At TecTraum we believe in science before sales, and that’s what our trial showcases.
To uncover the overall impression, attitude, and function of TecTraum’s Pro-2-Cool™, we implemented funding for a mass clinical trial to validate the product's ability to treat concussions. Pro-2-Cool™ is the first therapeutic treatment available for concussion treatment, and we strive to ensure total safety and tolerability for all users.
TecTraum has contracted with a leading pediatric facility, Akron Children’s Hospital, to serve as the primary investigative site for the trial. The Ohio based hospital draws in an astounding 800,000 patient visits each year from around the world for their pediatric services. Akron Children’s has also earned Best Children’s Hospital rankings by US News & World Report in 6 of the 10 specialties. With the help of Akron Children’s Hospital our trial seeks to identify the therapeutic benefits of cooling therapy delivered through the Pro-2-Cool™ system by studying up to 500 high school athletes across northeast Ohio.
On average, 1 in 5 high school athletes sustain a sports concussion during the season. To preserve head safety and further the advancement of Pro-2-Cool™, we chose young athletes as our participants. Subjects participating in the trial are high school students and athletes between the ages of 14-19.
In the United States alone, nearly 3.8 million sports related concussions occur yearly according to the CDC. Of that alarming number, 33% are sports related, and an astounding 47% occur during high school football. To put that statistic into perspective, more than 1.1 million students play football in the United States.
Sports help teach kids about accountability, teamwork, leadership, and many other crucial life skills. They help shape a person into successful and productive citizens who care about others and giving back. There are many benefits to sports, and a concussion shouldn't be what holds an athlete back. Athletes who get a concussion are vulnerable as currently, there is no standard care for concussions. That’s where Pro-2-Cool™ steps in. The company was founded when several professional athletes joined forces with innovative engineers to solve the problem of the lack of treatment for concussions. We understand the problem, and some of our athletes have first-hand experience. The trial candidates will receive optimum care, and be a part of a revolutionary time in the medical field.
"This is an essential piece of sports equipment that every athlete should be able to access."
— Sam Williams & Justin Fargas, former Oakland Raiders football players
Sports concussions have been a hot topic in the news for the last decade. However, many people often focus on the injury, and forget about the parents looking after their children. At TecTraum, we know parents play a crucial role in our trial. It’s impossible to do a trial and expect every student to have a concussion. Thus, during our trial both affected and un-affected youth can participate in Pro-2-Cool™ treatment. Either way, we believe injured or not, every parent should be aware of what will happen during the trial, and we provide them with a step-by-step rundown of the process, and even let them test out the product.
"Parents invest in sports camps, equipment, and other products that they feel will give their kid an edge. Pro-2-Cool™ will help with you kids' quality of life in sports."
— Sam Williams
Rest is currently the only way to recover from a concussion. However, what if there’s a way to speed up the healing process? With Pro-2-Cool™ we hope to limit the amount of time injured athletes need to spend on recovery. When people hurt themselves, they put ice on the injury to speed up the healing process. So, why not cool the head after a concussion injury? Pro-2-Cool™ wants to be the key to a speedy recovery. The only current method of resting the brain limits activities such as playing video games, reading, texting, schoolwork, and sports. These are actions many people conduct as part of their livelihood. At TecTraum, we want victims of concussions to not be kept in the dark for so long, and we are anticipating Pro-2-Cool™ to be the solution.
How Pro-2-Cool™ Works
The Pro-2-Cool™ system by TecTraum is designed to provide cooling for the head and neck. The cooling works as a hypothermic therapy (cold therapy) device that can cool the brain. The product mirrors a headband that would be strapped around a person’s head and neck. Once in place, the cooling treatment begins.
A step-by-step explanation of how the trial is conducted.
Participant Data Collection
An optimum scoring system for pain assessment is necessary to determine the efficiency of the product. Participants are given a comfort scale to identify their possible discomfort location and its intensity on a scale of 0-10 while using Pro-2-Cool™.
The student’s blood pressure and pulse are tracked during testing to see how the body reacts to the drop-in temperature. The goal of a Pro-2-Cool™ session is to get the subject's temperature to six degrees Celsius. To make sure this goal is met, a digital sublingual thermometer is used to check the body’s core temperature.
Goals of the Trial
The goal of the trial is to determine if the treatment can help a student, athlete, or accident-inflicted person recover from a concussion. Cooling therapy has been around for hundreds of years and is the standard initial care used to protect the brain in several health emergencies such as cardiac arrest, certain types of heart attacks, and more. Our mission is to add concussions to that list, and our vision is to be the first in the world to develop a safe and effective therapy for the treatment of concussions.
One of our goals is to enroll all student athletes at participating schools. We want to infiltrate the problem where it all begins, on a high school field. To do this, we need all students to enroll in the trial. With overall participation we can follow them for 12 weeks, and treat a possible concussion right away.
At TecTraum, we know what our Pro-2-Cool™ device does, and we are eager to show the world after the initial trial phase. An additional goal of ours is to educate participants of the trial, their parents, and the community on the power of cooling therapy. A concussion isn't just a medical term, it's a discussion the world should be part of, and we are paving the way to begin the conversation.
The cooling device is light-weight, easy to travel with, and designed to be used in many situations. Additional items such as a blood pressure cuff, hoodie, measuring tape, and a digital sublingual thermometer used during the treatment are also portable and are widely used already. It is designed to be easy to use, and efficient for trainers to treat injured players on and off the field.
Reduce Long-Term Effects
By introducing an effective therapy treatment for concussions, we are also hoping for a much lower amount of time that those injured deal with the side effects of brain injuries. Symptoms of post-concussion syndrome include physical, cognitive, and emotional problems. While the average brain injury resolves within six weeks, some people still deal with the symptoms longer than this. At TecTraum, we take pride in our goal of conducting a trial that may help people recover from a concussion, and spend less time dealing with the side-effects.
How the Trial Benefits
the Medical Field
There is no standard care for concussions, and this trial can be the breakthrough the medical field has been waiting for. It's not only a trial, but a preview of what's to come. The trial will show us what works, and possibly what doesn't, and in the end, we'll have a device that can potentially speed up the recovery of active teens and adults who are injured while doing what they love. Concussions aren't a disease you can prevent, and they usually result from sport related injuries. However, just because we can't prevent them, doesn't mean we shouldn't strive to heal them. Our trial has set out to do what no other has achieved, and be the first in the world to develop a safe and effective therapy for the treatment of concussions.