The first-ever FDA-approved brain-computer interface aimed at stroke rehabilitation. The IpsiHand system will be available at the end of 2021.
The new device is designed to help stroke patients restore wrist and hand function. It was approved by the US Food and Drug Administration (FDA). Neurolutions’ IpsiHand is the first brain-computer interface (BCI) to receive agency approval.
The IpsiHand device consists of two separate parts – a wireless exoskeleton that sits above the wrist and a small headgear that records brain activity using non-invasive electroencephalography (EEG) electrodes. The system is based on a discovery made by Eric Leuthardt and colleagues at the University of Washington School of Medicine over a decade ago.
It is known that each side of the brain controls movement on the opposite side of the body. If a stroke disrupts the motor function of the right side of the brain, it affects the movement of the person’s left side.
A discovery by Leuthardt and his team back in 2008 showed that body movement signals can be found on the same side of the brain. However, they are useless if the opposite side is damaged. The fact is that she is, in fact, responsible for performing the movement. This specific brain activity is called ipsilateral brain signals.
The idea behind the new BCI device was to find a way to detect such signals and use them to control an electronic hand restraint. In 2017, scientists conducted a study. In it, they showed how patients using the device for 12 weeks in the context of rehabilitation improved some of their motor functions. They managed to retrain the brain to communicate with the hand.
In other words, the device measures brain activity wirelessly and connects to a hand brace via a tablet, allowing stroke patients to regain movement in their paralyzed arm.
The FDA approval to market the IpsiHand device marks the first time this type of brain-computer interface device has been approved for clinical use in the United States. Approval based on data from clinical trials showing significant improvement in motor function when the device was used for 12 weeks approximately five times a week for at least 10 minutes every day.
It is an interesting precedent that the IpsiHand has received FDA approval. This is the first time a brain-computer interface device of this type has been approved for clinical use in the United States. Approval based on clinical trial data. Patients showed improvement in motor function when using IpsiHand for 12 weeks, five times a week, for 10 minutes per treatment.