Safe and effective endovascular brain-computer interface in ALS

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A fully implanted endovascular brain-computer interface (BCI) continued to safely help people with amyotrophic lateral sclerosis (ALS) communicate at 1 year, according to data from the SWITCH trial.

The four ALS patients who had the endovascular motor neuroprosthesis achieved the study’s primary safety endpoints at 12 months, reported Douglas Weber, PhD, professor of bioengineering at Carnegie Mellon University in Pittsburgh, during a press briefing for the 2022 Annual Meeting of the American Academy of Neurology. .

As seen in an earlier feasibility study, participants were able to independently complete tasks such as text messaging, online shopping, and managing finances using the device.

This is the first endovascular BCI for people with severe paralysis, Weber noted.

A BCI is a device that measures and translates brain signals into computer commands. “These can be used for digital messaging, web browsing and other actions that allow people with severe paralysis to reconnect to the world,” Weber said.

“BCI technology has great potential to enable the more than 5 million people in the United States who are severely paralyzed to once again perform important activities of daily living,” Weber added.

Typically, implanting a BCI device requires surgery to remove part of the skull and place electrodes on the brain. The SWITCH trial tested a minimally invasive BCI that would reach the brain through vascular access without a craniotomy.

“It’s an endovascular BCI, meaning it’s delivered through a venous catheter using techniques common in neuro-interventional procedures,” Weber noted.

The BCI device was made of a mesh-like material with 16 sensors attached and was implanted with a catheter to guide placement in the superior sagittal sinus. It was connected to an electronic unit in the chest that relayed signals from the motor cortex into computer commands.

“The sensors are positioned on a stent-like scaffold that unfolds against the walls of the superior sagittal sinus, which is a large blood vessel that runs next to the medial edge of the primary motor cortex,” Weber said. “This device detects the electrical activity that occurs in the motor cortex when someone thinks about moving their limbs.”

“These movement signals are then transmitted to an external device, where they are decoded to form command signals which are sent to a computer, thus providing a direct communication link to the brain to express movement intention,” a- he continued.

All four participants in the SWITCH study completed the 12-month follow-up without any serious adverse events. Postoperative imaging showed patent blood vessels in all participants and no device migration.

The device has the potential to be used in other patients, not just those with ALS, Weber noted. “We’re starting with ALS, but our inclusion criteria include people with severe paralysis from any cause,” he said. “So someone with a brainstem stroke, for example, or a very high-level spinal cord injury, these are all people who can benefit from the digital communication capabilities supported by this technology. .”

Device maker Synchron is continuing its research in the United States and Australia and has won FDA approval to test its commercial BCI in humans ahead of other companies, including Elon Musk’s Neuralink. His upcoming COMMAND study of six severely paralyzed patients will be supported in part by the NIH.

  • Judy George covers neurology and neuroscience news for MedPage Today, writing about brain aging, Alzheimer’s disease, dementia, MS, rare diseases, epilepsy, autism, headaches , stroke, Parkinson’s disease, ALS, concussion, CTE, sleep, pain, etc. To follow

Disclosures

The study was supported by Synchron Inc., the device manufacturer, the US Defense Advanced Research Projects Agency, the Office of Naval Research, the National Health and Medical Research Council of Australia, the Australian Federal Government Foundation and the Motor Neurone Disease. Australian Research Institute.

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