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 a device called the IpsiHand that uses signals from the uninjured side of a patient’s brain to rewire the circuitry used to control the hand, wrist, and arm.
The device can be used at home and offers stroke patients “an additional treatment option so that they can move their hands and arms again,” said Dr. Christopher Loftus of the FDA’s Center for Devices and Radiological Health in a statement.
IpsiHand’s approval comes after the FDA reviews the results of patients like Mark Forrest, who had a stroke in 2015.
“We called 911 and I went to the hospital,” said Forrest, who lives near St. Louis with his wife, Patti. “When I got there, most of my right side was paralyzed.”
After six months of rehabilitation, Forrest was able to walk again but still had little control over his right hand. He struggled to put on socks and button up shirts.
What he missed most was fishing for perch in the rivers and lakes near St. Louis.
“I’m a die-hard fisherman,” he says, “that really hurt.”
Forrest tried to cut off a fishing rod so he could hold it with his left hand. But his right hand did not want to catch the line.
So he worked with a physical therapist month after month until he was really frustrated.
“I said how much more will I improve,” Forrest recalls. “And she says, ‘I don’t think you will hardly improve.’ It was hard to take for me. “
Then Forrest started talking to people at a company called NeuroLutions. It was created by Dr. Eric Leuthardt, a brain surgeon at Washington University School of Medicine in St. Louis.
For many years Leuthardt had been wondering about something he often heard from patients who had lost their hands after a stroke.
“When you talk to a stroke patient, they can imagine moving their hand,” he says. “You can try to move your hand. But you just can’t really move it.”
So Leuthardt had looked for the source of these thoughts. And he found it in a surprising place: the half of the brain that hadn’t been injured by the stroke.
Normally, the brain and body follow a so-called contralateral model, in which the right hemisphere controls the left side of the body. But Leuthardt’s team had found that control signals were also present on the ipsilateral side – that is, on the same half of the brain as the controlled extremity.
Leuthardt’s team built a system that could recognize and decipher these ipsilateral signals. Then they hooked it up to a device that opened a patient’s handicapped hand for him and closed it when he imagined the action.
But a mechanical hand was not Leuthardt’s ultimate goal. He wanted to help his patients move their hand again without assistance. And that meant answering a question:
“If someone can create a brain signal that is linked to their urge to move and the exoskeleton moves them so that they get feedback, can we use this device that controls their affected limb to essentially encourage the brain to rewire?”
Early experimentation suggested the approach worked. A video of a man with a disabled hand showed how he initially tried to grab a marble and place it on a shelf, but failed.
“Then after six weeks of training he can pick up the marble and slide it on the shelf,” says Leuthardt.
NeuroLutions tested the device on 40 patients for 12 weeks. All got better, and the results convinced the FDA to clear the device for marketing.
Now the company is preparing to manufacture the system, says Leo Petrossian, CEO of NeuroLutions, a brain researcher with a degree in business administration.
“I was specifically committed to helping something that was great in clinical trials and how we can now bring it to the millions of people in the US who have had a stroke and are living with a disability,” said Petrossian .
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 aids, it can be used at home.
And it seems to help people who are no longer doing better with traditional rehabilitation.
Popular belief is that most recovery from stroke occurs in the first 90 days or so, Petrossian says. “So if it’s day 100 and a person can’t move their arm very well, their arm will be like that for the rest of their life.”
The study by IpsiHand has shown that this does not have to 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 are retraining a different part of the brain to control this previously disabled limb” says Petrossian.
Mark Forrest, the die-hard fisherman, didn’t benefit from traditional rehabilitation any more when he started using the IpsiHand, says his wife, Patti Forrest.
“But he’s made great progress with that,” she says. “As if he could suddenly touch his index finger with his thumb.”
Mark Forrest decided to test his new skill by building a fishing boat. Dealing with tiny screws was still a challenge. And his friends kept joking that the homemade boat was going to sink.
“It didn’t,” he says. “I made a really nice one and it has wheels on the bottom so it rolls in and out of the water.”
Forrest first launched the boat in March. And he discovered that he had regained the ability to haul in a fishing line with his right hand.
“We sat and fished on this boat for five hours,” he says. “And probably every other litter, we’ve caught fish.”