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 TARDIS

TARDIS - team: Claire Wang, Neel Redkar, Charles Duong, and Andrew Gao

Technical Report        1

Technical Summary        1

Need Statement        3

Background Technology        4

Concept Details        5

Business Prospectus        6

Business Description        6

Market Analysis        7

Competitive Analysis        8

Cost        9

Funding Sources        11

TARDIS Supplemental        13

References        13

Figures and Additional Photos        14

Technical Report

Technical Summary

More than 100 million Americans are not getting enough sleep, or more importantly, high quality sleep. Irregularity in duration and consistency of sleep has been proven by the American Diabetes Association to increase up to 27% the risk of obesity, high cholesterol, high blood pressure, cancer, dementia, and other health problems (Huang 19).

TARDIS, transcranial applicable repeating deep interchanging stimulation, relies on the work of hundreds of scientists over the course of a century. In summary, the general schematic of TARDIS has two modules. First, there is the data collecting portion, where an EEG (electroencephalogram) collects brain wave and electrophysiological data from the patient and sends it off to a small computing chip for processing. This wave data is elaborated more in our background information, but in summary, there are a few different types of waves that it records, such as gamma, delta, etc. That brings us to the second part, the processing. Here, we analyze how well the patient is functioning in their chosen state, be it relaxation or focus. If a patient is attempting to sit back and comfortably meditate, TARDIS can reasonably expect that the brain wave frequency should not surpass the levels of alpha waves, approximately 12.5 hertz. If TARDIS detects high activity during expected relaxing times, it’ll first send the user a report through the app notifying them of their possible distraction or asking if they want to end the session. The user can then choose to ask TARDIS to help entrain their mind to relax. Here, some of the attached electrodes switch their function to alter the brain wave activity of the user. This is called entrainment and can result in long-term positive effects even without the TARDIS-cap on.

We want to focus on a few things to make TARDIS as successful as possible. First, we want it to be simple and safe to use. By making a hat that’s made to avoid tangled wires or accidental zaps, we make it unintrusive to have on (and even stylish!). Additionally, the fundamental concept of TARDIS is not at all intrusive, meaning there is no risk of damage, and any discomfort is easily mitigated by simply taking off the hat. It won’t be a hefty cap like those of the Brainiac in the DC comics and certainly will only alter brain waves based on data and evidence from widely received papers.

Secondly, we want TARDIS to be accessible. Many people of today need such a product to assist them in dealing with neurological conditions such as sleep disorders. However, existing medical technologies and infrastructure can be extremely expensive, leaving many unable to access the help they need. We pursued our goal of making TARDIS accessible by constantly keeping in mind how we can lower costs.

Finally, we want TARDIS to be effective. It is vital that we do not sacrifice accuracy and effectiveness for accessibility. In order to do this, we will thoroughly test our design to make sure that it is up to or even better than our less accessible and less ethical competitors. Every aspect of neurological technology in our product has been proven many times to be effective and safe. Most notably, research by Hanslmayr and Herrmann shows the reliability of EEG readings, and Park proved that tDCS is an effective method of neuromodulation. In summary, our technology is backed up by many researchers but we are yet to apply our technology to a final prototype.

Need Statement

According to the WHO, up to 1 billion people (nearly one in six of the population) have suffered from neurological disorders. On top of that, the WHO estimates that one in four people in the world will be affected by mental health or neurological disorders at some point in their lives. These disorders include Alzheimer’s, Parkinson’s, and epilepsy. Many bacterial, viral, enteroviruses, fungal, and parasitic infections can affect the nervous system where neurological symptoms may occur due to the infection itself or an immune response. We tackle this problem by assisting people with mental health disorders related to anxiety and attention, especially for patients whose disorders have proven to be resistant to many drug treatments. By utilizing transcranial stimulation through EEG electrodes, we can aid, for example, a person unable to sleep by detecting when brain waves reach low frequencies during waking periods and gently altering it.

On top of neurological disorders, we address mental health conditions (we recognize that certain sources may draw distinctions between “mental health conditions” and “mental illnesses”, but we intentionally use them interchangeably). According to the National Alliance on Mental Illness (NAMI), a mental illness can be defined as, “a condition that affects a person's thinking, feeling, behavior or mood”. Such conditions lead to a deep impact on day-to-day life and may affect the ability to relate to others. It is estimated that 1 in 5 US adults experience mental illness each year with 1 in 20 US adults experiencing a serious mental illness each year. On top of that, 1 in 6 US youth (aged 6-17) experience a mental health disorder each year. 50% of all lifetime mental illnesses begin by the age of 14 and 75% begin by the age of 24.

