Progesterone Treatment for TBIs in Final Trial Before USDA Approval

Car accidents, falls, and even sports-related accidents are some of the causes of 1.7 million traumatic brain injuries (“TBIs”) experienced by Americans every year.

TBIs have caused 52,000 deaths and cost more than $60 billion, according to the U.S. Centers for Disease Control and Prevention.

 And for those with a moderate or severe brain injury, there's little help.

BHR Pharma is currently conducting Phase III trial of a study with support from the American Brain Injury Consortium and the European Brain Injury Consortium which tests the hypothesis that the hormone progesterone can reduce the number of TBI related deaths or severe disability. 

This study that began in 2010 has doctors in 21 countries comparing severely brain-injured patients who receive an intravenous progesterone infusion to those who receive a placebo infusion. The study is designed to test the hypothesis that the hormone progesterone can reduce mortality and disability if administered right after a TBI.  Patients must begin the infusion within four hours of the injury, with outcomes assessed after six months.

The Phase III trial is expected to end this summer after enrolling 1,180 patients.  Results should be available in 2014.

Phase III is the last round of testing a treatment must go through before approval can be requested from the U.S. Food and Drug Administration.  That approval could come as early as the end of 2014, said Neta Nelson, global project director of the study and vice president of project management.

Small amounts of progesterone are found in the brains of both women and men, suggesting that it has neuroprotective as well as reproductive functions.

Experts believe progesterone appears to affect multiple physiologic processes that follow an acute injury.  It reduces the cerebral swelling that leads to brain cells dying off.  Progesterone also may blunt cellular damage from free radicals and promote myelin production in damaged nerve cells.

 

Obama Concerned About Brain Injuries in Football

The Super Bowl is just around the corner and brain injuries in the sport are getting almost as much attention as the teams themselves.  Even President Obama has weighed in on the subject, saying that as a parent, he’s not sure he’d allow a son to play.  “I’m a big football fan, but I have to tell you if I had a son, I’d have to think long and hard before I let him play football.”  Obama said in an interview with the New Republic.  “And I think that those of us who love the sport are going to have to wrestle with the fact that it will probably change gradually to try to reduce some of the violence.  In some cases, that may make it a little bit less exciting, but it will be a whole lot better for the players, and those of us who are fans maybe won’t have to examine our consciences quite as much.”      

The NFL has taken most of the public criticism for head injuries, with former players suffering the consequences of years of hard blows.  However, Obama said his greater concern is for amateur players who aren’t getting paid and may not have as full an appreciation of the risks.

“I tend to be more worried about college players than NFL players in the sense that the NFL players have a union, they’re grown men, they can make some of these decisions on their own, and most of them are well-compensated for the violence they do to their bodies,” Obama said.  “You read some of these stories about college players who undergo some of these same problems with concussions and so forth and then have nothing to fall back on. That’s something that I’d like to see the NCAA think about.”

The NFL has stayed a step ahead of the NCAA, both in enforcing rules designed to limit hits to the head and in treating players who suffer concussions.  But fans of football at every level should be prepared for more political pressure on the sport to dramatically reduce hits to the head.

 

CU Coach Takes Stance On One Too Many Concussions

This week, CU football player Will Harlos suffered a concussion during practice, something not uncommon for this player.  Earlier this year Colorado coach Jon Embree said he would not allow redshirt freshman Harlos to continue playing football for the Buffs, if the defender from Somerset, Texas, suffered another concussion.  A concussion is a type of traumatic brain injury, or TBI, caused by a bump, blow, or jolt to the head that can change the way your brain normally works.

Embree followed through on that promise Tuesday when he informed Harlos and his family that he and CU medical staffers consider it unsafe and unwise for Harlos to continue to play for the team.   Embree said Harlos has the option of remaining at CU on scholarship if he medically retires.

Coach Embree understands the severity of brain injuries and their potential impact on the player’s future. His keen understanding of the subject was gained after coaching in the NFL for 5 years.  The league is being sued by nearly 3,500 plaintiffs who claim that it hid information linking concussions and football related head trauma to long-term brain injuries.  Several former NFL stars who had suffered concussions have even taken their own lives in the last several years.

With his first-hand knowledge, Embree decided to draw a line where he would no longer allow a player with a history of concussions to play for him at CU.

"I don't take that lightly," Embree said in the spring. "We have some guys who if they get one more concussion, they're done.  It's not up for debate.  If they want to play, they've got to go somewhere else.  I'm not having it on my shoulders."

Many players, like Harlos, are aware of the dangers of continuing to play with a history of concussions but love the sport too much to give it up. 

" I love football more than I fear for a concussion," Harlos said in the spring.  "It really overcomes it.  I'm not really worried about it.  I just want to come out here and play ball and show these people what I can do." 

Thankfully, Coach Embree took a stance to promote safety for his team players here at CU.  Hopefully, this will set a trend throughout not only college athletics, but even the NFL. 

Concussions and Youth Soccer

Fitness and training industries are also conscientious about concussions in youth sports.  Check out Jen Lesea-Ames, CEO of Fitwise Training, Inc.'s post about ways to identify Concussions in Youth Soccer!

