Eight-hundred thousand Americans suffer stroke every year. It is the fifth leading cause of death and is the leading cause of serious disability. Now, researchers at Washington University School of Medicine in St. Louis are testing an innovative system that retrains the uninjured side of the brain, helping stroke patients regain their mobility.
Sixty-four year old Richard Arnold is a retired Missouri paramedic. Five years ago, he suffered a sudden stroke.
Richard told Ivanhoe, "I went and started leaning my head to one side. I don't remember that. But I do remember not feeling well, and things were getting bad quickly."
Kim Arnold, Richard's wife said, "They told me that he would never walk or talk."
Richard proved the doctors wrong, but his right side was weak and his hand remained paralyzed.
Eric Leuthardt, MD, Associate Professor of Neurological Surgery at Washington University in St. Louis School of Medicine is an expert in the field of brain computer interface. They are devices that let the brain communicate with computers; restoring signals that have been cut due to stroke or injury.
Dr. Leuthardt told Ivanhoe, "Basically, if they've been injured on the right, we're taking signals from the left."
Dr. Leuthardt and his colleagues are testing a stroke glove called an IPSI Hand. Patients wear a cap with sensors, connected to a computer. Then they think about moving their fingers.
"With continued usage, their brain is relearning how to control that hand," Dr. Leuthardt explained.
Richard does the therapy seven days a week. The Arnolds' say it's making a huge difference.
Kim said, "He would have to lie down and get his pants on, and sometimes in the beginning it would take 20 minutes. Now it's something that he just does like every day people do."
Richard told Ivanhoe, "The best thing that I wanted to be able to do is hold my wife's hand."
"The strength's coming back, and he's my Superman," exclaimed Kim.
Dr. Leuthardt has started a spinoff company, Neurolutions, to manufacture the equipment. To avoid a conflict of interest, another Washington University researcher is leading the testing phase of the clinical trial which is expected to be completed within the next six months. They are working with the FDA at this time.
Contributors to this news report include: Cyndy McGrath, Supervising Producer/Field Producer; Cortni Spearman, Assistant Producer; Kirk Manson, Videographer and Jamison Koczan, Editor.
BACKGROUND ON STROKE: Despite being one of the leading causes of death in the U.S., there are nearly seven-million stroke survivors. A stroke can happen to anyone at any time, but your risk does increase with age. Up to 80-percent of strokes are preventable. Women experience more strokes than men each year simply because women live longer. Stroke kills twice as many women than breast cancer does each year. About one-fourth of the nearly 800-thousand strokes that occur each year are recurrent events. There are two types of strokes, hemorrhagic and ischemic. Hemorrhagic stroke occurs when either a brain aneurysm bursts or a weakened blood vessel leaks. Hemorrhagic strokes are responsible for about 40-percent of all stroke deaths. Ischemic stroke occurs when a blood vessel carrying blood to the brain is blocked by a blood clot. Ischemic strokes account for about 87-percent of all strokes. Teenagers, children, newborns, and even unborn babies are capable of experiencing a stroke. The risk of stroke in children is greatest in the first year of life and during the period right before or right after birth. Currently, stroke is one of the top 10 causes of death in children.
(Source: http://www.stroke.org/understand-stroke/what-stroke/stroke-facts)
MORE FROM DR. LEUTHARDT: According to Eric C. Leuthardt, MD, Director of the Center for Innovation in Neuroscience and Technology at the Washington University in St. Louis, there are 400,000-500,000 stroke patients a year and this number is only growing because we have an aging population. He says that one of the most common difficulties faced with patients who have had a stroke is loss of hand functions. While there are clot-busting drugs that can help restore blood flow, and physical therapy, about 40-percent of the patients are left with a permanent deficit in their hand after a stroke.
NEW TECHNOLOGY: Researchers at the Washington University School of Medicine in St. Louis are testing a new system that will retrain the uninjured side of the brain caused by a stroke. If the stroke occurred on the right side of a patients' brain, the left side of the body is affected. The device takes signals from the brain of the side that is not affected and decodes the intentions. Dr. Leuthardt says the device is a wearable robotic exoskeleton that opens and closes the hand when the patient has the intention to move it. The device is in the process of being cleared by the FDA but should be available to patients in the next few years.
(Source: Dr. Eric C. Leuthardt, MD)
FOR MORE INFORMATION ON THIS REPORT, PLEASE CONTACT:
Dana Glass
Washington University in St. Louis
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Eric C. Leuthardt, M.D., Associate Professor of Neurosurgery, Biomedical and Mechanical Engineering, and Director of the Center for Innovation in Neuroscience and Technology, discusses a new device helping rewire the brain during a stroke.
Interview conducted by Ivanhoe Broadcast News in September 2014.
When a patient suffers a stroke what are some of the biggest challenges physically that they have to get over?
Dr. Leuthardt: When a person has a stroke it usually means they've had bleeding within their brain. Often, stroke patients will experience loss of hand function - their hand becomes paralyzed and balled up in a fist.
What are the common treatments?
Dr. Leuthardt: Within three hours of the onset of a stroke, a person can receive tissue plasminogen activator or TPA, which is a clot buster that can restore blood flow to the brain preventing brain cells from dying. And then the first six months after the stroke, physical therapy and rehabilitation can help restore some hand function.
I know it probably depends upon individual cases but how successful are most patients with that therapy?
Dr. Leuthardt: About 40 percent of stroke patients are left with permanent motor function deficits in the hand.
What have you developed that can help?