TARDIS helps those with mental health issues ranging from anxiety, ADHD, PTSD, and depression. For example, if a student is diagnosed with ADHD and has trouble focusing in school and getting along with others, we can help by improving his or her focus in school and mitigate symptoms of attention disorders, helping children perform better in school and social environments. To give users more control, TARDIS provides the user with feedback through the app as well as allow the user to make specific edits to stimulation, similar to current self-piloting screen time apps. TARDIS is designed to non-invasively give users the benefits an implant or stimulator might give them without the high cost, ethical implications, and risk involved.

One of the most unique parts of this project is that while it seems very high-tech or complex, it can really be used by anyone, even if they don’t have knowledge in neuroscience or electronics. Electrodes are increasingly becoming popular as tools of understanding more about our brain activity, even for those who may not be doctors or neuroscience specialists. Given their popularity (and commercial success in certain products), there are very low cost electrodes that enable TARDIS to be accessible to a much wider audience.

There is a widespread need for people to be more productive and have higher quality of presence in their daily lives. Interestingly, there is so much potential for advances in neurotech, and yet we have only such few commercial products that are in such a field.

Background Technology

Brain waves, also known as neural oscillations, are vital to our technology. EEG, the measurement and stimulation of brain waves, has its roots as far back as 1929, when a German scientist named Hans Berger found electrical feedback whenever he connected the wires of a patient to a galvanometer.

There are 5 main “themes”, or patterns, of brain waves that mean different states of consciousness, and we can see in the figure below. Each is delineated by a specific frequency.

In the human brain, oscillations occur during neural processes that are relevant for memory and focus. There have been many studies correlating memory processes to specific oscillatory frequencies (Buzsaki 2006, Rhythms of the Brain). Even better, there have been many recent studies that go beyond mere correlations and have shown a causal relationship between oscillations and alterations of memory and attention functions (Hermann 16). According to Hermann, there have been many studies showing correlations, but the only way to prove causation is by directly altering brain signals, and they do exactly that.

There are certain research teams doing similar research. For example, the LONN lab at UCLA is doing similar research on PTSD treatments, but they utilize VR and deep-brain implants (that require surgical implantation) to collect data. Additionally, the Cognition and Oscillations Lab at the University of Birmingham is doing research on additional applications of EEG. This is beneficial because we can utilize their publications and collected data to provide a scientific basis for TARDIS.

Concept Details

We’ve already made a lot of progress on the first module of TARDIS, data collection. WIth our EEG, which was extremely easy to put together and is unintrusive, we were able to collect lots of data comparing brain wave activity during different levels of focus. When we wanted to relax and go to sleep, there was a strong prevalence of delta waves. During class or times of high focus, there was a high prevalence of beta waves. Even more surprisingly, we could even find a statistically significant difference between true focus and just wakefulness. When watching a video or eating, brain activity was only at alpha wave frequencies, which meant that while we were adequately awake, there was no level of deep focus.

Finally, to describe the product in detail, we envision a two layered hat with electrodes wedged between the two layers. The user puts on the hat and adjusts it to make sure electrodes are able to make contact with the scalp. They can then open up the app and choose their goal or task. For example, if they want to focus on studying for an upcoming exam, they can choose to have TARDIS monitor their focus levels and gently nudge them (with a notification or even with neuromodulation) when it seems they’ve lost focus.

So what happens after the user chooses their options? The phone is paired to our computing board through bluetooth and sends a signal to the receiver. There, there is a continuous exchange of data, with the board monitoring brain waves, processing the dominant wave type and sending the frequency and type off to the phone. The board also does analysis of the variations in spindles and oscillations to detect possible anomalies or “low-quality” attentiveness using a pre-trained neural network and fourier transform. All this data is sent off to the phone, which matches the received data with the user’s settings.

Here is the magical part! The phone sends the user a ping, asking them if they’re daydreaming or actually just watching a youtube video. Nothing makes you focus better than guilt! Here, the user can choose for TARDIS to do its magic. If they choose to do so, the tDCS electrodes on the two sides of the cap (we only need two in that case) activate and the user will be gently nudged towards increased focus, sleep, or anything in between!

