overview: Research reports show that implanted brain-computer interfaces are similar in safety to conventional brain implants used to manage neurodegenerative diseases.
sauce: Mass in general
For people paralyzed by neurological injuries or diseases such as ALS (also known as Lou Gehrig’s disease), stroke, and spinal cord injury, the Brain Computer Interface (BCI) provides communication, mobility, and independence through communication. has the potential to recover. Send information directly from your 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 proved to be the most approved implantable neural device, such as deep brain stimulators and reactive neurostimulators. It shows that they have comparable safety profiles,” said the first author. Daniel Rubin, MD, Ph.D., is a physician in the Center for Neuroengineering and Nerve Recovery (CTNR) in the Department of 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.” I do,” Rubin says.
Leigh Hochberg, MD, 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 ongoing We emphasized the importance of safety analysis.
“Our consortium has published more than 60 articles detailing advances in the ability to harness neural signals for intuitive control of devices for communication and mobility, but safety is potentially It’s a prerequisite for any useful medical technology,” says Hochberg. Co-Director of CNTR and Brown University He is L. Herbert He is Professor of Engineering at the University of Barrow, VA Providence He is Director of the VA RR&D Center for Neural Repair and Neuroengineering in the Health Care System, Harvard He is Medical He is also a Senior Lecturer in Neurology at the School.
“The extraordinary people participating in the ongoing Braingate clinical trials and early trials of neurotechnology deserve tremendous credit. They want to help, not for personal gain. We register for a reason,” says Hochberg.
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.
“Our Neurotechnology and NeuroRecovery Center will direct, conduct and grow clinical trials that, alongside new drug platform trials, offer promising new ways to improve the quality of life of people with neurological disorders. We continue to lead.”
About this Neurotech Research News
author: press office
sauce: Mass in general
contact: Press Office – Misa General
image: image is public domain
Original research: open access.
“Preliminary Safety Profiles from a Feasibility Study of the BrainGate Neural Interface System” by Daniel Rubin et al. neurology
Preliminary Safety Profiles from a Feasibility Study of the BrainGate Neural Interface System
Background and purpose: The Brain Computer Interface (BCI) is being developed to restore locomotion, communication, and functional independence in people with paralysis. Although supported by decades of preclinical data, the human safety of chronically implanted microelectrode array BCI is unknown. We report safety results from a prospective, open-label, non-randomized Braingate feasibility study (NCT00912041), the largest and longest clinical trial of a transplanted BCI.
Method: Adults aged 18-75 years with spinal cord injury, brainstem stroke, or quadriplegia due to motor neuron disease were enrolled through seven US clinical sites. The participant underwent surgical implantation of one or two microelectrode arrays into the motor cortex of the dominant cerebral hemisphere. The primary safety outcome was a device-related serious adverse event requiring device explanation or an increase in death or permanent disability during the 1-year post-implantation evaluation period. Secondary outcomes include the type and frequency of other adverse events and the feasibility of the BrainGate system to control computers or other assistive technologies.
result: From 2004 to 2021, 14 adults enrolled in the BrainGate trial were surgically implanted with the device. The average duration of device implantation was 872 days, yielding 12,203 days of safety experience. 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 percutaneous pedestal. There were no safety events requiring removal of the device, unexpected device adverse events, intracranial infections, or participant deaths or adverse events leading to increased permanent disability associated with the study device.
Discussion: The BrainGate Neural Interface System has a safety record comparable to other long-term implantable medical devices. 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. I’m here.
Trial registration information: ClinicalTrials.gov Identifier: NCT00912041.
Classification of Evidence: This study evaluated the neurosurgically-placed BrainGate neural interface system, defined as leading to an increase in device explanation, death, or permanent disability 1 year after implantation. It provides class IV evidence that it is associated with the rate of SAE.