FDA finalizes 'leapfrog' guidance on use of thought-controlled tech in paralysis patients, amputees

Digital X-ray brain on blue background neurons
The FDA document outlines recommended clinical study practices for implanted devices that are controlled by brain activity to improve accessibility for people with severe disabilities. (sdecoret/iStock/Getty Images Plus)

We may not yet live in a “Matrix”-like dystopian world in which our brains are used to control the technology around us (and vice versa), but the FDA, for one, is already prepared for that future that, at times, seems inevitable.

The agency issued the final version of its guidance on brain-computer interface technology, outlining best practices for clinical and nonclinical testing of implanted devices that use brain activity to restore motor and sensory capabilities in patients with paralysis or amputation.

The initial draft of the document was published in 2019, when the FDA also formed a group of 15 experts to keep an eye on advancements in the futuristic realm of thought-controlled technology.

The draft guidance offered recommendations about these devices’ electrical and electromagnetic safety needs, plus their long-term biocompatibility with users’ blood, cerebrospinal fluid and nerve tissue. It also advised technology developers on using nonclinical testing to mitigate any potential risks before beginning carefully designed clinical studies.

RELATED: FDA drafts ‘leapfrog’ guidance on brain-computer interface tech

The final version adds a section on “human factors,” referring to the potential harm that device users can face if they don’t fully understand or improperly interpret information from the device.

The FDA recommends that device makers take these risks into consideration throughout the design process, consistently gaming out harmful situations that could arise based on the characteristics of a device’s intended users and the environments in which they’d use the technology.

The new guidance also beefs up the original document’s recommendation that clinical studies of brain-powered devices take place in home environments to paint a more realistic picture of the devices’ actual use cases. The agency suggests that, if a caregiver is required to help a patient use a brain-computer interface, a clinical trial should make sure to assess caregiver performance alongside device performance and also include a robust training program for both caregivers and patients.

Finally, the FDA also asks any developers of technology outside the document’s exact scope—that is, “implanted BCI devices that interface with the nervous system to restore motor and/or sensory capabilities in patients with paralysis or amputation”—to seek FDA feedback before applying for clearance or approval.

RELATED: FDA approves wireless brace that uses brainwaves to improve hand function in stroke patients

Though the guidance is classified as a “leapfrog” document offering recommendations for a still-emerging class of devices, plenty of brain-computer interfaces are already in development, and a couple have already received regulatory green lights.

Just last month, the FDA issued market authorization to Neurolutions’ IpsiHand Upper Extremity Rehabilitation System. The device uses an electrode-covered headpiece to record brain activity and send it to a tablet, which then wirelessly sends a signal to move a hand brace, helping stroke patients relearn how to grasp objects.

And, of course, any update on brain-computer interfaces would be remiss not to mention Neuralink, the mind-reading chip maker led by Elon Musk, who, incidentally, is fairly confident that we are in fact already living in the Matrix. Neuralink’s device, which received an FDA breakthrough designation last summer, is robotically stitched onto the brain and will ultimately be able to address musculoskeletal and neurological problems, as well as track movement and stream music, “like a Fitbit in your skull,” per Musk.

However, as Musk explained in a company livestream last July, it may take many years before those capabilities are actually scientifically possible—and maybe longer still if he keeps taking time off to host “Saturday Night Live.”