(ORDO NEWS) — Implanted brain sensors are now a core component of many brain-computer interfaces, have been used in animal neuroscience research for decades, and have been approved for short-term use (up to one month) in humans.
Yet the long-term safety of this technology in the human body has not yet been confirmed.
The authors of the new paper report that it is clear from the largest and longest-running clinical trial testing an implanted brain computer that the safety of these sensors is similar to that of other permanently implanted neurological devices.
The clinical trials were carried out by a collaborative consortium of researchers from several institutions, including Massachusetts General Hospital, who are developing brain implants for people suffering from paralysis caused by neurological disease or spinal cord injury and brainstem stroke.
Among the 14 study participants, the median duration of device implantation was 872 days, giving a total of 12,203 days for implant safety analysis. There were 68 device-related adverse events, including 6 serious adverse events.
The most common adverse event associated with the device was skin irritation around the part of the device that connects the implanted sensor to the external computer system.
It is important to note that the authors of the study report no serious incidents associated with the study device that would require removal of the device, infections of the brain or nervous system, and adverse events leading to permanent disability.
Therefore, according to study lead author Daniel Rubin, MD, research physician at the Center for Neurotechnology and Neurorecovery and professor of neurology at Harvard Medical School, “The interim report demonstrates that the neural interface system under investigation, which is still in ongoing clinical trials, has a high security level.
Contact us: [email protected]