Meet the people behind the technology. There is no glamour or showcase. This is simply the stories of real people living with neurological conditions who have found the use of neurotechnology to impact their lives.
These posts bring the technology to life and feature how this evolving technology can change the lives of average people.
Meet the first person to receive the next generation of deep brain stimulation for Parkinson’s disease. The new technology is skull mounted reducing the surgery time and using a responsive stimulation system. The recharging of the system takes 100 minutes total. The user has the option to split the charging times to fit their weekly routine.
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
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.
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:
Medical technologies, more specifically, neurotechnologies cannot progress without the brave women and men who become the early users. Whether they are participants in a first-in-human clinical trial or they are one of the first early adopters, the people who put themselves forward for the advancement of medical technology are Bionic Pioneers. Much like their fellow pioneers in the discovery of flight or space, there are known and unknown risks. Pioneers are those who accept the personal risks for a broader purpose.
There is a rich history of brain implants into humans. We can go all the way back to 1874 when Robert Bartholow demonstrated that electrical stimulation of specific areas of the brain could result in movements. The first-in-human intracranial electrical stimulation, which would then become deep brain stimulation, was experienced in 1952. It would be difficult to gain the perspective of these early brain implant pioneers. In lieu of this, we turn to the early users of modern-day brain implants. The research is amazing, but even more so are the people who are at the forefront of the latest technology.
The early bionic pioneers are mostly people living with paralysis, epilepsy, Parkinson’s disease, amputation, or other neurological conditions. These are the brave souls to take the first step. The list includes names like Cathy Hutchinson, Jan Scheuermann, Ian Burkhart, Nancey Smith, Nathan Copeland, Buz Chmielewski, and Keven Walgamott to name a few. Today, there are over 160,000 people living with a deep brain stimulation and over 35 people implanted with brain-computer interfaces to control movement. Let’s meet some of these early pioneers.
Early First for Humans
Locked-In Syndrome can be caused by a variety of conditions but it tends to be rare in the overall population. It is a taxing syndrome because people living with this condition are cognitively aware, but lack the physical ability to respond. Conversations become one-word answers of ‘yes’ and ‘no. The ability to communicate is a ticket out of jail. Erik Ramsey, had a brain stem stroke at age 16 and is not unable to move any muscle since then. He became a participant in an early study conducted at Emory University and Georgia Tech. Erik became one of the first people to receive an implanted neurotrophic-cone electrode for the restoration of speech. The implanted system is connected to a computer to synthesize speech from thoughts. Expressed by his father, Eddie, the system “gives Erik the hope of being able to break out of the “Locked-In” condition described by Jean Domonique Bauby in “The Diving Bell and the Butterfly.” The system was one of the earliest implanted brain-computer interfaces.
Several years later, another brain interface headline emerged. Being splashed on the news was not what Ian Burkhart was expecting when he became a participant in the Neurobridge study at The Ohio State University (OSU) and Battelle. That is exactly what happened when the announcement from Battelle highlighted the use of brain-machine interface technology to move a paralyzed man’s hand. Ian was that man. A few years prior, Ian became paralyzed while diving into a wave off the North Carolina coast. In a flash, he was paralyzed; losing the two things he treasured, his active lifestyle and his independence. In 2014, we decided to join a clinical trial for a new brain interface. He endured the 4-hour surgery to implant an electrode array into the motor cortex section of his brain. After many sessions in the laboratory, the computer “learned” Ian’s thought patterns and Ian learned how to communicate with the device. This training elevated to thought patterns for specifically moving his hand. The day came when the research team connected the brain system to a functional electrical stimulation sleeve on Ian’s forearm to control his hand. Just by thought, Ian watched his hand open and close. It was pure excitement. Exceeding his expectations, he then drummed his fingers and later played Guitar Hero using the BCI. “There are people out there dedicating their lives to improve ours,” Ian reflects on the research team. “One day (years from now), I will be able to take it home, but for now I will help move the research forward.”
