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 authorized a device called IpsiHand, which uses signals from the unaffected side of the patient’s brain to help rewire the circuits that control the hand, wrist and arm.
The device can be used at home and offers stroke patients “an additional treatment option to help them move their hands and arms again,” Dr. Christopher Loftus of the FDA’s Center for Devices and Radiological Health said in a statement.
The IpsiHand license comes after the FDA reviewed results on patients like Mark Forrest, who had a stroke in 2015.
“We called 911 and left for the hospital,” Forrest, who lives near St. Louis with his wife Patty. “By the time I got there, most of my right side was paralyzed.”
Six months into rehab, Forrest was walking again, but still had little control over his right hand. He struggled in wearing socks and T-shirts.
What he missed most was bass fishing in the rivers and lakes near St. Louis.
“I’m a hardcore hunter, and that really hurts,” he says.
Forrest tried to cut a fishing pole so that he could grab it with his left hand. But his right hand would not swing in the line.
So he kept working with a physical therapist, month after month, until he got really frustrated.
“I said, ‘How much I’ll get better,'” Forrest recalls. “And she says, ‘I don’t think you’ll hardly ever get better.’ It was hard for me to bear.”
For many years, Lyuthart was puzzled by what he often heard from patients who had lost use of the hand after a stroke.
“If you talk to a stroke patient, they can imagine moving their hands,” he says. “They can try to move their hands. But they can’t actually move it.”
So Leuthard was looking for the source of those thoughts. And he found them in a surprising place: the side of the brain that didn’t have a stroke.
Normally the brain and body follow what is known as the corresponding model, where the right side of the brain controls the left side of the body. But Leuthardt’s team discovered that the control signals were also located on the ipsilateral side – the same side of the brain where the limb is controlled.
Leuthardt’s team has built a system that can detect and decode those similar signals. Then they connected it to a device that opened and closed the patient’s disabled hand when he imagined the procedure.
But the mechanical hand was not the ultimate goal of the leutart. He wanted to help his patients regain the ability to move their hands without assistance. This means answering a question:
“If someone can generate a brain signal associated with their desire to move, and the exoskeleton triggers it, so they get the feedback, can we use this device that controls the affected limb to essentially encourage the brain to rewire?”
Early experiments suggested that the approach worked. A video of a disabled man showed his hand trying first and unsuccessfully to catch the marble and put it on the shelf.
“After six weeks of training, he can pick up the marble and move it over the rack,” says Leuthardt.
NeuroLutions tested the device on 40 patients for 12 weeks. They all improved, and the results convinced the US Food and Drug Administration (FDA) to allow the device to be commercialized.
Now the company is preparing to manufacture the system, says NeuroLutions CEO Leo Petrosyan, a brain scientist with a degree.
“I got involved especially to help take something that’s been great in clinical studies and see how we can now deliver this to the more than 1 million people in the United States who are living with a disability after a stroke,” Petrosyan says.
The IpsiHand system consists of a headset that analyzes brain signals, a tablet computer, and a robotic exoskeleton that is worn over the wrist and hand. Unlike many rehabilitation methods, it can be used at home.
It appears to help people who are no longer improving with conventional rehabilitation.
The conventional wisdom, Petrosian says, is that most stroke recovery occurs in the first 90 days or so. “So, if it’s day 100 and a person can’t move their arm well, that’s how their arm will be for the rest of their life.”
The IpsiHand study shows that doesn’t have to be the case.
“If you spend an hour a day doing this thinking exercise and visualizing the opening and closing of the hand, five days a week for 12 weeks, you are retraining a different part of the brain to drive that previously malfunctioning appendix,” Petrosyan says.
Hardcore hunter Mark Forrest no longer benefited from conventional rehab when he started using IpsiHand, says his wife Patti Forrest.
“But with that he was making big strides,” she says. Suddenly he was able to touch his index finger to his thumb.
Mark Forrest decided to test his new skill by building a fishing boat. Dealing with the small screws was a challenge. His friends kept joking that the homemade boat would sink.
“It didn’t happen,” he says. “I made a really nice one and it has wheels on the bottom of it, so it rolls in and out of the water.”
Forrest launched the boat for the first time in March. He discovered that he had regained the ability to fish on a fishing line with his right hand.
“We sat and fished for five hours on that boat,” he says. “And maybe all the other actors, we were fishing.”