Move over, Elon Musk. Neuralink rival Synchron has achieved a major brain-computer interface (BCI) milestone with the first American implant in humans using an endovascular brain-computer interface approach, which does not require invasive open-brain surgery.
Clinical investigators from Mount Sinai Health System in New York, NY, performed the landmark procedure, led by Shahram Majidi, MD, 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 step for the field, because of its implications and huge potential,” Majidi said. “The implant procedure went extremely well and the patient was able to go home 48 hours after the operation.”
The FDA granted Synchron an investigational device exemption in 2021 to study the Stentrode, a brain-computer interface designed to allow patients to wirelessly control digital devices by thought and improve functional independence. The US-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 evaluate 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 hands-free digital devices. Study results include the use of brain data to control digital devices and improve functional independence.
“We are beyond excited to work with our patients, guiding them through the training process as they learn to use this device to live more independently and most importantly communicate with family and friends,” said David Putrino, PhD, director. Rehabilitation Innovation for Mount Sinai Health System and Principal Investigator of the COMMAND Study.
The Stentrode is implanted into the motor cortex of the brain via the jugular vein in a minimally invasive endovascular procedure. Once implanted, it wirelessly senses and transmits motor intent using a proprietary digital language to allow severely paralyzed patients to control their 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, as well as the ability to live independently. The FDA granted Synchron Breakthrough Device Designation in August 2020.
“The first human implant of an endovascular [brain-computer interface] in the United States is a major clinical milestone that opens up new possibilities for patients with paralysis,” said Tom Oxley, MD, PhD, CEO and Founder of Synchron. “Our technology is for the millions of people who have lost the ability to use their hands to control digital devices. We are thrilled to bring a scalable BCI solution to market, which has the potential to transform so many lives.
Synchron plans to continue advancing enrollment in its COMMAND trial as the first FDA-approved clinical trial for a permanently implanted brain-computer interface in the United States. Recently reported long-term safety results demonstrated that this brain-computer interface technology was safe in four patients over 12 months in Synchron’s SWITCH trial in Australia, as reported at the 2022 American Academy conference of Neurology.
Synchron has often been touted as a direct competitor to Musk’s Neuralink. Neuralink, based in San Francisco, Calif., 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 founder 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 lawsuit and federal complaint against the University of California, Davis, for violating federal animal welfare law. linked to “invasive and deadly brain experiments” carried out 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 as part of a lawsuit, the complaint alleges that most of the animals had parts of their skulls removed to implant electrodes in their brains as part of Neuralink’s development of an interface. brain-computer. The group also filed a second lawsuit against public records in Yolo County Superior Court in an attempt to obtain videos and photographs of the monkeys.
Neuralink addressed the allegations in a blog post on its website, although when the post was published is unclear.
“Recent articles have raised questions about 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 new medical devices and treatments must be tested on animals before they can be ethically tested on humans. Neuralink is not unique in this regard,” the company states. “At Neuralink, we we are absolutely committed to working with animals in the most humane and ethical way possible.”
Physicians’ 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 has killed monkeys by destroying parts of their brains”, and failing to ensure the psychological well-being of monkeys assigned to the experiment. BioGlue, a surgical adhesive manufactured by CryoLife, is FDA cleared, contrary to the Physician Committee press release.
The group says the macaque monkeys used in the experiment were caged alone, had steel poles screwed to their skulls, suffered ‘facial trauma’, seizures from brain implants and recurring infections on their implantation sites. In some cases, due to deteriorating health, Neuralink and UC Davis euthanized monkeys before they were even used in the planned experiment, according to the group.
“UC Davis may have handed over its state-funded facility 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. “Documents reveal monkeys had their brains mutilated in shoddy experiments and 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 DM+DI, UC Davis confirmed that it had a research collaboration with Neuralink, which ended in 2020, and that the research protocols were carefully reviewed and approved by the Institutional Animal Care and Use Committee (IACUC ) from campus. The work was conducted by Neuralink researchers at facilities at the California National Primate Research Center at UC Davis. UC Davis staff provided veterinary care, including round-the-clock monitoring of laboratory animals. When an incident occurred, it was reported to the IACUC, which imposed training and protocol changes as needed, according to the statement.
“We strive to provide the best care possible for the animals in our care. Animal research is strictly regulated, and UC Davis follows all applicable laws and regulations, including those of the United States Department of Agriculture, which performs regular inspections, and NIH Office of Laboratory Animal Welfare.UC Davis’ animal care program, including the California National Primate Research Center (CNPRC), is accredited by AAALAC International , a non-profit organization,” UC Davis said in the statement.
The university also noted that as a national center for primate research, the CNPRC is a resource for public and private sector researchers.
Neuralink states in its blog post that initial studies at UC Davis used cadaver animals and terminal procedures (animals that were deemed healthy enough for an anesthetic event but may not have a quality of appropriate life due to a pre-existing condition).
“These animals were assigned to our project on the day of 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 lost digits throughout their lives due to conflicts with other monkeys. Missing digits are often the result of rhesus macaques resolving conflicts through aggressive interactions with each other. others… No such injury has occurred at any time to animals housed at UC Davis as part of the Neuralink project.”
The company said the initial work on these procedures allowed Neuralink to grow its surgical and robotic procedures, establishing safer protocols for later life-saving surgeries. Survival studies then allowed the company to test the function of different generations of implanted devices while refining them for human use.
“The use of each 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 scheduled end dates to collect important histological data, and six animals were euthanized in the hospital opinion of UC Davis veterinary staff.These reasons included a surgical complication involving the use of the FDA-approved product (BioGlue), device failure, and four infections associated with the suspected device, a risk inherent in any percutaneous medical device. In response, we have developed new surgical protocols and a fully implanted device design for future surgeries.”