Dr. Leuthardt: For the past eight years, we've been working to understand how the brain processes movement. One side of the brain is thought to control the opposite side of the body. So if someone has a stroke that affects the right side of the brain, the left side of the body is affected. We wondered how much the same side of the brain works to operate the same side of the body. Several years ago, we discovered brain signals associated with same side limb movements. We found that the same side of the brain is involved with moving the same side limbs, but more likely with planning than actual movement. And so that allowed us to tap into those motor intentions with what we call brain computer interface or BCI. BCI is a device that decodes some of the intentions of the brain and then uses those intentions to control a machine. In this case we asked stroke patients to wear a cap on their head, which picked up singles from their uninjured hemisphere -- signals associated with that intention to move the hand that they can no longer move. That intention from the uninjured hemisphere then controlled a wearable robotic prosthetic that opens and closes the patient's hand. By continually practicing this movement with the prosthetic, the brain is getting feedback and inducing a type of plasticity. This practice allows the brain to make new connections to have the uninjured hemisphere control the paralyzed hand.
So you're talking about the brain basically being able to rewire itself? Tell me a little bit about that?
Dr. Leuthardt: There's a classic scientific name for this it's called ‘heavy in learning'. Another way to say this is – ‘things that fire together wire together'. That means if a brain activation is coupled with some type of input or stimulation, then it's training the brain to rewire different areas together. When the brain picks up on those intentions to move the hand, and associates the intentions with actual movement of the hand, that sensory input -- that sensation of moving the hand -- is coupling to that new brain activation that we're detecting in the uninjured hemisphere.
What is the lag time?
Dr. Leuthardt: Maybe a millisecond.
And you had mentioned it's hooked to a prosthetic. Is the thought then you could just take a step so you could get rid of prosthetic?
Dr. Leuthardt: Absolutely, yes. Some of our first patients are making substantial improvements in their hand function without the prosthetic. Their brain is relearning how to control that hand. Our very first patient presented with a balled fist -- basically a nonfunctional limb. And after working with the cap and prosthetic for several months, he can now button buttons, he can hold his wife's hand, he can put his pants on, he can turn on light switches, - all little things, but all have substantially improved his quality of life. One of the most dramatic moments for me was when he said: ‘Dr. Leuthardt, I can put my pants on by myself'. This process gave him back some dignity.
Is this project still investigational? Has the trial stopped?
Dr. Leuthardt: This is a clinical trial and I was a key inventor. My lab developed the technology. Now there is a separate trial led by Dr. Thy Huskey at the Rehabilitation Institute of St. Louis. Dr. Huskey is leading the clinical trial to formally evaluate clinical benefits on all participants.
What is the potential for this technology? You're starting with stroke where do you go next?
Dr. Leuthardt: I think brain computer interfaces have enormous potential for stroke patients with and all types of motor disabilities. If we can impact patients with a paralyzed hand we're helping 400,000 to 500,000 patients per year. That's a big number! And since we have an aging population, people still smoke, and we're in the midst of an obesity epidemic stroke numbers will continue to grow. But we also think this technology may have a role to play in people with spinal cord injuries and people with amputations.
I want to make sure that I'm clear – with the brain computer interface, what part does the computer play?
Dr. Leuthardt: The computer decodes the brain signals and identifies the brain's intentions. Specifically, in this initial clinical trial, the intention – the thought - is to move the paralyzed hand. So the brain computer interface is decoding your thoughts.
How many people are enrolled now?
Dr. Leuthardt: Right now we've enrolled approximately 13 patients. The targeted enrollment is 20 to 25. We're hoping to finish this initial trial in the next several months.
I know the FDA has to give certain approval for drugs. Is it the same thing?
Dr. Leuthardt: Yes, that's right.
Can you tell me what that process is?
Dr. Leuthardt: Well, unfortunately I am not an expert in the process but I know it is a very detailed, meticulous process. Big picture - we will submit a letter to the FDA basically asking for clearance of this device. Fortunately, since this device is not invasive - meaning it doesn't require surgery and it's easy to put on - it's very low risk. Hopefully that will make it relatively straight-forward to get an FDA approval.
What's the time frame, or is it on a time frame?
Dr. Leuthardt: It's in process right now but hopefully we'll know within six months to a year.
Is there anything I didn't ask you that you want to make sure that people know about this?
Dr. Leuthardt: Just that the trial is now open for people who have suffered a stroke more than six months ago, and have an affected hand. The NeuroLutions website (http://neurolutions.com/) has information on how to contact us and potentially join the trial.
What's the name of more time?
Dr. Leuthardt: The company is called NeuroLutions.
Is that a spinoff company from Washington University?
Dr. Leuthardt: From Washington University and me.
You said about six months to a year hopefully?
Dr. Leuthardt: Hopefully, six months for FDA approval, we're projecting that hopefully by 2016 this device/protocol can be available for patients everywhere.
I would imagine there's a varied level of success depending on the extent of the damage?
Dr. Leuthardt: That is something we're investigating. The nice think about our approach is that we're using unaffected hemispheres. So no matter how damaged one side of the brain is, we're relying on the part that's undamaged.
Is there anyone for whom this would not be a good fit?
Dr. Leuthardt: There are certain exclusion criteria. For example, people who have damage to the part of the brain that affects how they understand instructions wouldn't be able to put on the device. And people whose attention capacity is diminished wouldn't be able to concentrate on moving a limb would also not be candidates for this approach.
Who are the ideal candidates?
Dr. Leuthardt: The ideal candidates are patients who've had a stroke, they're greater than six months out and they have a paralyzed upper extremity or arm.
The patients that you've seen, is it more men than women?
Dr. Leuthardt: It's an equal number.
Is it across the board?
Dr. Leuthardt: Yes, it's equal numbers from both a gender and ethnic standpoint.
How about age range?
Dr. Leuthardt: Generally people 50-years-old and older. But we're certainly not excluding younger people by any stretch!
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