In the 18th century, a biologist named Luigi Galvani made a dead frog twitch using electricity. Scientists have since used that act to make significant progress in the development of neuroprosthetics. A neuroprosthetic is a device that adds to or fills in the input and/or output of the nervous system.
Commercial neuroprosthetics are not new — they have been around for three decades. Most technologies currently explore the same principle, an external device, either a microphone or a video camera that captures the sounds or images and processes them using the results to drive a set of electrodes that stimulate either the auditory or the optic nerve. These devices approximate the naturally occurring output from the ear or the eye.
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Some commonly known implantable devices are Cochlear implants approved by the FDA since 1995), Argus II – a retinal implant (approved in 2013 by the FDA), and deep brain stimulation (DBS), which is the implantation of electrodes within certain areas of the brain to help regulate abnormal impulses. DBS has been used to treat Parkinson’s disease since 1997, dystonia since 2003 and OCD since 2009.
Deep brain stimulation and other neurostimulator technologies that can control and communicate signals to and from artificial body parts (i.e. limbs, eyeballs) are the newest players in the space.
Scientists have been mapping the brain to see how they can treat conditions like Alzheimer’s disease, OCD, Tourette’s syndrome, pain management, epilepsy, essential tremor, urinary and fecal incontinence, depression dystonia, gastroparesis, Parkinson’s disease, and bulimia. Neurostimulator devices that may help paraplegics walk again are expected to reach the market first. The proposed devices beam microvolts of electricity through six surgically installed electrodes to the site of a spinal cord injury. Some experiments with oscillating stimulation have shown results of nerve regeneration after 14 weeks of treatment.
There are even studies being done to improve the functioning and memory space of the brain itself. The neurostimulation devices market (which includes products such as: spinal cord stimulator, deep brain stimulator, sacral nerve stimulator, vagus nerve stimulator, and gastric electric stimulator) is expected to reach $17 billion by 202,4 according to a recent report released by Credence Research.
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The risks of these potentially life-changing technologies, however, are great. Even for the milder treatments discussed above, instances of bleeding in the brain, stroke, infection, breathing problems, nausea, heart problems and seizures have been reported. Then there are the possible side effects of seizure, infection, headache, confusion, stroke, hardware complications, pain and swelling at the implantation site. Almost all of these effects and risks can lead to irreversible adverse events, including death.
The FDA has shared some information as to how these devices are currently being regulated. They’ve categorized most neuroprosthetics under the following classifications:
- Class III: Generally premarket approval;
- Class II: 510(k) (or premarket notification), if the intended use and technology are similar to something already classified;
- De Novo: Devices that are not comparable enough to a product on the market. This generates a new device classification regulation, and will typically (but not always) be Class II;
Clinical data is generally required throughout these three regulatory pathways.
The FDA has formed a new branch called The Center for Devices and Radiological Health (CDRH) Organization Pathway for Neurological and Physical Medicine Regulatory Submissions to oversee brain implantation devices. The agency has also released a guideline for the safety assessment of neurological devices as well as an outline of the nonclinical review considerations here.
Most of the FDA guidelines put forth, so far, have focused on implants that primarily treat diseases like Parkinson’s.
Can the FDA keep up with the emerging innovations in the brain implant space? Although the demand for innovation in this space is burgeoning, there is also extreme opposition from people on the basis of morality and ethics. How the FDA and other governing bodies around the world will choose to move forward with such devices will be interesting to watch in the years to come.
Image: Bigstock