There are also pioneers who are early adopters of commercial devices. One person that gravitates to the top of the list is Margaret Tuchman who founded The Parkinson’s Alliance. She was, in fact, one of the inspirations of Neurotech Network. I first met her when we were both at the National Institutes of Health campus for a discussion panel. Margaret lived with Parkinson’s disease. When she was diagnosed in the 1980s there was little information available about treatments for PD. She set out to change that through the Alliance and the Parkinson’s Action Network. Nearly two decades after her diagnosis, Ms. Tuchman became one of the first Americans to be implanted with a deep brain stimulation device. She later started DBS4PD.org to help spread information about the device and treatments. While serving on the panel at the NIH, she demonstrated how much it impacted her life. Sitting calmly in a chair on the stage, Margaret turned her DBS off. Almost instantly her severe tremors started and she almost fell to the floor. When she turned the DBS back on, the calmly seated woman returned just as quickly. Until the day she passed away in 2018, Tuchman was a heartfelt advocate and she strongly believed the voice of individuals living with Parkinson’s disease and those who love and care for them must be heard and integrated into the research, policy, and funding process.
Another early adopter of brain interfaces is Mike McKenna who was diagnosed with severe epilepsy. He landed in the ER after driving his van into a canal when he passed out from his first major seizure. From that point forward, Mike’s seizures became more frequent, and they were strong seizures resulting in physical injuries like dislocated joints or broken bones. He was prescribed a slew of medications but nothing seemed to work. Mike found himself jobless, broke, and divorced two years after diagnosis at the Mayo Clinic. His life now revolved around epilepsy. Despite the treatments, Mike was still having grand mal seizures with loss of consciousness and violent muscle contractions. One of his doctors suggested that he participate in a clinical study of the NeuroPace RNS System for refractory focal epilepsy. The RNS neurostimulator is a device that monitors his brain activity 24 hours a day, and recognizes & responds to his unique brain patterns to stop his seizures before they start. It also records Mike’s brain activity, which provides insights that enabled his doctors to optimize his epilepsy care. Mike earned his Bachelor’s and Master’s degrees in social work. He started giving back by working as a Mayo Clinic Social Worker and visiting other people with epilepsy at the Mayo Clinic-Phoenix hospital. He later moved to Portland, Oregon and put his passion to work. Mike is now a Patient Educator for NeuroPace working with others living with epilepsy.
Importance of Options and Preparation
The success stories are always exciting but it’s the failures that also tell the stories. As with any technology, brain interfaces can fail. The recovery from those failures tells the story of resilience as well as the importance of preparations and expectations.
Meet Cathy Hutchinson who had a brain stem stroke at the age of 43, leaving her living with high-level quadriplegia and the inability to speak. In one event, “all my freedom is lost,” she wrote during an interview. Absent of any technology, her communication consisted of eye movements up for ‘yes’ and shaking her head for ‘no’. Without hesitation or fear, Cathy became a participant in the BrainGate project, a consortium between Brown University and Massachusetts General Hospital. Cathy had a small electrode array implanted onto the motor cortex of her brain. When connected to the system, she could adjust environmental controls such as lights, temperature, and music. She could quickly and more naturally communicate with her caregivers, family, and friends. All of this led to her becoming more independent with her daily tasks and opened the door for her to actively interact with the world. Her video and photo were shared around the world when she manipulated a robotic arm to independently drink her beloved cinnamon latte. She did so by using the BrainGate brain interface. Eventually, the signals from her implant started to weaken. In the early use of brain interfaces, this was and still is an issue due to the body’s natural reaction of building scar tissue around the electrode. It came to a point that Cathy could no longer use the brain interface cutting off the communication channel that she once had. She seemed to be prepared for this and accepted the fact that the technology might fail. Working with the research team, they developed an efficient optical gaze communication system for her. Even though she experienced the fluidity of using a BCI, the optical gaze system gave her an alternative tool as she lived out her days.
