For people with paralysis caused by nerve injury or disease such as ALS (also known as Lou Gehrig’s disease), stroke, or spinal cord injury, the Brain Computer Interface (BCI) can help improve communication, mobility, and independence. It has the potential to restore sexuality by sending information directly from the brain to a computer or other assistive technology.
A core component of many brain-computer interfaces, implantable brain sensors have been used in animal neuroscience research for decades and are approved for short-term use (<30 days) in humans However, the long-term safety of this technique in humans is unknown.
New results from the prospective, open-label, nonrandomized BrainGate feasibility study, the largest and longest clinical trial of implantable BCIs, show that the safety of these sensors is similar to other long-term implantable neural devices suggests.
BrainGate’s clinical trial is run by a collaborative consortium of researchers from multiple institutions, including Massachusetts General Hospital (MGH), working to develop a BCI for people affected by neurological disorders and paralysis from injury. is.
This new report neurology An MGH-led team will study 14 adults with spinal cord injury, brainstem stroke, or ALS-induced quadriplegia (weakness in all four limbs) enrolled in the BrainGate trial through seven US clinical sites from 2004 to 2021. I researched the data. .
Participants underwent surgical implantation of one or two microelectrode arrays in parts of the brain that generate electrical signals that control limb movement. These “Utah” microelectrode arrays can be used to send brain signals associated with the intention to move a limb to a nearby computer. The computer decodes the signals in real time, allowing users to control external devices simply by thinking about moving their bodies. part of their body.
The study authors report that across the 14 enrolled study participants, the average duration of device implantation was 872 days, resulting in a total of 12,203 days for safety analysis. There were 68 device-related adverse events, including his 68 device-related serious adverse events.
The most common device-related adverse event was skin irritation around the part of the device that connects the implanted sensor to an external computer system. Importantly, they reported no safety events requiring removal of the device, no brain or nervous system infections, and no adverse events resulting in increased permanent disability associated with the investigational device.
“This interim report confirms that the investigational BrainGate neural interface system, which is still in ongoing clinical trials, has so far proven to be the most approved implantable neurological device, such as deep brain stimulators and responsive neurostimulators. It shows that it has a safety profile that is comparable to the device,” said the first author. Daniel Rubin, MD, PhD, is a Physician Investigator at the Center for Neurotechnology and NeuroRecovery (CTNR) in Neurology at MGH and an instructor in Neurology at Harvard Medical School.
“Given the recent rapid advances in this technology and continued performance improvements, these data suggest favorable risk/benefit ratios for well-selected individuals to support ongoing research and development.” doing.”
Daniel Rubin, MD
Leigh Hochberg, M.D., Ph.D., head of the BrainGate consortium and clinical trials and senior author of the article, said that as surgically-placed brain-computer interfaces progress through clinical research, the importance of ongoing safety analyzes. emphasized gender.
“Our consortium has published over 60 articles detailing the ever-advancing ability to harness neural signals for intuitive control of devices for communication and mobility, but not for safety. Prerequisite Hochberg, co-director of CNTR, Professor of Engineering at L. Herbert Barrow College at Brown University, and director of the VA RR&D Center for Neural Repair and Neuroengineering at the VA Providence Healthcare System. He is a senior lecturer in neurology at Harvard Medical School.
The extraordinary people participating in the ongoing BrainGate clinical trial and early trials of neurotechnology deserve tremendous credit. They don’t sign up for personal gain, they want to help. ”
Lee Hochberg, MD, PhD
Merit Cudkowicz, MD, MSc, Chief of Neurology at MGH, Director of the Sean M. Healey & AMD Center for ALS, and Julianne Dorn Professor of Neurology at Harvard Medical School praised the BrainGate study. “The breakthrough neurotechnology and clinical trials of her BCI are very exciting, especially when it comes to diseases like her ALS and spinal cord injury, which still have no cure,” she says. “Along with new drug platform trials, our Neuroengineering and Neurorestoration Center will continue to direct, execute and grow clinical trials that offer promising new ways to improve the quality of life of people with neurological disorders. We continue to lead.”
Massachusetts General Hospital
Rubin, DB, and others. (2023) Intermediate safety profile from a feasibility study of the BrainGate neural interface system. Neurology. doi.org/10.1212/WNL.0000000000201707.