Elon Musk of Neuralink announced this week that clinical trials on humans have commenced for his PRIME study (Precise Robotically Implanted Brain-Computer Interface), a medical device trial using a wireless brain-computer interface that aims to enable people with paralysis to control external devices with their thoughts.
According to Bradley Greger, a professor of neurotechnology at Arizona State University, he stated that „this technology will be a real game-changer.“
Greger, who is currently researching how deep brain stimulation (DBS) can treat patients with movement and pain disorders, noted that „Neuralink uses different technologies to record thousands of channels,“ while his current work only involves several channels.
As a neuroengineer, Greger has provided insights into the potential outcomes of Neuralink’s PRIME study.
Question: How accessible will this technology be for other researchers?
Answer: That depends on Neuralink. They have the technology, but many researchers are eager to have access to it.
Q: Is Neuralink currently working with a research hospital?
A: Yes, they have collaborated with a major neurosurgery center for their first patient study, but the details are kept confidential for privacy and security reasons.
Q: Do you believe that Neuralink will soon collaborate with additional neurological research institutions?
A: Yes, it seems likely. They may look to partner with institutions that have surgical expertise and supportive infrastructure for their research.
Q: Must each of the partner institutions go through the FDA approval process?
A: Probably not, as the technology and procedures are already FDA approved. However, each partner will undergo an Institutional Review Board (IRB) process at their own facility.
Q: Will the first study focus exclusively on paralysis patients?
A: Yes, it seems that the initial research partnerships will focus on restoring movement in patients with paralysis, such as those with ALS or severe spinal cord injuries.
Q: How long do you think it will take for the trial version to be expanded?
A: This phase of the study is expected to last about one to two years. If successful, Neuralink may move on to feasibility studies and safety testing within the next few years.
Q: If Neuralink goes beyond paralysis studies, will the company need to go through the FDA approval process again for a speech restoration study?
A: Additional IRB approvals may be necessary, but the process would be less complex than obtaining approval for the device itself.
Q: How long do you think it will take for Neuralink’s technology to be available to the general public?
A: The technology could be generally available in a few years, primarily for patients with neurologic disorders. However, the use of it for healthy individuals may require further consideration and approvals.
Arizona State University (ASU)