Jan Scheuermann was also an early BrainGate user but she was working with the team at the University of Pittsburgh. Unlike Cathy, Jan had a degenerative condition called spinal cerebellar degeneration. As she described it, SCD “means that where my brain and spinal cord meet, there is a degeneration of unknown cause.” She was 36 years old when the symptoms surfaced and within a few years she was paralyzed from the neck down. Jan discovered the research team when a girlfriend saw a story about the technology and showed the video to her. Jan thought, “I wish I could do that.” She contacted the research team and became a participant in the BrainGate trial. Her story was featured during a 60-minutes episode titled “Breakthrough: Robotic Limbs Moved by the Mind.” In the video, she demonstrates using her brain interface to manipulate a robotic arm to feed herself a piece of chocolate. When she thought about the future of brain interfaces, Jan wanted the ability to put the device on in the morning, go through a checklist, and then use it all day independently. She imagined that she could use it to brush her teeth, call an elevator or communicate for safety. Jan’s BCI was explanted due to a possible infection. In a conversation only one week following her explant, Jan said that she was comfortable getting the device explanted and she fully understood the risks even before she was implanted. She still experienced the inevitable emotions of missing it. She would miss the technology, the ability, and also the purpose in life as a trial participant. When Jan was first implanted, she welcomed the opportunity and the new purpose in life. When she was explanted, she viewed it as closing a chapter of her life and felt confident that she had the optimism to move forward and the ability to love and be loved for her next chapter.
Whether it is alternative options, mental preparation or conditioning expectations, the technology failures are some of our greatest learning opportunities.
As brain interfaces evolve, they should evolve with the end-user in mind. Understanding the preferences, use cases, and unmet needs of the potential end-user drives the intelligent design of the technology. As Margaret Tuchman would advocate, embedding the voice of the person living with the condition is vitally important. There have been a few studies published about preferences more so for brain-computer/machine interfaces for paralysis. One study by Huggins surveyed 61 people living with ALS about their perspectives for BCI and 84% of the respondents stated that they would accept an electrode cap for recording brain signals. However, the desired features had high requirements including a 90% accuracy rate, simple setup, standby reliability, and a variety of available functions.
In another study led by Collinger, they asked 57 veterans living with paralysis due to spinal cord injury about preference and attitudes toward BCI. In this study, the majority of respondents reported the most useful application of BCI would be to control a functional electrical stimulation device to restore movement. Plus, more than 30% of respondents would consider it “very helpful” to use a BCI to control computers and a wheelchair. They also overwhelmingly wanted to use the device independently and placed a high priority for a non-invasive device but would consider a surgically implanted device.
One other preference study led by Blabe, addressed people living with high levels of paralysis and included non-invasive EEG, minimally invasive ECoG, and surgically implanted intracortical electrodes. Their survey included 285 respondents. The top priority of use was to restore upper extremity function. Preferences were for non-invasive devices and there were related concerns of aesthetic factors, daily maintenance, and potential technician interventions. Finally, in a top ten “wish list” published by Hochberg and Anderson, safety, affordability, and reliability took the topic spots for preferences.
These are only a few studies but more needs to be done. The development and evolution of integrated brain interfaces cannot happen in a laboratory vacuum. As the technology evolves so do the use cases and preferences of the potential users. User-centered design is critical for consumer adoption and satisfaction.
Most of the stories within this feature are from people who are the early pioneers of implanted brain interfaces. Surgically implanted devices bring a level of complexity to the decision-making process for adoption and use. What we are missing from these stories are those of non-invasive device pioneers. If you have a story suggestion, please send a message to Neurotech Network to share.
Computers can predict our preferences directly from our brains.
Pacemakers for the brain can zap away negative thoughts.
These are just a few of the headlines about brain interfaces. With a market size sitting at about $2 billion and a projected growth rate of over 15%, brain interfaces are not only here but trickling into our lives. This is exponentially the case for non-invasive brain interfaces. These are brain interfaces that are not surgically implanted but applied to or near the surface of the skin. They can take many forms such as a wearable, a headset or an immersive space. The longevity and the supporting science of the established modalities give it legs to stand on as an emerging technology. Today, the range of brain interface applications is wide-ranging from military uses to education to market analytics to entertainment. For this installment, we will focus on modalities and use cases for medical and wellness applications. Perhaps the best way to slice the pie is to address modalities and then current and developing use cases.
