“The patient should not be forced to explant the device,” says Neeta Farahani, a legal scholar and ethicist at Duke University in North Carolina who has written a book on neuron rights.

“If there is evidence that a brain-computer interface can become part of a person’s personality, then it seems that under no circumstances, except for medical necessity, should we allow the explantation of this BCI without the consent of the human user,” – says Ienka. “If it’s constitutive of a person, then you’re basically removing something constitutive of a person against their will.” Yenka compares it to the forcible removal of organs, which is prohibited by international law.

Mark Cook, a neuroscientist who worked on Leggett’s trial, is sympathetic to the company, which he says was “ahead of its time.” “I get a lot of correspondence about this; a lot of people ask how ungodly it was,” he says. But Cook believes that such results are always possible during medical trials of drugs and devices. He emphasizes that it is important for participants to be fully aware of these possibilities before participating in such trials.

However, Ienka and Gilbert believe that something needs to change. Companies should have insurance that covers maintenance of the devices, such as if volunteers need to keep them after the clinical trial ends. Or perhaps states could step in and provide the necessary funding.

Burkhart has his own suggestions. “These companies have to be responsible for supporting these devices one way or another,” he says. At a minimum, companies should set aside funds to cover the ongoing maintenance of the devices and only remove them when the user is ready, he says.

Burkhart also believes the industry could do with a set of standards that allow components to be used in multiple devices. Take, for example, batteries. It would be easier to replace a battery in a single device if the same batteries were used by all companies in the industry, he notes. Farrakhan agrees. “A potential solution … is to make the devices interoperable so that they can be maintained by others over time,” she says.

“Such challenges, which we are now observing for the first time, will become more and more common in the future,” says Ienka. Several major companies, including Blackrock Neurotech and Precision Neuroscience, are making significant investments in brain implant technology. And a search for “brain-computer interface” in the Online Clinical Trials Registry yields more than 150 results. Burkhart estimates that about 30 to 35 people have received a brain-computer interface like his.

Leggett has expressed interest in future brain implant trials, but her recent stroke will likely make her ineligible for other studies, Gilbert says. Since the trial ended, she has tried different combinations of medications to help manage her seizures. She still misses her implant.

“The final shutdown of the device was the beginning of a period of mourning for me,” she told Gilbert. “Loss is the feeling that I have lost something precious and dear to me that can never be replaced. It was a part of me.”

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