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Brain Interfaces: The Future is Ours

In this Brain Interfaces series we covered the early technology developers, the array of use cases, surgically implanted brain interface devices, wearable technologies, and the amazing bionic pioneers. The road to where we are today is paved with great successes and agonizing failures, but that is par for the course. There are technologies that are making a societal impact today and those that have just begun to blossom into the next generation of brain interfaces.

None of the development and advancement in brain interface technology could have occurred without the early investments. The vision of those who supported the early efforts made the compelling case for funding support. These are not the swanky Wall Street hedge funds, the enterprising venture capitalists, or corporate investors. This is a reference to the funding agencies. That’s right, the government funders. Often viewed as agency bureaucrats, the funding agencies make the riskier investments in new and novel technologies; ones that Wall Street would never touch. They also tend to be the forgotten supporters.

Early Financial Support

This is the case in brain interfaces. In the United States, funding agencies like the National Science Foundation, the National Institutes of Health, Veterans Administration and DARPA (Defense Advanced Research Projects Agencies) funded the foundational research for the development of many brain interface modalities. As with any scientific endeavor, the early investments led to enterprising technologies. The most well-known and significant financial support came in the form of the Brain Research through Advancing Innovative Neurotechnologies or BRAIN Initiative. This is the Human Genome Project of our time. Announced at the U.S. White House in 2013, the focus was aimed at revolutionizing our understanding of the human brain leading to new ways to treat, cure and even prevent brain disorders. The vision was and still is to expand opportunities to explore how the brain enables the human body to record, process, utilize, store and retrieve information at an incredible speed. The initiative launched as a collaboration between 14 NIH Institutes and centers as well as other aforementioned agencies. As of 2019, the NIH alone has contributed $1.45 billion to the Initiative. This effort has now grown around the world and in 2018, the International Brain Initiative was launched as a collaboration of programs around the world in the scientific effort to better understand the human brain.

There were also early visionaries at DARPA which launched smaller programs in the early 2000s. One notable effort was BioFutures. In 2005, the small program brought together biology, electronics and information sciences to develop a new human-computer interface with seed funding of $12 million. That seems like a lot of money but the findings from that early investment evolved into programs leading to human trials like the Revolutionizing Prosthetics launched in 2006. RE-NET (Reliable Neural-Interface Technology) launched in 2010. Restorative Encoding Memory Integration Neural Devices (REMIND), SUBNETS (Systems-Based Neurotechnology for Emerging Therapies) and Restoring Active Memory (RAM) programs that began in 2013. Follow-on DARPA programs continue to expand development and investments with many having parallel goals to translate technologies to impact society.

These are only a few of the early investments that sparked the development of brain interfaces. Today, we are now experiencing the translational efforts and many of the technologies highlighted in this series were supported by the early investments. Those technologies and the ones that will follow have been de-risked to aid in the translational efforts to appeal to commercial investors who also take risks to push the technology from laboratories into treatments, products, and diagnostics that can be used in the clinic or at-home. To do so, commercial ventures need to realize the market forces like therapeutic efficacy, cost-effectiveness, real-world outcomes, and clinical or consumer adoption. This is where we begin to realize the societal impact.

“Those who do not remember the past are condemned to repeat it.”

— George Santayana

Ethical considerations

Today, we are living through the perils and societal complications of social media. We do tend to have short-term memories. With that in mind if we can learn from the mistakes of today then we are less probable to make them again in the future. Brain interfaces are in their market infancy. They are where social media was in the 1990s. Back then social media was considered only a communication alternative. Today it impacts so many facets of our society. The brain interfaces of today and tomorrow have the potential to do the same.

There are several efforts around the world to look at the various potential aspects of neurotechnology that can impact our lives. Today, the main focus is in the medical realm but it has begun and will continue to expand into other areas like entertainment, arts, sports, legal, wellness and more. Even in the medical field there are difficult questions to address like articulating the potential risks and long-term consequences of technical failures, assessing the viable options for obsolete implanted devices, or securing privacy and sensitive personal data against malevolent programming.

One of the published guidance on ethics in neurotechnology was made available in 2019 by the Organization for Economic Co-operation and Development or OECD. Through a five-year process, this provided the first international standard in neurotech titled Recommendation on Responsible Innovation in Neurotechnology. The guidance addresses areas like safety, inclusivity, collaborations, and cultures of stewardship to name a few. Another international effort has been led by IEEE Brain. Here they are building a neuroethics framework to address not only the ethical issues but also those of legal, social and cultural influences. Their approach addresses the implication within a variety of application domains such as the most common uses of medical or wellness applications to others that are not so common (yet) such as work and employment, sports competition, and entertainment.