The mobile app, of course, has a lot of potential for additional benefit. We foresee integrations of games and tests of memory and focus to train the neural network to be more specific for the user and to analyze the brain patterns of the user. There is ample evidence to show EEG readings are strongly correlated to memory performance (MacDonald 19, Suthana 18).

Business Prospectus

Business Description

In a nutshell, TARDIS is a response to the widespread pandemic of demotivation and disinterest of today. By enhancing every different aspect of the day to be higher-quality, we can impact the lives of people of all ages and paths.

TARDIS, transcranial applicable repeating deep interchanging stimulation, is an effective, accessible, and ethical solution to neurological disorders and mental health conditions that uses an EEG (electroencephalogram) and a small processing chip to collect data on brain waves and process it in order to give feedback and with consent, gently alters brain waves to assist in specific functions such as focus and sleep.

Our business is focused on the distribution and licensing of TARDIS, a modulating and analyzing brain “cap” that helps users focus, sleep, meditate, learn, and live better. Through selling either just our computing chip or the entire product, we allow users greater freedom to choose what they would like to do. In addition to just selling this product, we hope to increase students’ interest in neuroscience by partnering with schools and organizations to teach them to build an EEG and understand how the hardware works.

We strive to assist in solving neurological disorders and mental health conditions through our accessible and effective product. In phase 2 (described more in detail below) we plan to work with medical professionals to learn exactly how we can best benefit those of different disorders and create products adapted to each specific need.

The three main facets of TARDIS is affordability, noninvasiveness, and effectiveness. By simplifying much of the structure and design, we make our product affordable to those who need it most: students and those at a disadvantage due to their neurological state. Since TARDIS is entirely extracranial, meaning only on the scalp, it is noninvasive and can be utilized directly by the user without the help of a doctor or nurse. Finally, we are effective because we don’t just give the user statistics but also give them the choice to fix it. That shift in causality makes our product unique.

Market Analysis

We plan to sell TARDIS commercially to any individual hoping to be more productive or to experience higher qualities of sleep and relaxation. Additionally, we hope to partner with both healthcare providers and educational institutions. Due to our product’s affordability, our customers will be able to be used by a larger population.

According to Grand View Research, the global behavioral health care software and services market size was valued at USD 2.1 billion in 2019. This market is expected to expand at a compound annual growth rate (CAGR) of 11.1% between 2016 and 2027. Around 21.5 million people in the US were reported to be suffering from disorders related to substance abuse in 2014 and of those, only 2.5 million people received the necessary treatment. We hope to increase this second number by making our product accessible and eliminating the stigma behind mental health care.

Demographically, we will target two main types of people. Older people (>45) are more likely to face neurological disorders while younger people (6-21) are likely to face mental health conditions. For example, an older woman may be suffering from Parkinson’s disease in which case TARDIS will help assist her brain functions. On the other hand, a younger teenage boy may be suffering from depression while in school and TARDIS would help his focus in school as well. Both of these patients will see a direct impact and even after taking off the TARDIS-cap, they will see long term benefits.

Our first target is to sell our products commercially to individual buyers. Consumers will have two options when buying our product. They have the option to buy both our chip and the modular EEG as a full product ready to use. However, if they do not wish to buy the full product, they have the option to buy just the chip where they can then use their own EEG, either third party or self made, and use TARDIS with the same experience. Any consumer that has trouble with focus or sleep can purchase our product whether they are diagnosed with a disease or not. This means that we can provide to a large range of audiences.

The second target is partnering with educational environments in order to reach a larger audience. We hope to partner with many different institutions including schools, libraries, community centers, makerspaces, and private education companies. These institutions can use TARDIS as tools to help enhance the learning environment. For example, if an innovator was working on a project at his local community center but can’t seem to concentrate he or she can use TARDIS as a way to monitor and assist his or her productivity.

Next, we plan to partner with healthcare providers and educational institutions in order to promote neuroscience education. Our product can be used as an instructional tool to educate young people about neuroscience. Currently, not many schools or educational facilities teach neuroscience and we hope to change that with our educational initiative.

