Brain-computer interface ahead of Musk’s brain-computer interface company Synchron announced that it will conduct the first human clinical trial in the United States

  Brain-computer interface company Synchron announced that it has recruited its first patient in the United States to conduct a clinical trial using the company’s BCI implant called “Stentrode,” and hopes to use Stentrode to help the severely paralyzed patient. Life becomes more convenient.
  The Stentrode used in this clinical trial is a brain-computer interface device implanted inside a blood vessel, which is also one of Synchron’s most critical technologies. Paralyzed patients are expected to use the device to wirelessly control electronic devices with consciousness, enabling them to perform certain daily tasks independently of others, such as texting, emailing and online shopping.
  The Stentrode brain-computer interface implant is implanted through the jugular vein. The technology used for implantation is the neurointerventional technology commonly used to treat stroke. The biggest advantage of this technology is that it does not require drilling into the skull or craniotomy. . The company said that the device is primarily designed for paralyzed patients, and the company has designed the product to be more convenient and reliable, and patients can independently control electronic devices through Stentrode.
  By contrast, competing devices from Musk’s Neuralink are less invasive, and Neuralink’s brain-computer interface technology needs to be implanted directly from a patient’s skull, which can lead to long-term inflammation in the patient’s brain.
  But compared to Synchron, Neuralink is more well-funded, raising $205 million in 2021, while Synchron has raised a total of $70 million.
  About the size of a paper clip, the Stentrode brain-computer interface implant has a stent made of a flexible alloy called nitinol. The scaffold also includes electrodes to record nerve signals in the brain.
  Implanting Stentrode in a patient requires minimally invasive surgery. First, doctors make small, keyhole-sized incisions in the patient’s neck, similar to minimally invasive surgery for heart bypass surgery. The implant is then passed through the incision into a blood vessel near the throat, from where it travels up to the brain.
  Once the Stentrode implant reaches a blood vessel in the brain above the motor cortex, the Stentrode expands and presses the electrodes against the wall of the blood vessel close to the brain, where the recording of neural signals takes place. Next, the implant monitors activity information in the brain and sends brain waves to the device on the user’s chest. According to the company, the entire implantation process can be completed within two hours.

  After the Stentrode is implanted, the patient’s brain command center is theoretically connected directly to the software, and the patient will then gradually try to train their brain to directly control the operating system.
  Recently, Synchron began the world’s first human clinical trial of a brain-computer interface, called the “COMMAND trial,” funded by the National Institutes of Health and granted an Investigational Device Exemption (IDE) by the U.S. Food and Drug Administration.
  Tom Oxley, CEO and founder of Synchron, said that what it has obtained is the world’s first IDE for permanent brain-computer interface implants. Although some brain-computer interface devices have obtained IDE before, those are not permanent implants. entered. He also said that Stentrode’s acquisition of IDE as a BCI permanent implant is an important milestone as Stentrode could potentially bring a solution to the 5 million paralyzed patients in the United States in the future.
  In addition, this COMMAND trial is an early feasibility trial for Stentrode. The trial will systematically evaluate the safety of Stentrode and explore the quantitative efficacy of Stentrode in patients, with the goal of helping patients achieve independent control of electronic devices.
  The COMMAND trial will be conducted in New York and Pittsburgh, Pennsylvania, and will involve approximately six patients. The first patient in the trial is currently enrolled at Mount Sinai Hospital in New York.
  The safety of the device has been proven previously in an Australian study called “SWITCH”. The COMMAND trial will be the first human trial of the device in the United States.
  In the SWITCH study in Australia, the device underwent its first human research trial. The SWITCH study monitored four patients with Stentrode implanted for 1 year, and the device proved to be safe, with no events leading to disability or death during the monitoring period.

Synchro’s brain-computer interface endovascular implant Stentrode

  A year later, the staff monitored the implants in four patients and found that the implants remained in place and the blood vessels in which the devices were implanted were clear. In addition, during the implant monitoring period, patients can send text messages, shop online and manage finances through the Stentrode system without relying on others at home.
  Speaking at the American Academy of Neurology Annual Meeting in March 2022, Professor Bruce Campbell said: “Through the SWITCH study, the long-term safety of Stentrode as a permanent implant for an endovascular brain-computer interface in severely paralyzed patients has been tentatively demonstrated. ”
  Stentrode is a motor prosthesis, that is, an artificial device that replaces certain motor functions that are impaired due to disease. Currently, the BCI implant is designed to process signals from parts of the brain associated with movement, but the company’s ultimate goal is to process all signals from all areas of the brain.
  In addition to developing endovascular implants, the company is also developing a neuroprosthesis for the treatment of paralysis. The company plans to develop solutions for the diagnosis and treatment of other neurological disorders in the future, including Parkinson’s disease, epilepsy, depression and hypertension, among others.

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