Think of modalities as technology categories for the delivery of stimulation and/or the sensing of nerve signals from the human body. This is an area where acronyms are of high prevalence like EEG, MEG, tDCS, rTMS, and more. For the average person like me, the acronyms make it easier in conversation. The modalities are best defined by our partners at Neuromodec. With their help, we will explore the modalities of non-invasive brain interfaces.
Electroencephalogram — EEG
EEG has a long history in neurotech scientific discovery. This modality was discovered in the late 1920s and migrated into clinical use during the next two decades. EEG is a technology that detects brain activity. Through the use of small sensing electrodes attached to or placed on the scalp, they pick up electrical activity or impulses. It has been mainly used as a diagnostic tool in medical applications like monitoring seizure activity in people living with epilepsy or understanding sleep patterns. More recently, EEG has been used for brain-computer or machine interfaces and for the sensing aspect of adaptive stimulation therapies like spinal cord stimulation or deep brain stimulation. The traction of this technology shows in the number of commercial entities. We are tracking over 70 products that are either available for sale or near market launch using some form of EEG.
Magnetoencephalography — MEG
A related modality to EEG is the MEG. As the title implies the difference is MEG measures the magnetic fields produced within the brain’s own electrical activity. It is not typically provided in a wearable cap like EEG rather it is a large machine used in radiology clinics. MEG is most commonly used in seizure detection for people living with epilepsy.
Cranial Electrotherapy Stimulation — CES
This stimulation therapy takes the form of a small hand-held device that delivers low level electrical pulses to the brain through sponge electrodes that are placed on either side of the head. The electrical pulses are created by a generator that controls the amplitude and frequency of the pulses. CES was first introduced in the early 1970s but later took hold of the market in the mid-2010s. Mental Health America, a community-based non-profit organization advocating for those with mental illness, suggests clinical applications for a variety of brain conditions like ADHD, insomnia, anxiety, PTSD, depression, addiction, and more.
Transcranial Direct Current Stimulation — tDCS
Much like the CES device, the tDCS device is a portable, hand-held device that delivers low level stimulation pulses to the scalp. It also has a control unit that generates the pulses. That is where the similarities end. tDCS is delivered through electrodes placed on either side of the scalp with one electrode providing the positive current (anode) and the other providing a negative current (cathode). The stimulation then crosses the brain and the stimulation is typically at a fixed level. There are some devices that have regulatory approval for depression, sleep or anxiety. Today, there is a wide array of clinical exploration for the use of tDCS in other areas of mental health such as schizophrenia or addiction as well as other areas of physical health like chronic pain and epilepsy. tDCS is also being applied as a combination therapy with training including physical rehabilitation, memory retention, and athletic training. As a wellness device for mindfulness. There are plenty of DYI kits to build your own device but a word of caution for buyer beware of unregulated stimulation devices to the brain.
Transcranial Alternating Current Stimulation — tACS
Much like its sister, the tDCS device, the tACS modality delivers low levels of electrical current to the brain in a similar fashion. The one difference is the form of the stimulation. For tACS the stimulation is delivered in an oscillating waveform at a specified frequency. The therapy is designed to enhance the brain’s natural rhythms. This modality can also be used as a wellness device outside the purview of the medical regulatory bodies. tACS is under clinical investigation for a variety of brain conditions such as depression, cognition, and motor performance.
Transcranial Magnetic Stimulation — TMS
This modality delivers electrical pulses like those previously described. The difference is how the pulses are generated. The delivery of stimulation is through a magnetic coil that is typically held over an identified area of the head. Magnetic stimulation was first discovered in the late 1800 but it really took hold for clinical use in 1985 when it was used by Barker and colleagues in an application to the motor cortex of the brain. TMS has many alternative forms such as Magnetic Seizure Therapy (MST) or Low-Field Magnetic Stimulation (LFMS) but the more popular alternative is Repetitive Transcranial Magnetic Stimulation or rTMS. This is when the pulses are delivered in a very quick fashion, one after the other or in a repeated pattern. Clinically, this modality has been used to treat depression, OCD and chronic pain and is also being explored for rehabilitation and epilepsy.
