“Patients shouldn’t be forced to have device implants,” says Nita Farahaney, a legal scholar and ethicist at Duke University in North Carolina and author of a book on nerve rights.
“If there is evidence that a brain-computer interface can become part of the human self, it should not be permissible to implant the BCI without the user’s consent under any conditions other than medical necessity. I don’t think so,” Jenka says. “If it’s what constitutes the person, you basically remove something that constitutes the person against the person’s will.” It is likened to the forced removal of an organ that has been damaged.
Mark Cook, a neurologist who was involved in the trial in which Leggett volunteered, said the company’s effort was “ahead of its time.” “I get a lot of calls about this. A lot of people ask how bad it was,” he says. But Cook feels that such results are always possible in clinical trials of drugs and medical devices. He stresses that it’s important for participants to be fully aware of these possibilities before participating in such trials.
But Jenka and Gilbert think something needs to change. Companies should take out insurance to cover device maintenance, for example, in case volunteers need to keep the device after a clinical trial is completed. Alternatively, the state could step in and provide the necessary funding.
Burkhardt has his own proposal. “These companies have to somehow take responsibility for supporting these devices,” he says. At the very least, he said, companies should set aside funds for ongoing maintenance of devices and for removing devices only when users are ready.
Burkhart also believes the industry could introduce a set of standards that would allow components to be used on multiple devices. Consider batteries as an example. He points out that if all companies in the space used the same battery, it would be easier to replace the battery in one device. Farahani agrees. “A potential solution is to make devices interoperable and allow others to serve them in the long term,” she says.
“This kind of challenge, which we are observing for the first time today, will become more and more common in the future,” Jenka said. Several large companies have invested heavily in brain implant technology, including Blackrock Neurotech and Precision Neuroscience. Also, a search for “brain computer interface” in the online clinical trial registry yields over 150 results. Burckhart believes that about 30 to 35 people have received brain-computer interfaces similar to his.
Leggett has expressed interest in future brain implant trials, but a recent stroke will probably prevent him from participating in other studies, Gilbert said. Since her trial ended, she has tried different drug combinations to manage her seizures. She still misses the implant.
“It was the beginning of a period of mourning for me to finally turn off the device,” she told Gilbert. “Loss – the feeling of losing something precious and precious to me that could never be replaced. It was a part of me.”
