which is managing U.S. participation in the study.
"After three decades of failed clinical trials, a new approach is needed," Geoffrey Manley, chief of neurosurgery at San Francisco General Hospital and the U.S. study's principal investigator, said in a statement.
While she wasn't familiar with the international study, Dottie Ardell, a member of the Mind Matters brain-injury support group in Butler, cited an urgent need for doctors to become more proficient in diagnosing brain injury and in knowing enough about iterations of TBI to offer families a prognosis. Right now, "they don't really know," said Ms. Ardell, whose son, Keith, sustained a long-term brain injury in a 1987 car accident.
A lack of solid research isn't the only impediment to quality care, she added, noting that limited government funding and insurance restrictions can affect the amount of rehabilitation a patient receives. In some cases, she said, victims today receive less care that her son did.
"It should be better, not worse," said Ms. Ardell, who will co-host the third annual Western Pennsylvania Brain Injury Symposium on Saturday at Slippery Rock University. The public may register at tinyurl.com/symposium-for-brain-injury.
Joe Smydo: firstname.lastname@example.org or 412-263-1548.