Action, Elon Musk. Synchron, a competitor to Neuralink, has achieved an important milestone for the field of brain-computer interface (BCI) with a first-person human implant in the US 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 approach, led by Shahram Majidi, MD, an assistant professor of neurosurgery, neurology, and radiology at the Icahn School of Medicine in Mount Sinai. The procedure is performed in the angiography suite with a minimally invasive, endovascular approach.
“This is a very exciting milestone for the field, because of its implications and huge potential,” Majidi said. “The implantation procedure was very good, and the patient was able to go home 48 hours after the operation.”
The FDA granted Synchron an exemption to the probe device in 2021 to study Stentrode, a brain-computer interface designed to enable patients to wirelessly control digital devices by mindfulness. and improve independence. The US -based COMMAND trial was 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 effectiveness of Synchron’s motor brain-computer interface technology platform, including Stentrode, in patients with severe paralysis with the goal of controlling digital devices without hands. The results of the study include the use of brain data to control digital devices and achieve improvements in functional independence.
“We are even more excited to work with our patient, guiding them through the training process as they learn to use this tool to live more independently and, most of all, communicate with their family and friends, ”said David Putrino, PhD, director of rehabilitation innovation for Mount Sinai Health System and a lead investigator in the COMMAND study.
Stentrode is inserted within the motor cortex of the brain through the jugular vein in a minimally-invasive endovascular procedure. Once implanted, it can detect and wirelessly transmit motor intent using proprietary digital language to allow severely paralyzed patients to control personal devices using hands-free point-and-click. The test will examine the impact of daily tasks such as texting, emailing, shopping online and accessing telehealth services, and the ability to live independently. The FDA granted Synchron a breakthrough device designation in August 2020.
“The first-in-person 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 are excited to advance a scalable BCI solution to the market, a with the potential to change many lives.
Synchron plans to continue enrolling 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 show that this brain-computer interface technology is safe in four patients for up to 12 months in Synchron’s SWITCH trial in Australia, as reported by the 2022 American Academy of Neurology conference.
Synchron has always 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 the C round series 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 and federal lawsuit against the University of California, Davis, for violations of the federal Animal Welfare Act with related to “invasive and deadly brain experiments” conducted on 23 monkeys. UC Davis received more than $ 1.4 million from Neuralink to conduct the experiments, according to the complaint.
Citing documents obtained in 2021 through a public records case, the complaint states that most animals have parts of their skulls removed to implant electrodes in their brains as part of development of Neuralink in a brain-computer interface. The group also filed a second case on public records in Yolo County Superior Court in an attempt to obtain videos and photos of the monkeys.
Neuralink responded to the allegations in a blog post on its website, although it was unclear when the post was published.
“Recent articles have raised questions about the use of Neuralink in animal research 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 on animals before they can be ethically tested by humans. Neuralink is not unique in this regard, “the company said. “At Neuralink, we are fully committed to working with animals in the most humane and ethical way possible.”
The Committee of Physicians accused Neuralink and UC Davis staff of failing to provide the dying monkeys with adequate veterinary care, “using an unapproved substance known as BioGlue that killed the monkeys by to destroy parts of their brains, ”and failed to provide for the psychological well-being of the monkeys assigned to the experiment. BioGlue, a surgical adhesive made by CryoLife, has been approved by the FDA, contrary to the Physician Committee’s press release.
The group says the Macaque monkeys used in the experiment were confined alone, had iron poles broken in their skulls, suffered “facial trauma,” attacks after the implant brain, and recurrent infections of implant sites. In some cases, as a result of deteriorating health, Neuralink and UC Davis euthanized the monkeys before they were used in the planned experiment, the group said.
“UC Davis may be handing over publicly funded facilities to a billionaire, but that doesn’t mean it avoids transparency requirements and violates federal animal welfare laws,” said Jeremy Beckham, research advocacy coordinator on the Physicians Committee. “Documents reveal that the monkeys were brainwashed in bad experiments and left to suffer and die. It’s no mystery why Elon Musk and the university wanted to hide from the public the photos and videos of this horrific abuse.
In a statement issued by MD+DI, UC Davis confirmed that it has a research collaboration with Neuralink, completed in 2020, and that the research protocols have been fully reviewed and approved by the Institutional Animal Care and Use Committee (IACUC) on campus. The work was done by Neuralink researchers at the facilities of the California National Primate Research Center at UC Davis. UC Davis staff provides veterinary care including full-time monitoring of experimental animals. If an incident occurs, it is reported to the IACUC, which mandates training and protocol changes if necessary, according to the statement.
“We strive to provide the best possible animal care in our capacity. Animal research is strictly regulated, and UC Davis complies with all applicable laws and regulations including those in the U.S. Department of Agriculture, which conducts regular inspections, and the 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 nonprofit 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 says in its blog post that initial studies at UC Davis used animal carcasses and terminal methods (animals that are considered healthy enough for an anesthetic event but may not be appropriate). quality of life due to a pre-existing condition).
“These animals were assigned to our project on the day of operation for our terminal procedure because they had many pre-existing conditions unrelated to our research,” Neuralink said in the blog post. “In addition to pre-existing conditions these animals can happen to lose digits throughout their lives from conflicts with other monkeys. The lost numbers are often the result of rhesus macaques resolving in conflict through aggressive interactions with each other … No such injuries occurred at any time to the animals placed at UC Davis while part of the Neuralink project. “
The company said the initial work from these procedures allowed Neuralink to develop its surgical and robotic procedures, building more secure protocols for subsequent surgeries to survive. Safety studies have allowed the company to test the functionality of different generations of implanted devices as it refines them for human use.
“The use of each animal is widely planned and considered to balance scientific discovery with the ethical use of the animals. As part of this work, two animals were euthanized on planned end dates to collect important histological data, and six animals were euthanized on medical advice.advice of veterinary staff at UC Davis.These factors include a surgical complication involving the use of the FDA-approved product ( BioGlue), a device failure, and four suspected device-related infections, a risk present in any percutaneous medical device.response we have developed new surgical protocols and a complete planted device design for future operations. “