People recovering from a stroke will soon have access to a device that can help restore a disabled hand.
The Food and Drug Administration has approved the so-called device IpsiHand, which uses signals from the uninjured side of the patient’s brain to help reverse the circuits that control the hand, wrist, and hand.
The device can be used at home, and offers stroke patients “an additional treatment option that will help them move their arms and hands again,” said Dr. Christopher Loftus of the FDA Center for Devices and Radiological Health.
IpsiHand’s authority comes after the FDA reviewed results on patients like Mark Forrest, who had a stroke in 2015.
“We called 911 and went to the hospital I went to,” Forrest, who lives near St. Louis. Louis and his wife Patti. “When I got there, most of my right side was paralyzed.”
After six months of rehab, Forrest was walking again, but still had little control over his right arm. He struggled to put on socks and shirts on the buttons.
Still, he missed bass fishing the most in the rivers and lakes near St. Louis.
“I’m a keen fisherman,” he says, “so it really hurt.”
Forrest tried to cut off the fishing rod so he could hold it with his left hand. But his right hand didn’t want to wind in line.
So he continued to work with the physiotherapist, month after month, until he became really frustrated.
“I said, how much more am I going to improve,” Forrest recalls. ‘And she says,’ I don’t think you’re going to improve at all. ‘ That was hard for me to bear. “
That’s when Forrest started talking to people from a company called NeuroLutions. He founded it Dr. Eric Leuthardt, a brain surgeon at the University of Washington School of Medicine in St. Louis. Louis.
For many years, Leuthardt was confused by something he often heard from patients who lost the use of their hands after a stroke.
“If you talk to a patient with a stroke, they can imagine moving their hand,” he says. “I can try to move my hand. But I can’t really move it.”
So Leuthardt sought the source of those thoughts. And he found them in a surprising place: the side of the brain that wasn’t injured by a stroke.
The brain and body usually follow what is known as the contralateral model, where the right side of the brain controls the left side of the body. But Leuthardt’s team found that control signals are also present on the ipsilateral side – the same side of the brain as the limb with which it is controlled.
Leuthardt’s team built a system that could detect and decode these ipsilateral signals. They then connected it to a device that would open and close the patient’s disabled arm when they imagined the action.
But the mechanical arm was not Leuthardt’s ultimate goal. He wanted to help his patients regain the ability to move their arms without help. And that meant answering the question:
“If someone can generate a brain signal that is related to their desire to move, and the exoskeleton moves it, so it gets feedback, can we use this device that controls their affected limb to basically stimulate the brain to reconnect?”
Early experiments suggested that the approach worked. A video of a man with a disability showed how he initially tried and failed to grab the marble and put it on the shelf.
“Then after six weeks of training he can pick up that marble and move it to the top of the shelf,” Leuthardt says.
NeuroLutions tested the device on 40 patients for 12 weeks. They all got better, and the results persuaded the FDA to approve the product’s launch.
Now the company is preparing to produce the system, says NeuroLutions CEO Leo Petrossian, a master with a business degree.
“I got specifically involved in helping take something that was great in clinical studies and realizing how we can now bring that out to millions of people in the U.S. living with a disability after a stroke,” Petrossian says.
The IpsiHand system consists of headphones that analyze brain signals, a tablet computer and a robotic exoskeleton worn over the wrist and hand. Unlike many rehabilitation aids, it can be used at home.
It seems to help people who are no longer getting better at traditional rehabilitation.
It is a common assumption that most recovery from a stroke occurs in the first 90 days or so, Petrossian says. “So if it’s the 100th day and a person can’t move a hand very well, that will be his hand for the rest of his life.”
IpsiH and the study showed that this may not be the case.
“If you spend an hour a day doing this exercise of thinking and visualizing the opening and closing of the hand, five days a week for 12 weeks, you retrain the other part of the brain to run that previously disabled supplement,” says Petrossian.
Mark Forrest, a stubborn fisherman, no longer benefited from traditional rehabilitation when he started using IpsiH and, says his wife Patti Forrest.
“But he has made great strides with this,” she says. “Suddenly, he could touch his index finger with his thumb.”
Mark Forrest decided to test his new skill by building a fishing boat. Dealing with tiny screws remained a challenge. And his friends kept joking that the domestic ship would sink.
“It’s not,” he says. “I made it really nice, and it has wheels at the bottom so it rolls in and out of the water.”
Forrest launched the ship for the first time in March. And he discovered that with his right hand he had regained the ability to wind in a fishing line.
“We sat and fished on that boat for five hours,” he says. “And probably all the other actors were fishing.”