Nelson Law Offices helps those families of children who are injured in youth sports by the negligence of others. 

New Study Calls for Assessment of Traumatic Brain Injury Victims as Potential Violence Risks

In recent findings published in the online journal, Public Library of Science Medicine, British and Swedish scientists found that head injuries can dramatically increase the chances of someone committing violent crime.

In a group of 22,914 traumatic brain injury (“TBI”) victims examined between 1973 and 2009, almost 9% went on to commit acts of violence after diagnosis, which is three times the rate in the general population.  The British and Swedish scientists who carried out the research defined violent criminals as those convicted of homicide, assault, robbery, arson, sexual offences, or illegal threats or intimidation.

Epilepsy was also investigated, as previous studies had suggested it can also increase the risk of violence, but the study found no significant association between it and violent crime.

For the TBI  group, diagnosis before age 16 was associated with a lower risk of violence, as was sustaining a concussion rather than a more severe brain injury.  And individuals whose brain injuries were focal (where the injury occurs in a specific location rather than a more wisespread area) had a higher risk for violence compared with those having more diffuse brain hemorrhagic injuries or cerebral edema.

Author Dr. Seena Fazel from Oxford University, and colleagues wrote: “For traumatic brain injury, absolute and relative risks more clearly suggest that there are certain groups of patients who would benefit from violence risk assessment.  As current guidelines for the assessment of brain injury make no recommendations in relation to the assessment or investigation of violence risk, our findings suggest that these may need review, at least for some groups of patients with traumatic head injury, particularly if they abuse illegal drugs or alcohol.”

Damage to the brain is more than physical; it has behavioral consequences.  According to this new study, a TBI victim has the potential to put another unsuspecting victim in danger of being injured in a violent crime.  Now when a careless driver causes an accident resulting in a victim's TBI, he has potentially created the ripple effect of injuring yet another victim who sustains a TBI.

Soccer 'Headers' Linked to Brain Injury

The ‘non-contact sport’ of soccer may now be linked to traumatic brain injuries (TBI) for certain players.

A study by the Albert Einstein College of Medicine of Yeshiva University in New York of 38 amateur soccer players found that frequent and repeated ‘heading’ of soccer balls may cause TBI.  The study established a threshold of 1000-1500 headings a year as the point where injury was most likely to occur.

"Heading a soccer ball is not an impact of a magnitude that will lacerate nerve fibres in the brain," said Michael Lipton, M.D., Ph.D., director of radiology research at the Albert Einstein College and lead author of the study.  "But repetitive heading may set off a cascade of responses that can lead to degeneration of brain cells."

Researchers used diffusion tensor imaging (DTI) to study the effects of soccer 'heading' and found that players who met the threshold number of headings have abnormalities similar to those found in TBI patients.  The researchers identified five areas, in the frontal lobe (behind the forehead) and in the temporo-occipital region (the bottom-rear areas) of the brain that were affected by frequent heading.  Those areas are responsible for attention, memory, executive functioning, and higher-order visual functions.

Dr. Lipton and colleagues also gave the same 38 amateur soccer players tests designed to assess their neuropsychological function.  Players with the highest annual heading frequency performed worse on tests of verbal memory and psychomotor speed (activities that require mind-body coordination) relative to the other players.

"These two studies present compelling evidence that brain injury and cognitive impairment can result from heading a soccer ball with high frequency," Dr. Lipton said.  "These are findings that should be taken into consideration in planning future research to develop approaches to protect soccer players."

Heading is currently an essential part of the game and the focus of many training drills.  However, Dr. Lipton hopes his team’s findings will be used to create safe guidelines for play, especially for younger players, in the future.  The American Academy of Pediatrics currently recommends that adults who supervise participants in youth soccer should minimize the use of heading the ball until the potential for permanent cognitive impairment is further studied.

Gabby Giffords' Road to Recovery Is Simply Remarkable

Congresswoman Gabby Giffords is certainly an inspiration for those who suffer from a traumatic brain injury (TBI).  Her remarkable road to recovery was well documented and shown on the recent ABC 20/20 Episode. 

Statistically, only about 10% of those who are shot in the head even survive.  Severe brain injuries, such as from gunshot wounds, can leave the victim with physical disabilities, cognitive problems, and behavioral symptoms. The potential physical symptoms can run from total or partial paralysis to things like vision and speech problems, and general fatigue. Cognitive and behavioral disabilities from a severe brain injury can pose devastating problems for the victim too. There are innumerable cognitive and behavioral issues that a TBI victim may have to deal with, including attention, concentration, learning, and memory issues, as well as depression, irritability, and inappropriate behavior issues. Recovery from such a devastating injury is very slow, and improvements can continue to be seen months up to several years later. Some of the recovery is attributable to rewiring of neurons in the brain, sprouting new connections to attempt to regain their former functions and take over functions of the neurons that were lost.

As shown with Congresswoman Giffords, one of the most important parts of the rehabilitation process is family understanding and support for the TBI victim. Dealing with the effects of TBI is a lifelong issue for the family, as well as the victim.