Despite the international collaborative efforts, some countries are taking the approach to address ethical implications now as a human rights issue. Chile is the first country in the world to adopt a bill of rights for its citizens in the form of “neurorights.” In late 2021, the Chilean National Congress passed a constitutional amendment and it was signed into law by the President of Chile. This bill provides protections which subject all neurotech devices in Chile to the same regulations as medical devices. For context, in some countries, if a device is not making a medical claim and is sold as a wellness device, it typically does not require regulatory review. The new amendment in Chile provides protections of neural data banning the buying and selling of this data. It basically considers human neural data to be equivalent to a human organ.

Even with these international and specific country neuroethical efforts there are still many unanswered questions. Human augmentation is one that comes to mind. Performance enhancement and social justice are others. The topic of ethics and neurotechnology still has many iterations of development particularly as neurotech emerges into other markets outside of the medical domain.

Future Directions

The future is bright for this once small and emerging field. The pace of technological advancement is accelerating to transform as we learn about the human experience. The introduction of cortical plasticity refers to the adaption or modification of neural connectivity in the human nervous system, particularly the brain. This phenomenon opens the door for recovery from injury or degeneration due to disease whereas the neural circuits reorganize themselves. New rehabilitation paradigms can harness neuroplasticity leading to the recovery of function. Another area of development is sensory feedback or closed-loop systems. Also referred to as adaptive systems, technology has the ability to sense a neural activity and either deliver a notice to the user or change the response based on this feedback. This allows neurotech systems to learn the behavior of the user and customize the treatment. One more area of technical development is the emergence of minimally invasive or non-invasive devices. New modalities like focused ultrasound, injectables, and optogenetics can lead to targeted treatments or therapies without long surgical procedures. If and when they are applied in clinical practice, these new modalities offer promise to lower costs, improve the accessibility, and ease the user burden of neurotech devices.

The growth of neurotechnology has traditionally been in the medical application domain. This is justified by the early investments for the early versions and use cases of the technology. One of the first expansions from this traditional space was into wellness. This includes both emotional and physical well-being. Think about areas like relaxation, stress reduction, attention enhancement and sleep productivity. This domain expansion is not as controversial as some others such as workplace or employment applications. Arguably, some neurotech devices can be used to monitor human behavior, measure productivity or evaluate alertness. Absent of protections this has the potential to fuel workplace conflicts and blur the lines of privacy. On a lighter note, another expanding domain for neurotech is in entertainment. Say goodbye to those 3D glasses. Neurotech can be an entertainment wearable in the form of virtual reality, EEG gaming headsets, brain-to-brain artistic expression or biometric feedback. Innovations in this field have the potential to transform visual, audio, and event movement artistic expression and artistic experiences.

This brain interface series was intended to provide an overview of brain interface technology from the early stages through the modern-day pioneers. If you missed the earlier installments, please access them below or through our website. Most recently, the Milken Institute published the Neurotechnology: A Giving Smarter Guide. It provides a good overview of the industry, research landscape and the opportunities to help move it forward in the future.

The Brain Interfaces was a five-part series. Early commentaries are:

More information about neurotech devices for various neurological conditions and other network resources may be found on the Neurotech Network website. The entire series can be found on Medium.

Brain Interface Series: What is Implanted Embodiment?

The word “embodiment” can conjure up an array of thoughts and images. For a patent, embodiment describes the use, production, expression, or practice of an invention. In the world of art, embodiment drives the meaning of the perception of emotion. Both are true in their own context. What do you imagine when you think of brain interface embodiment?

This takes me back two decades to my first Neural Interfaces meeting on the campus of the National Institutes of Health in Bethesda, Maryland. As part of a panel of neurotechnology users, I and other panelists were taking questions from an audience of scientific investigators. Dr. Joe Schulman of the Alfred E. Mann Foundation posed a question like this:

“If we cut open your skull, implanted an array into your motor cortex, wirelessly connected it to a prosthetic, and then you can move by thought, would you get it?”

My gut reaction took over and I blurted out this response:

Read More

Brain Interfaces Series: Has the evolution only just begun?

Is it just hype or are brain interfaces here to stay? Are we at an inflection point? There has been an explosion of non-invasive modalities for the brain while at the same time a thrust to commercialize brain implant technology. At this point, it seems donning a ball-cap or helmet to read signals from the brain seems more accepting than a surgical implant. On another note, a brain implant to treat a chronic medical condition seems more acceptable while the idea of a brain implant to augment human performance leads to discussions toward fears of the unknown or potential unethical practices. Overall, are brian interfaces the right thing to do? Setting aside the technical and scientific jargon, our focus is to probe this area of neurotechnology. In this series, we will explore the origins of brain interfaces, embodiment options, the bionic pioneers of our time, and where we are headed in the future. If there is a specific area that you would like to see covered, post a comment and we will add it.

