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Trial Underway Testing Brain-Computer Implant

Stentrode implant

Stentrode implant (Synchron Inc.)

20 Sept. 2019. The first participant in a clinical trial received an experimental minimally-invasive brain implant to record brain signals, testing the implant’s feasibility for assistive technology. The trial is conducted in Australia by Synchon Inc., based in Melbourne and Campbell, California, developer of the Stentrode device being assessed.

The Stentrode is a small metallic wire mesh tube, similar to a stent. The device has electrodes on tiny disks inside the tube, placed in a blood vessel adjacent to the primary motor cortex that controls voluntary muscular movements in the body. However, instead of drilling a hole in the skull to implant the device, the electrode travels from a vein in the neck into the selected brain blood vessel. When the Stentrode reaches its destination, it expands to fill the blood vessel.

Once implanted, the Stentrode captures electric signals directed to the motor cortex to stimulate specific muscles in the body. Those same signals are sent from the Stentrode to a device implanted in the person’s chest called the brainPort that relays the signals to a nearby receiver. From the receiver, says Synchron, the signals are translated into computer-readable commands by another system component called brainOS for communication and to restore limb functions.

“By using veins as a naturally-existing highway into the brain,” says Thomas Oxley, Synchon’s founder and CEO in a company statement, “we have been able to reach the clinical stage significantly earlier than other more invasive approaches.” Oxley is also a neurology professor at University of Melbourne.

Synchron tested the system in preclinical studies with colleagues at University of Melbourne. Science & Enterprise reported on one of those studies in December 2018, published in the journal Nature Biomedical Engineering. In that report, researchers inserted Stentrodes in brains of sheep and directed the electrodes to stimulate facial and limb muscles in the animals. The results show the appropriate sheep muscles responded on demand, similar to electrodes implanted surgically.

The early-stage clinical trial is recruiting five individuals in Melbourne with loss of motor function due to limb loss or paralysis from spinal cord injury, motor neuron diseases such as ALS, stroke, or muscular dystrophy. Participants will be followed for 12 months, looking primarily for signs of adverse effects. However, the study is also tracking the quality and stability of the signals transmitted from the Stentrodes.

“What we learn from the first-in-human clinical trial will be highly valuable in guiding our device design and clinical protocol for a pivotal trial in the U.S.,” notes Oxley.

Synchron is developing brainOS into a collection of apps to help patients restore lost speech and limb functions, strictly by channeling their thoughts captured on Stentrodes to direct movement of specific muscles, without a mouse or keyboard. “By reimagining the concept of the operating system,” adds Oxley, “we have designed our technology platform to enable a completely hands-free user experience.”

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