Posted on: July 20, 2022 Posted by: AKDSEO Comments: 0

Move over, Elon Musk. Synchron, a rival to Neuralink, has achieved a major milestone for the brain-computer interface (BCI) field with the first-in-human U.S. implant using an endovascular brain-computer interface approach, which does not require invasive open-brain surgery.

Clinical investigators at Mount Sinai Health System in New York, NY performed the historic procedure, led by Shahram Majidi, MD, an assistant professor of neurosurgery, neurology, and radiology at the Icahn School of Medicine at Mount Sinai. The procedure was performed in the angiography suite with a minimally invasive, endovascular approach.

“This is an incredibly exciting milestone for the field, because of its implications and huge potential,” Majidi. “The implantation procedure went extremely well, and the patient was able to go home 48 hours after the surgery.”

Image courtesy of Synchron

FDA awarded Synchron an investigational device exemption in 2021 to study the Stentrode, a brain-computer interface designed to enable patients to wirelessly control digital devices through thought and improve functional independence. The U.S.-based COMMAND trial is being conducted with support from the NIH Neural Interfaces Program in the form of a $10 million grant.

The COMMAND study will assess the safety and efficacy of Synchron’s motor brain-computer interface technology platform, including the Stentrode, in patients with severe paralysis with the goal of enabling the patient to control digital devices hands-free. Study outcomes include the use of brain data to control digital devices and achieve improvements in functional independence.

Image courtesy of SynchronThe Stentrode Endovascular Electrode Array and Implantable Receiver Transmitter Unit

“We are beyond excited to get to work with our patient, guiding them through the training process as they learn to use this device to live more independently and, most importantly, communicate with their family and friends,” said David Putrino, PhD, director of rehabilitation innovation for the Mount Sinai Health System and a principal investigator of the COMMAND study.

The Stentrode is implanted within the motor cortex of the brain via the jugular vein in a minimally-invasive endovascular procedure. Once implanted, it detects and wirelessly transmits motor intent using a proprietary digital language to allow severely paralyzed patients to control personal devices with hands-free point-and-click. The trial will assess the impact of everyday tasks such as texting, emailing, online shopping and accessing telehealth services, and the ability to live independently. The FDA granted Synchron a breakthrough device designation in August 2020.

“The first-in-human implant of an endovascular [brain-computer interface] in the U.S. is a major clinical milestone that opens up new possibilities for patients with paralysis,” said Tom Oxley, MD, PhD, Synchron’s CEO and founder. “Our technology is for the millions of people who have lost the ability to use their hands to control digital devices. We’re excited to advance a scalable BCI solution to market, one that has the potential to transform so many lives.”

Synchron plans to continue to advance enrollment in its COMMAND trial as the industry’s first FDA-approved clinical trial for a permanently implanted brain-computer interface in the United States. Recently reported long-term safety results have demonstrated this brain-computer interface technology to be safe in four patients out to 12 months in Synchron’s SWITCH trial in Australia, as reported at the 2022 American Academy of Neurology conference.

Synchron has often been framed as a direct competitor to Musk’s Neuralink. San Francisco, CA-based Neuralink was founded in 2016. In July 2021, the company said it raised $205 million in a series C round from investors including Google Ventures, Peter Thiel’s Founders Fund, and OpenAI CEO Sam Altman.

Neuralink accused of ‘deadly’ brain-computer interface experiments in monkeys

Earlier this year, the Physicians Committee for Responsible Medicine, a national nonprofit group, filed a state lawsuit and federal complaint against the University of California, Davis, for violations of the federal Animal Welfare Act related to “invasive and deadly brain experiments” conducted on 23 monkeys. UC Davis received more than $1.4 million from Neuralink to carry out the experiments, according to the complaint.

Citing documents obtained in 2021 through a public records lawsuit, the complaint alleges that most off the animals had portions of their skulls removed to implant electrodes in their brains as part of Neuralink’s development of a brain-computer interface. The group also filed a second public records lawsuit in Yolo County Superior Court in an effort to obtain videos and photographs of the monkeys.