Brain Computer, Brain Machine or just Brain Interfaces

Human and machine interfaces have been evolving for several decades. The heart pacemaker has advanced tremendously since its first-in-human implant in 1958. Today, they seem to be commonplace with new bells and whistles like wireless communications, rechargeable batteries, and remote monitoring. Still, the heart pacemaker seems to be in a different class since it is an intervention for a muscular organ rather than the complex neural network of the brain.

Read More Here.

Richdeep, Sandra & Jon

Early experiences with Spinal Cord Stimulation for Spinal Cord Injuries

Meet Richdeep, Sandra and Jon who participated in a panel discussion about their experiences as clinical trial participants using spinal cord stimulation for the treatment of spinal cord injuries. The discussion is moderated by Barry Munro with the Canadian Spinal Research Organization and John Chernesky with the Praxis Institute. Topics explored include participant expectations, benefits of involvement, and challenges to participate.

Learn more about neurotechnologies for spinal cord injury with our neurotech directory.

Danielle B.

Non-invasive stimulation to control Migraine Headaches

Stress from work and strained relationships took a toll on Danielle as her migraine headaches became more severe and more frequent. This physically active young woman who loves to cook, bake, and work out found herself struggling as her migraines started to disrupt every aspect of her life. 

Migraine headaches tend to be a hereditary condition, but for Danielle, there are no known family members with the condition. Not an official causal diagnosis, Danielle started having migraine headaches after she was in a car accident at the age of 19. As she turned into her 20s, the condition became worse. Despite taking prescription and over-the-counter medications, she still endured days, even weeks with debilitating pain. By the time she was in her 30s, her migraine headaches were at a peak where she was having rebound headaches and became resistant to medications.  She went to countless neurologists but consistently walked away feeling like they weren’t listening to her. “I couldn’t find a physician who would take the time to see my circumstances,” she says. “to really get to the bottom of it.”

Prior to the pandemic, she was working in a fast-paced healthcare environment as an occupational therapist and was pushing herself to succeed. That internal drive to succeed left her with severe migraine headaches landing her in the hospital. The standard treatment of prescription medications did not work for her and the side effects were not healthy. She tried other alternatives like physical therapy, injections or creams but none had a significant change to her migraines. Pushed to the point where she was no longer able to work, Danielle found herself bed bound from severe headaches and living on disability. 

Once the COVID-19 pandemic took over the world headlines, her condition was uncontrollable and she decided to quit all the medications cold turkey. She was taking so many medications and the side effects were unbearable. That process was not easy. “It was the worst.” She remembers, “I never felt so much pain before.” It was a friend who recommended a doctor based in Cleveland, OH. She made an appointment and traveled there. During their visit, the doctor recognized that Danielle was desperately trying to find a solution. He was the first to recommend a new, non-invasive, drug-free remote electrical stimulation (REN) device. The REN device is worn on the arm. It delivers electrical stimulation to the C and Aδ fibers in the peripheral nerves activating a brainstem-mediated pain control pathway to block the pain signal. This “conditioned pain modulation” method is believed to “switch off” the catalyst of migraine attacks in the brain. 

Interested in finding other solutions that would quell her migraine episodes, Danielle ordered the device. She was a little hesitant at first but after trying so many other failed therapies she was excited to try a potential solution. Upon her first attempt, she had mediocre results. During the second treatment session, she drastically increased the intensity with lackluster results. Turning to a Facebook group, there was one person who responded to her question about the REN therapy who had poor results as well. 

A customer service agent from the company explained to Danielle that the highest intensity is not always the most effective setting. They recommended Danielle to turn down the intensity and then try the device again. At that point, she started feeling the benefits, so much so that Danielle was using the device multiple times per day. After using the REN therapy for one year, she uses the device only when she has a migraine attack. Today, Danielle now works part-time at a special needs school and she is taking classes to earn her Bachelor’s degree in Education. 

Chronic pain conditions are seldom a one treatment fix. Many pain experts recommend a combination of methods and modalities to help people take control of their chronic pain. For Danielle, she now uses a combination of biofeedback, acetaminophen, and the REN therapy to control her migraine headache condition. She also found that using the REN therapy while in a dark, quiet room yields the best results for her.  The advice she offers to others living with migraine headaches is to search every avenue for the right treatments. Pain management is an individualized endeavor.  “Don’t get discouraged. There are always options.”

Learn more about neurotechnologies for migraine and cluster headaches through our neurotech directory.

Jill W.

