The study shows that brain-computer interfaces are similar to other implanted neurological devices in terms of safety.
For people with paralysis resulting from a neurological injury or disease, such as ALS (also known as Lou Gehrig’s disease), stroke or spinal cord injury, brain-computer interfaces (BCIs) offer a chance to restore speech, mobility, and physical independence. It transfers information directly from the brain to a computer or other assistive technology, writes News Medical.
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An essential component of many brain-computer interfaces, implanted brain sensors have been used in animal neuroscience research for decades and have been approved for short-term (less than 30 days) use in humans, although the long-term safety of this technology in the human body has yet to be confirmed.
New results from the largest and longest-term clinical trial testing an implanted BCI show that the safety of these sensors is similar to that of other permanently implanted neurological devices.
The clinical trials are being led by a joint consortium of researchers from several institutions, including Massachusetts General Hospital, who are developing BCIs for people suffering from stroke caused by neurological disease or injury.
This new report looked at 14 adults with quadriparesis (weakness in all four limbs) due to spinal cord injury, brainstem palsy or ALS.
Participants underwent surgical implantation of one or two microelectrode arrays in the part of the brain responsible for generating electrical signals that control limb movement. With these Utah microelectrode arrays, brain signals associated with intent to move a limb can be sent to a nearby computer, which decodes the signal in real time and allows the user to control an external device by simply thinking of moving a body part.
The study authors reported that the mean device implantation time among the 14 study participants was 872 days, with a total of 12,203 days for implant safety analysis. There were 68 device-related adverse events, including 6 serious device-related adverse events.
The most common side effect associated with the device was skin irritation around the part of the device that connects the implanted sensor to the external computer system. More importantly, they report no safety-related adverse events requiring device removal, brain or nervous system infections, or adverse events leading to permanent worsening of working device-related disability.
“This interim report demonstrates that the neural interface system currently in clinical trials and under investigation has a level of safety comparable to many approved implanted neurostimulators, such as deep brain stimulators and precision neurostimulators. Research physician and neuroscientist at the Center for Neurotechnologies and Neurorecovery. “Continued improvement in technology and performance, these data show a positive risk-benefit ratio in the right individuals to support ongoing research and development,” says lead author Daniel Rubin, PhD, professor of medicine at Harvard Medical School.
The paper’s senior author, MD Lei Hochberg, stressed the importance of continued safety review as surgically implanted brain-computer interfaces advance clinical research findings.
“While our consortium has published over 60 papers detailing the ever-evolving possibilities of using neural signals to intuitively control communication and motion devices, security indispensable any potentially useful medical technology. The outstanding people involved in our ongoing clinical trials and early trials of any neurotechnology deserve a great deal of credit. They do this not for personal gain or glory, but because they want to help,” says Hochberg.
Merit Kudkowicz, MD, MS, and Harvard Medical School professor of neuroscience Julianne Dorn welcomed the study.
“Clinical trials of innovative neurotechnologies and BCIs are incredibly exciting, especially for diseases that still have no cure, such as ALS or spinal cord injury,” says Dorn. “In addition to platform trials for new drugs, our Center for Neurotechnologies and Neurorecovery continues to lead, conduct and expand clinical trials that provide promising new ways to improve the quality of life of people with neurological diseases.”
Previously Focus He wrote that he created the world’s first brain implant to treat depression. The Inner Cosmos digital tablet is powered by a smartphone app that also displays mood and depression charts that you can share with your doctor.
Source: Focus
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