High Frequency Focused Ultrasound — FFU
Admittedly, this is not an exclusive modality within brain interfaces. It is, however, an emerging treatment for a variety of conditions of the brain. Traditional ultrasound is widely used as an imaging tool for internal soft tissue-like organs. Combine this imaging ability with high-frequency energy to target deep tissues by sending multiple intersecting beams and that is focused ultrasound. This emerging technology is a non-invasive modality for the treatment of obsessive-compulsive and biopolar disorders. It is also being investigated for autoimmune and inflammatory conditions. The Focused Ultrasound Foundation offers a wealth of information.
This list of modalities can’t possibly be exhaustive. There are other non-invasive brain interfaces that are in development like functional near-infrared spectroscopy (fNIRS), controllable pulse transcranial magnetic stimulation (cTMS), and transcranial static magnetic field stimulation (tSMS). This is a growing area of non-invasive neurotech and it is still in the early stages of widespread adoption.
Modalities are the tools to use but the use cases depict how those tools are used. At Neurotech Network, we typically focus on the conditions that the technologies treat. For this wide area of non-invasive brain interfaces, how the technology is used can have implications on a variety of conditions. Here is a highlight of the most common use cases for non-invasive brain interfaces.
Brain State Analysis
EEG may be the longest standing brain interface modality clinically, but brain analysis is probably the most seasoned of the brain interface use cases. In diagnostics, this technology is applied to understanding the depth of a depressive state, to strengthen new memory formation, to monitor anesthesia levels or to evaluate the quality of sleep. Brain state analyzers are devices used to detect mental states such as consciousness, drowsiness, or emotional distress. The use of EEG has expanded to improve the diagnosis of conditions of the brain and mental health such as Alzheimer’s disease, dementia and depression. They have influenced the ability to properly diagnose or assess conditions, such as epilepsy or brain injury. They also help improve the efficiency of care such as targeted pre-surgical planning and guiding treatment plans for psychological conditions.
Brain Computer or Brain Machine Interfaces — BCI/BMI
This category has attracted the public’s attention. Unlike Brain State Analysis, this is a few frontiers in brain interfaces. BCI/BMI take signals from the brain and convert them to interact with an external source for a particular action. That external source may be a computer or environmental control (BCI) or a mechanical or electrical object (BMI) such as a robotic arm or a stimulating electrode. Using technology to effectively capture neural activity in the brain has catapulted the development of assistive technology applications such as allowing a person with advanced ALS to communicate using a synthesizer. An example of a BMI case is the development of closed-loop systems that can sense action potentials in the brain and then use those signals to activate stimulating electrodes. For instance, a sensing electrode captures signals in the motor cortex of the brain to move a prosthetic limb, and the limb moves. In addition, information from sensors in the prosthetic limb is routed back to the sensory cortex to feel that same limb move. This can be key for amputees using prosthetic limbs and for neural prosthetic applications to move paralyzed limbs.
The area of therapeutics points to the use cases to deliver treatment to the brain for a condition. Most of the use cases in this category apply to mental health and brain disorders. TMS can be used to treat severe depression or obsessive-compulsive disorder. tACS can be used to also treat depression as well as anxiety, insomnia, and even headache conditions. The application of therapeutics is the topic of much of the clinical investigation. Scientists are studying the use of non-invasive brain stimulation in a wide range of conditions that have origins in the brain like Alzheimer’s and Parkinson’s diseases, ALS, addiction, or aphasia.
Cognition & Wellness
Training the brain has been a theme in the wellness arena and active aging. Stimulating brain interfaces have been used to help boost working memory or prepare the brain for learning a new task or information. This is still early in the establishment of scientific evidence but the ability to augment our cognitive state is an appealing proposition for the likes of aspiring athletes or cramming college students. Brain interfaces have also been used to calm the mind into a relaxing or mindfulness state. This use case is not only for the average person’s wellness but can have a meaningful impact on those living with post-traumatic stress or anxiety disorders.