Competitive Analysis

There are a few products currently in the market that are somewhat similar to TARDIS. First, there is NeuroPace, a pacemaker implanted into the brain designed to help epileptic and PTSD patients avoid long-term damage from seizures or attacks. This is somewhat different from TARDIS because we are much less intrusive and do not require a clinician’s support. Additionally, NeuroPace is designed to target a specific disorder, and while TARDIS can definitely help mitigate the effects of many disorders, we only want to help people understand how much they are really focused and when it is time for them to take a break. After all, self-love is of utmost importance!

There are some products that have similar ends like ours in aiming to help enhance a certain facet of our daily lives, but can only give passive feedback. For example, Urgotech allows users to play games after they wake up to analyze their sleep quality. This data can be used for so many beneficial purposes, which is what we aim to do. Luckily, such existing neurotech products only mean we have proof that such products are effective and safe.

Additionally, our product has an advantage over many neurotech products because of its zero-risk state and its low cost and maintenance. A hat with electrodes connected to a phone app is much easier to use and produce than high-end brain sensing devices like glasses or prosthetics. Anyone could go online and put together their own version of TARDIS according to our instructions, use our precoded software, and start using our product.

Finally, we have one of the largest competitors, the Apple Watch. Many Apple Watch applications aid in tracking sleep and they are very popular. However, all that the Apple Watch can do is track sleep. Users would have to be proactive if they want to fix their sleep. In short, the Apple Watch simply isn’t effective in aiding with sleep issues. TARDIS on the other hand, is effective in that it will aid users who have sleep or focus issues, not only by pointing out the issue, but, with consent, gently altering brain waves to aid in the process.

Cost

Overview of prototype, with product, cost, and any notes

TOTAL $103.00

Of course, this total may change due to shipping or even enhancements we may make. Additionally, we are in active talks to different mentors who are willing to provide hardware as well as grants giving students hardware. For example, Hack Club’s Summer of Making has provided us with OpenBCI materials as well as a few computing boards and other materials.

Additional:

Obviously this is all handy-dandy for the prototype itself, but a company is not just one piece of technology. We will need to market our product as well as reach out to potential partners to spread the word. Marketing is a vital tool to success and many of us have had experience as marketing leads for hackathons or team members in larger conferences.

Some avenues of growth we would like to expand into include Google SEO, social media marketing, educational videos about neuroscience that can also spread the word about our product, as well as working with ambassadors and representatives of large institutions to license and mass-purchase TARDIS for their organization. That last bit seems somewhat far-fetched, but it is very possible. Given the increase in emphasis in edutech and hands-on learning, it can be an effective strategy to teach students how to build their own EEG and their own version of TARDIS, connect it with our analysis board and software, and have something to call their own!

Other costs involved in operating TARDIS as a business would include incorporation, patenting, and marketing. The cost for incorporation costs approximately $500 with a $10-50 annual fee as an S corporation. Patenting will cost from $130-5,000 and beyond, so that will be a major sink for our funds.

Finally, let’s get into specifics of revenue. If we estimate each product costing approximately $115 to produce, including requisite operational costs and whatnot, we can sell the product at a price from a range of $184-218, depending on method of purchase. For the entire product pre-made and assembled, we foresee it’ll cost ~$218 (which is a 90% profit) while if someone hopes to only purchase the board, we can sell at a price of $184, a 60% profit. For purchase of licensing of our software (without hardware), we can charge a much lower price and even give educational discounts for hacker and builder organizations (i.e. Fablabs, computing clubs, hackathons…). From a purely product selling standpoint, this is a major success. Of course, with increases of demand, we plan to invest more into testing more effective and cheaper forms of TARDIS as well as additional features that can create an alternative product/enhancements for specific disorders or goals. This will mean we can expand into each niche field and earn a larger portion of revenue associated with such.

Funding Sources

Many members of our team have done previous research in electrophysiology and neural implant technology. This gives us the advantage of knowing many of the methodologies involved in creating such a biopack and gives us access to mentors and technology. We have experience with Blackrock and Matlab, which means we’ll be able to effectively do data analysis and create an RNN (recursive neural network) that can effectively analyze brain waves.