Percutaneous Surface Stimulation for Chronic Pain

There are so many options for treating chronic pain but finding the right solution and getting the right diagnosis is like trying to find a needle in a haystack. Jill is no exception. Living in rural Wisconsin, she lives a very active lifestyle with her husband and three children, enjoying the outdoors and being small business owners. But when her pain started to interfere with her lifestyle, something had to change. 

Jill remembers always having aches and pains, even when she was young and raising her children. The chronic pain in her lower back transformed into becoming systemic and she could no longer have a direct cause for the pain such as lifting a child the wrong way or twisting too much while gardening. The pain was constant and she wanted to know why and how to fix it. While in her 30’s she was diagnosed with fibromyalgia, but she as not satisfied with that labeling of her pain. 

Not having a clear treatment guideline, she began to try various options.  First was pharmaceutical.  She tried a few but did not like the way she felt and truly opposed taking medications over a long period of time. She then began to see a chiropractor, but that did not help either. She then tried an osteopathy and then physical therapy but neither was effective. Jill’s back pain persisted. She then opted for some cortisone injections into her back. It helped temporarily, but the nagging pain in her lower back would come back before she could schedule another injection. Not finding a solution in the medical field, Jill started to look elsewhere. She tried gadgets sold on-line and over broadcast television. She felt like she was “chasing rainbows” and spending a lot of money trying to find a treatment.

Jill was on the internet searching, hunting for a solution. She found the manufacturer of a percutaneous electrical nerve stimulation (PENS) device. While speaking to the company representative, she was cautious at first, even a little skeptical. She was familiar with transcutaneous electrical nerve stimulation (TENS) but not PENS.  TENS units use pulsed low frequency electrical current delivered from a small unit through two electrodes placed on the surface of the skin.  The electrodes are small pads with a sticky gel to help conduct the electrical activity from the unit through the surface of the skin.  A PENS device sends alternating high frequency current signals from the unit through deep tissue electrodes also placed on the surface of the skin.  The PENS electrodes are different from TENS electrodes because they have microscopic needle-like probes that penetrate the surface of the skin to deliver the current deep into the tissue. The deep tissue treatments tend to have a long lasting effect. Clinical trials have also demonstrated not only a reduction in pain, but improved range of motion and reduced muscle spasms. 

Jill got a prescription for the device from her doctor and ordered the device for home delivery. Upon arrival, Jill set up the small, pre-programmed, portable device and placed the electrodes on her lower back. Trying the device for the first time, she could feel the electrical pulses on her skin but it was not uncomfortable like an electric shock. Instead, it felt more soothing like a massage. More importantly, the pain relief was almost immediate. There was no waiting for a medication or taking time to drive to an appointment. This small, handheld device was giving Jill relief from the pain that has been haunting her for years. 

Over time, she has found her body to be flexible again and her movements more fluid. After playing volleyball with her son, her shoulder was bothering her the next day. She placed the electrodes on her shoulder area and with one treatment the shoulder pain extinguished. With consistent use, Jill has found the intensity of her daily lower back pain has decreased and confidence in her motions is back. “I just don’t hurt any more,” she declared.

Not all chronic pain is the same and that warrants the many options that people have for treating it. The key is to try the variety of options to find the right solution. Learn more about neurotechnologies for pain management with our neurotech directory.

Jim J.

Paralysis & Restoration of Hand Function

Pioneers are not made; they are missioned. Conventional thinking points to scientists, engineers, and entrepreneurs as the sources of innovation. They definitely have a hand in the process, but we often forget the influence that the end-user, or consumer, has on the technology innovation process. Jim was one of those pioneers that shaped generations to come in neural prosthetics. Jim was an average guy, born and raised in Northeastern Ohio. He graduated from the University of Akron with a mechanical engineering degree and went to work for Firestone in Ohio. He had a loving family and married the love of his life. He had his beloved hobbies like playing pool, scuba diving and working on his green Chevy Camaro. The oldest of six, Jim spent much of his free time with his family and his younger siblings.

One summer afternoon, Jim dove into the lake to cool off on a hot summer day after helping to paint his sister’s house. He hit a shallow spot, compressing his head into his spine and paralyzed him immediately. Jim couldn’t move and couldn’t feel a thing. Being the first on the scene, his sister, Judy, pulled her brother to the surface in a panic to save him. “I can’t feel a thing,” Jim said. From that point on, Jim entered the world as a high quadriplegic, unable to move his four limbs, care for himself, or create the mechanical drawings that he loved to do. Life would be forever different. Jim later became one of the fire people to try an experimental implanted neural prosthesis to restore function in his arms and arms….this was back in the 1980s.

Remember: We are standing on the shoulders of pioneers like Jim.

Learn more about neurotech applications for spinal cord injury.

Read more of Jim’s story in the book, Bionic Pioneers. Proceeds go toward Neurotech Network.