New device for stroke rehab receives FDA approval

May 3, 2021
New device for stroke rehab receives FDA approval

In a stroke, damage to motor function on one side of the brain affects movement on the opposite side of a person’s body. Just this year, a novel device designed to help stroke patients recover wrist and hand function by overcoming this specific problem has been approved by the US Food and Drug Administration (FDA) – the IpsiHand system, the first brain-computer interface (BCI) device to ever receive FDA market approval.

The system is based on a discovery made by Eric Leuthardt and colleagues at the Washington University School of Medicine back in 2008: even if signals for body movement can be detected on the same side of the brain, these signals are still futile when the opposite side of the brain, which is actually responsible for executing the movement, is damaged. This specific brain activity was called ipsilateral brain signals.

The idea behind the IpsiHand BCI device was to find a way to detect those ipsilateral signals and use them to control an electronic hand brace. It was later demonstrated how patients using an experimental BCI device for 12 weeks, in the context of rehabilitation, significantly improved some degree of motor function by essentially retraining their brain to communicate with their hand.

“Generally, any motor impairments experienced by a patient six months after a stroke have been considered permanent,” said Leuthardt. “What we’ve found with this device is that many patients can get a meaningful improvement in recovery of upper extremity movement when we wouldn’t expect them to get any. That’s not really true for any of the current therapies for stroke aimed at restoring function after the initial recovery period.”

The IpsiHand device consists of two separate parts – a wireless exoskeleton that is positioned over the wrist, and a small headpiece that records brain activity using non-invasive electroencephalography (EEG) electrodes. The device wirelessly measure brain activity and, via a tablet, communicates with a hand brace allowing stroke patients to regain movement in a paralysed hand.

Although the IpsiHand is currently not available to patients, commercialisation and eventual clinical access should follow in late 2021, thanks to the FDA’s market authorisation. The approval was primarily based on clinical trial data showing significant motor function improvements when the device was used for 12 weeks, for around five times per week for at least 10 minutes each day.

“It is exciting to say that this is the first FDA-approved brain-computer interface for rehabilitation,” Leuthardt added. “People have been trying for a long time to convert BCI from an experimental technology into something that will truly help patients. With this, we’ve shown that BCI is finally ready for prime time. I sincerely hope there are many more such devices to follow.”

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Category: Features, Technology & Devices

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