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Synchron Launches First-in-U.S. Human Clinical Trial of Stentrode Brain-Computer Interface

May 05, 2022 17:21 CST Updated 17:21
Synchron

Developer of implantable neural interface products

Icahn School of Medicine at Mount Sinai

The Icahn School of Medicine at Mount Sinai is a private medical school in New York City, established by Mount Sinai Hospital. Its main building was designed by the renowned architect I. M. Pei. The school ranks 18th in research, 39th in primary care, and 1st in geriatrics among U.S. medical schools according to U.S. News & World Report. It ranks second nationwide in average NIH research funding per faculty member.At its inception, the school was affiliated with the City University of New York. In 1999, it became affiliated with New York University, though it did not merge with the NYU School of Medicine. In 2007, Mount Sinai separated from NYU, and in 2010, it received accreditation to independently confer degrees.

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According to Teslarati, on May 4 (local time), Synchron, a competitor of Neuralink, announced the initiation of its first-in-human clinical trial in the United States, known as the COMMAND study. The first patient enrolled in the COMMAND trial participated at Mount Sinai Hospital in New York.

Synchron-how-it-works-768x499

“The COMMAND study has advanced the technical development of Synchron’s technology into the feasibility stage, as we prepare for our pivotal trial,” said Tom Oxley, MD, CEO and Founder of Synchron. “The enrollment of the first patient under the Investigational Device Exemption (IDE) for permanently implanted brain-computer interface (BCI) research devices marks a significant milestone for the entire field, as we advance solutions for the 5 million paralyzed patients in the United States.”

Synchron has developed a device called the Stentrode to help patients with severe paralysis. The company’s goal is to enable patients to control digital devices without using their hands, via a brain implant placed within blood vessels. The Stentrode is threaded through the jugular vein until it reaches the brain. Made of a mesh material with 16 sensors, it expands against the vessel wall. Synchron’s Stentrode connects to an electronic device in the chest that relays brain signals from the motor cortex.

“Our research is exciting because other devices require craniotomy, whereas this brain-computer interface device is much less invasive. It receives electrical signals from the brain, enabling people to control computers through thought,” noted Bruce Campbell, M.D.

In contrast, Neuralink’s device is implanted directly into the brain by a robot resembling a computer numerical control (CNC) machine. The device consists of a spherical component connected to flexible, hair-thin electrodes.

During its SWITCH clinical trial, Synchron successfully conducted human trials on four patients in Australia. Bruce Campbell is the author of the research report documenting Synchron’s human trials in Australia. The researchers monitored participants in the SWITCH trial for a full year. They observed that the Stentrode was safe, as the trial resulted in “zero adverse events.”

During the SWITCH trial in Australia, all four patients used the Stentrode device. They used Synchron’s device at home without supervision. The patients were also able to send text messages, shop online, and manage their finances on the internet. In December 2021, Synchron patient Philip O’Keefe successfully posted a tweet using the Stentrode for the first time.

Source:cnBeta

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