This doesn’t mean there aren’t costs involved in TARDIS. Firstly, let us look at the hardware aspect of the project. While we may already have some semblance of an EEG, we hope to put together a much better working prototype, and will need electrodes to put together an EEG. We have two rounds for initial seed funding (A & B)

During round A, we will focus on initial prototyping and R&D. In order to do this, we will require $4,000 in funds as well as funds for patenting (which can cost from $130 to $5,000, but we hope to research alternative methods or file personally to USPTO). This money will be used to create multiple iterations of prototypes, funds for analysis tools to ensure the safety and scientific bases of TARDIS, and product testing. We also hope to use this money to attend the innovation summit if we are selected. Additionally, we will require funds to patent TARDIS and pay for medical specialist analysis after we are done with our beta product. This way, we can be sure there is nothing that can go wrong in our users’ hands. Our two main funding sources for round A seed funding are Angel Investors and R&D grants. According to the Department of Health and Human Services, the U.S. president's budget granted USD 5.5 billion for the Substance Abuse and Mental Health Services Administration (SAMHSA) for the fiscal year 2020. We hope to apply and receive R&D grants from SAMHSA. In addition to SAMHSA grants, we hope to receive grants from the National Aeronautics and Space Administration (NASA). These grants include the Murep Innovation & Tech Transfer Idea Competition (MITTIC), the Center Innovation Fund (CIF), and the NASA Innovative Advanced Concepts Program (NASA NIAC). On top of R&D grants, we plan to talk to angel investors in order to both raise capital and build valuable connections that will help us with the prototyping process. The main groups we will talk to come from our team members’ areas. These include the Blu Venture Investors, the San Diego Angel Conference, and the Meda Angels.

During round B, we will already have a final prototype that has been thoroughly tested and it is time to keep IP, license, and commercialize our product. In order to do this, we will require $5,000. First and foremost, these funds will be used to commercialize. By utilizing google ads and SEO, outreach programs on social media (like instagram, facebook, and tiktok), as well as partnerships with related companies, we can be sure to grow a large user base. Even better, we partner with educational organizations our founders have already had previous connections with, such as Hack Club, IYNA,  Our main source of funding for round B seed funding will come from venture capital firms. We hope to receive funding from venture capital firms in the Washington D.C., San Francisco Bay, and San Diego areas, which will not only help us financially, but will also provide us with connections that will assist us in the process of commercializing and licensing TARDIS to our consumer base. These firms include 1776 (Washington, DC), DC Community Ventures (Washington, DC), Accel Partners (Palo Alto, CA), and Advanced Technology Ventures (Palo Alto, CA). Finally, some incubators may be beneficial to the growth of our product, such as applying for Beta Camp or LaunchX.  

TARDIS Supplemental

References

  1. Herrmann, C.S. et al. (2016) EEG oscillations: from correlation to causality. Int. J. Psychophysiol. 103, 12–21
  2. Buzsáki, G. (2006) Rhythms of the Brain. Oxford University Press
  3. Lustenberger, C. et al. (2018) High-density EEG characterization of brain responses to auditory rhythmic stimuli during wakefulness and NREM sleep. Neuroimage 169, 57-68
  4. Antony, J.W. and Paller, K.A. (2017) Using oscillating sounds to manipulate sleep spindles. Sleep 40, zsw068
  5. Helfrich, R.F. et al. (2014) Selective modulation of interhemispheric functional connectivity by HD-tACS shapes perception. PLoS Biol. 12, e1002031
  6. Suthana, N. et al. (2012) Memory enhancement and deep-brain stimulation of the entorhinal area. N. Engl. J. Med. 366, 502-510
  7. Riddle, J. et al. (2019) Causal evidence for the role of neuronal oscillations in top-down and bottom-up attention. J. Cogn. Neurosci. 31, 768-779
  8. Huang, T., & Redline, S. (2019, May 23). Cross-sectional and Prospective Associations of Actigraphy-Assessed Sleep Regularity With Metabolic Abnormalities: The Multi-Ethnic Study of Atherosclerosis. Retrieved December 24, 2020, from https://care.diabetesjournals.org/content/early/2019/05/21/dc19-0596.article-info
  9. Staudigl, S., Hanslmayr, S. (2013) Theta oscillations at encoding mediate the context-dependent nature of human episodic memory. Current Biology, 23, 1101-1106.

Figures and Additional Photos

5-core shielded cable, 2-2.5 meters required

$8.00

Twin core shielded audio cable, 1-2 meters required

$2.00

Electrodes

$5.00 per electrode, $30.00 total

Stimulating electrodes for second module

$28.00

Raspberry Pi

$35.00

Total

$103.00

Prototype