Neuralink addressed the allegations in a blog post on its website, although it is not clear when the post was published.

“Recent articles have raised questions around Neuralink’s use of research animals at the University of California, Davis Primate Center. It is important to note that these accusations come from people who oppose any use of animals in research. Currently, all novel medical devices and treatments must be tested in animals before they can be ethically trialed in humans. Neuralink is not unique in this regard,” the company states. “At Neuralink, we are absolutely committed to working with animals in the most humane and ethical way possible.”

The Physician Committee accuses Neuralink and UC Davis staff of failing to provide dying monkeys with adequate veterinary care, “using an unapproved substance known as BioGlue that killed monkeys by destroying portions of their brains,” and failing to provide for the psychological well-being of monkeys assigned to the experiment. BioGlue, a surgical adhesive manufactured by CryoLife, is approved by FDA, contrary to the Physician Committee’s press release.

The group says that Macaque monkeys used in the experiment were caged alone, had steel posts screwed to their skulls, suffered “facial trauma,” seizures following brain implants, and recurring infections at implant sites. In some cases, as a result of deteriorating health, Neuralink and UC Davis euthanized monkeys before they were even used in the planned experiment, the group says.

“UC Davis may have handed over its publicly-funded facilities to a billionaire, but that doesn’t mean it can evade transparency requirements and violate federal animal welfare laws,” says Jeremy Beckham, research advocacy coordinator with the Physicians Committee. “The documents reveal that monkeys had their brains mutilated in shoddy experiments and were left to suffer and die. It’s no mystery why Elon Musk and the university want to keep photos and videos of this horrific abuse hidden from the public.” 

In a statement provided to MD+DI, UC Davis confirmed that it did have a research collaboration with Neuralink, which concluded in 2020, and that the research protocols were thoroughly reviewed and approved by the campus’s Institutional Animal Care and Use Committee (IACUC). The work was conducted by Neuralink researchers in facilities at the California National Primate Research Center at UC Davis. UC Davis staff provided veterinary care including round-the-clock monitoring of experimental animals. When an incident occurred, it was reported to the IACUC, which mandated training and protocol changes as needed, according to the statement.

“We strive to provide the best possible care to animals in our charge. Animal research is strictly regulated, and UC Davis follows all applicable laws and regulations including those of the U.S. Department of Agriculture, which makes regular inspections, and the NIH Office of Laboratory Animal Welfare. The UC Davis animal care program, including the California National Primate Research Center (CNPRC), is accredited by AAALAC International, a nonprofit organization,” UC Davis said in the statement.

The university also noted that as a national primate research center, the CNPRC is a resource for both public and private sector researchers.

Neuralink states in its blog post that initial studies at UC Davis used animal cadavers and terminal procedures (animals that have been deemed healthy enough for one anesthetic event but may not have proper quality of life due to a pre-existing condition).

“These animals were assigned to our project on the day of the surgery for our terminal procedure because they had a wide range of pre-existing conditions unrelated to our research,” Neuralink said in the blog post. “In addition to pre-existing conditions these animals may have happened to lose digits throughout their life from conflicts with other monkeys. Missing digits are often a result of rhesus macaques resolving conflict through aggressive interactions with one another … No such injuries occurred at any time to animals housed at UC Davis while part of Neuralink’s project.”

The company said the initial work from these procedures allowed Neuralink to develop its surgical and robot procedures, establishing safer protocols for subsequent survival surgeries. Survival studies then allowed the company to test the function of different generations of implanted devices as it refined them toward human use.

“The use of every animal was extensively planned and considered to balance scientific discovery with the ethical use of animals. As part of this work, two animals were euthanized at planned end dates to gather important histological data, and six animals were euthanized at the medical advice of the veterinary staff at UC Davis. These reasons included one surgical complication involving the use of the FDA-approved product (BioGlue), one device failure, and four suspected device-associated infections, a risk inherent with any percutaneous medical device. In response we developed new surgical protocols and a fully implanted device design for future surgeries.”