Deans' stroke musings: FDA OKs Brain-Computer Interface Device for Stroke Rehab

Changing stroke rehab and research worldwide now.Time is Brain! trillions and trillions of neurons that DIE each day because there are NO effective hyperacute therapies besides tPA(only 12% effective). I have 523 posts on hyperacute therapy, enough for researchers to spend decades proving them out. These are my personal ideas and blog on stroke rehabilitation and stroke research. Do not attempt any of these without checking with your medical provider. Unless you join me in agitating, when you need these therapies they won't be there.

What this blog is for:

My blog is not to help survivors recover, it is to have the 10 million yearly stroke survivors light fires underneath their doctors, stroke hospitals and stroke researchers to get stroke solved. 100% recovery. The stroke medical world is completely failing at that goal, they don't even have it as a goal. Shortly after getting out of the hospital and getting NO information on the process or protocols of stroke rehabilitation and recovery I started searching on the internet and found that no other survivor received useful information. This is an attempt to cover all stroke rehabilitation information that should be readily available to survivors so they can talk with informed knowledge to their medical staff. It lays out what needs to be done to get stroke survivors closer to 100% recovery. It's quite disgusting that this information is not available from every stroke association and doctors group.

Saturday, April 24, 2021

FDA OKs Brain-Computer Interface Device for Stroke Rehab — IpsiHand System

This very likely would not work for me, I essentially have no motor cortex for the left hand. It would seem that the only persons this could work for would be white matter damage preventing grey matter signals from getting out. And that would seem to be very rare not to damage both from the same stroke. But what the hell do I know, I'm not medically trained.

FDA OKs Brain-Computer Interface Device for Stroke Rehab — IpsiHand System

IpsiHand System designed for individuals with upper-extremity disability

by Nicole Lou, Staff Writer, MedPage Today April 23, 2021

FDA MARKETING IpsiHand Upper Extremity Rehabilitation System (IpsiHand System) over a computer rendering of the device

FDA has authorized the Neurolutions IpsiHand Upper Extremity Rehabilitation System (IpsiHand System) for stroke survivors trying to regain hand, wrist, or arm function.

The IpsiHand System may be prescribed to stroke patients wishing to improve grasping as part of their rehabilitation therapy. The brain-computer-interface device uses non-invasive electroencephalography electrodes to record a person's brain activity, and then moves an electronic hand brace according to the intended muscle movement.

"Thousands of stroke survivors require rehabilitation each year," said Christopher Loftus, MD, acting director of the Office of Neurological and Physical Medicine Devices at the FDA, in a statement. "Today's authorization offers certain chronic stroke patients undergoing stroke rehabilitation an additional treatment option to help them move their hands and arms again and fills an unmet need for patients who may not have access to home-based stroke rehabilitation technologies."

Approval was based on a 40-person unblinded study in which all participants showed motor function improvement with the device over 12 weeks. Adverse events reported in the study included minor fatigue, discomfort, and temporary skin redness.

The IpsiHand System had been granted breakthrough device designation by the FDA and was authorized for marketing through the de novo premarket review pathway.

The device should not be used by patients who cannot be properly fitted for the electronic hand brace, nor those with skull defects due to craniotomy or craniectomy, the FDA cautioned.