This is an exciting area of research for the application of electrical stimulation and brain signals. Physical rehabilitation has traditionally focused on the mechanics of the body. There is a growing body of scientific evidence to support the need to simultaneously rehabilitate the body and the brain. One example is cortical stimulation applications for traumatic brain injuries and stroke survivors. Here the stimulation is applied to the damaged sections of the brain to excite neural activity to ‘retrain’ the brain neurons in a phenomenon known as neural plasticity. The brain is stimulated to become more engaged in physical activity. This has the potential to change the way we rehabilitate the body after damage to the brain. Brain stimulation can also have the potential to enhance the brain-body connection for paralyzing conditions like multiple sclerosis and spinal cord injury as well as for more common surgical procedures like hip and knee replacements.
These are just some of the use cases for non-invasive brain interfaces. There are more use cases in the pipeline of development and even more are in the ideation stage. With over 70 commercial entities (that we are tracking) in this field, there are surely more use cases to come as technology improves and we evolve with it.
Now that we have explored the implanted and non-invasive aspects of brain interfaces, our next part in this series will feature meeting the people. We will highlight some of the early adopters of brain interfaces to gain their perspectives.
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.
Rapidly evolving medical technologies in the specialized field of neurotechnology are changing the way to diagnose and to treat the condition of epilepsy and seizure management. Last year, Neurotech Network provided a overview of the available neurotechnologies such as EEG, vagus nerve stimulation and responsive neural stimulation. You may find this overview titled “ Better tools and treatments emerging for Epilepsy” here.
We are providing an update of technologies that have been commercialized for access and emerging technologies to revolutionize treatments. Here is our annual highlight:
Electroencephalogram (EEG) is a long-standing technology in the field of epilepsy diagnosis. They are typically found in clinical or hospital settings but the latest technology has moved the EEG headset from the clinic to the home environment. Neuroelectrics offers their Enobio device as a portable and high-resolution EEG headset. Also in the category of EEG, Brain Scientific was the first company to offer a disposable EEG cap also to be used as a portable diagnostic tool in areas such as sports fields, nursing homes, and rural settings.
Brain analysis is not just in the form of external EEG caps. In the last year, we have seen an evolution of the cortical electrode. These are soft and flexible electrodes that are used intraoperatively to target areas of the brain for analysis or treatment. Emerging companies like INBRAIN, Neurosoft Bioelectronics, WISE, NeuroOne, and Neuraura are all competing in the area of brain-sensing and analysis.
On the topic of brain implants, a new venture, Cadence Neuroscience, is developing a generation of brain implants to manage seizures associated with epilepsy. In their research at the Mayo Clinic, their system includes a ‘trial’ period. Clinical study participants will endure an EEG monitoring phase for system optimization. If they choose to continue, then they can receive an implanted neurostimulator and electrodes for a targeted continuous electrical stimulation therapy.
In the arena of adaptive stimulation and brain implants, industry pioneer, Neuropace, recently announced a potential indication expansion of their RNS device for those living with drug-resistant idiopathic generalized epilepsy. The U.S. FDA recently approved the use of brain-responsive neuromodulation in a pivotal clinical trial, the NAUTILUS study, for the treatment of IGE. Enrollment is expected to begin in 2022.
There is also a growing segment of non-surgical modalities, Neuroelectrics has a non-invasive headset under investigation for the treatment of epilepsy. Their Starstim device offers transcranial electrical stimulation coupled with EEG for a targeted treatment approach. This is still in clinical trials but may be used for expanded use cases such as physical rehabilitation and addictive disorders rehabilitation.
Another external device is under investigation is vagus nerve stimulation. VNS has been approved for epilepsy for decades but as an implanted device. More recently, gammaCore, a non-invasive hand-held VNS device as received CE Mark approval in the European Union as adjunctive therapy for seizures. It is currently under investigation in the U.S. for the treatment of epilepsy.
Finally, a new wearable device may offer a promising new aspect toward seizure detection. A research team at the Mayo Clinic led by Dr. Mona Nasseri is developing a wrist-worn device used to forecast the onset of a seizure within minutes to hours prior to the occurrence. The investigational device uses EEG and recurrent neural network algorithms to provide a prediction tool for people living with epilepsy. The study results were recently published in the November 2021 issue of Scientific Reports.
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:
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.
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.
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.”
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