Note: Descriptions are shown in the official language in which they were submitted.
CA 2961228 2017-03-20
PROVISIONAL PATENT APPLICATION
Sidney GOIAME
jean-Baptiste TUENN
March 20th, 2017
Wearable device to facilitate mindfulness practices with brain
activity analyzer and brain stimulator, and methods thereof
ABSTRACT
Aweaxable device to facilitate mindfulness practices with brain activity
analyzer and brain stimulator: the kind of portable device described here
is designed as a comfortable and lightweight headband, to capture and
analyze the user' s brain activity, and to deliver a. non-invasive brain
stimulation along with a, mindfulness audio guide, in order to facilitate
the practice of mindfulness meditation.
Also described herein are the methods to heighten attention, mental focus,
and eventually facilitate mindfulness by combining the use of
non-invasive brain stimulation, cognitive assessment, pre-recorded or
live mindfulness audio instructions, and real-time monitoring of the
user' s brain activity through wireless communication.
The technical specifications of an example of such portable device and
methods are presented hereby.
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CLAIMS
What is claimed is:
Any and all features of novelty disclosed or suggested herein, including
without limitation the following:
1. A system comprising: one brain activity analyzer, one brain stimulator,
one audio guiding system, one user interface, one user terminal, one
remote server.
2. The system of claim 1 wherein the user is directly interacting visually
and through touch with the user interface, transmitting signals to the
brain activity analyzer and receiving signals from the brain stimulator
and the audio guiding system.
3. The system of claim 2 wherein the brain activity analyzer, the brain
stimulator, the audio guiding system, and the user interface are all
connected to the user terminal.
4. The system of claim 3 wherein the user terminal is able to connect to
a remote server and exchange data anonymously.
5. The system of claim 4 wherein the remote server can handle data,
anonymously from one 'master' user terminal, and several 'slave' user
terminals.
6. The system of claim 5 wherein the brain activity analyzer is able to
identify the current state of mind of the user, transcribe it into an
electrical signal, classify it according to a number of cri teria., and
transmit the data to the user terminal.
7. The system of claim 6 wherein the brain activity analyzer could consist.
in a number of dry electrodes applied on one or several locations on the
user' s scalp, identifying the current state of mind of the user by
elec troencephalogra.phy.
8. The system of claim 7 wherein the brain activity analyzer could record
the user' s alpha., gamma and theta brain waves, as well as any event-related
potential.
9. The system of claim 6 wherein the brain activity analyzer could consist.
in a number of near-infrared sensors identifying the current state of mind
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of the user by functional near¨infrared spectroscopy.
10. The system of claim 6 wherein the brain stimulator is able to
non¨invasively influence the connectivity and/or function and/or the
plasticity of the user' s brain to facilitate the practice of mindfulness
meditation, based on the data received from the user terminal_
11. The system of claim 10 wherein the brain stimulator could consist in
a, number of dry electrodes on one or several locations on the user' s scalp
emitting a. low amplitude transcranial direct electrical_ current, for the
purpose of heightening attention, mental focus, equanimity, and
eventually facilitating mindfulness.
12. The system of claim 10 wherein the brain stimulator could consist in
a number of low¨power lasers or light¨emitting diodes on one or several
locations on the user' s scalp emitting a. specified set of wavelengths
of laser, for the purpose of heightening attention, mental focus, -
equanimity, and eventually facilitating mindfulness.
13. The system of claim 10 wherein the audio guiding system is able to
deliver pre¨recorded digital mindfulness instructions, or live digital
instructions from a. remote mindfulness teacher.
14. The system of claim 13 wherein the audio guiding system is delivering
pre¨recorded digital mindfulness instructions, based on the chlta received
from the user terminal.
15. The system of claim 14 wherein the audio guiding system is able to
deliver pre¨recorded digital cognitive assessment instructions.
16. The system of claim 15 wherein the user interface is available on the
user' ssmartphone, tab let, smartwatch, or electronic device allowing for
visual and touch command with wireless connection functionalities.
17. The system of claim 16 wherein the user interface is able to offer
control to the user over its usage of and interaction with the system,
and display consolidated and graphic live information about the current.
state of mind of the user.
18. The system of claim 17 wherein the user interface is able to send
wirelessly the electronic signal corresponding to the user' s command to
the user terminal, and to receive updated data about the current usage
of the system frdm the user terminal.
19. The system of claim 18 wherein the user terminal is able to identify
any unique user by an individual account through the user interface.
20. The system of claim 19 wherein the user interface is able to receive
and collect data from the brain activity analyzer, run an algorithm able
to modulate the data, to be sent to the brain stimulator and audio guiding
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system, as well as to update the information provided to the user through
the user interface.
21. The system of claim 20 wherein the user interface is able to send the
user's collectedand synthesized brain data anonymously to aremote server,
and to receive updates of algorithm, firmware and software front a, remote
server.
22. The system of claim 21 wherein the remote server is able to receive
the collected and synthesized anonymous brain data from any user, to
establish and update reference brain data, and store it safely.
23. The system of claim 22 wherein the remote server is able to allow a,
restricted number of administrators and superusers able to access the
collected and synthesized anonymous brain data.
24. The system of claim 23 wherein the remote server is able to connect
the user terminal from one mindfulness teacher with a number or user
terminals from mindfulness meditation practitioners.
25. The system of claim 24 wherein the remote server is able to handle
the connections between the master user terminal of one mindfulness
teacher and a number of slave user terminals of mindfulness meditation
practitioners.
26. The system of claim 25 wherein the remote server is able to use the
collected and synthesized anonymous brain data from a. user and to suggest
to that user the connection to the class offered by an available
mindfulness teacher through their respective user terminals.
27. The methods pertaining to the system of claim 26 comprising signal
processing, pattern classification, and contingency handler, for the
purpose of ensuring an appropriate and safe neuromodulation throughout
each session.
28. The methods of claim 27 wherein signal processing in the user terminal
allows for collecting electrical signals front the brain activity analyzer
including the source of each, filtering them to eliminate all unwanted
noise, and identifying each component relevant for the analysis of the
current state of mind of the user.
29. The methods of claim 28 wherein signal processing in the user terminal
could resort to collecting electrical signals from the brain activity
analyzer such as that of claim 8 including the electrodes fmilwhich each
stems, filtering them to eliminate all unwanted noise and frequencies
related to brain activity not relevant to the methods, and accordingly
identifying the frequency bands and event-related potentials relevant for
the analysis of the current state of mind of the user.
30. The methods of claim 28 wherein signal processing in the user terminal
allows for collecting the data of the user cognitive tasks from the user
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interface to improve the assessment of the current state of mind of the
user.
31. The methods of claim 30 wherein signal processing in the user terminal
could resort to collecting data of visual and working memory tasks from
the user interface to improve the assessment of the current state of mind
of the user.
32. The methods of claim 30 wherein pattern classification in the user
terminal allows for handling the classification of the components
provided by the signal processing of' claim 28, according to a number of
categories and rules, to the time course of the each component, to the
history of the user, and to reference brain data, obtained from a, remote
server.
33. The methods of claim 32 wherein pattern classification in the user
terminal could resort to handling the classification of the frequency
bands and event-related potentials of claim 29, and of the data of visual
and working memory tasks of claim 31, according to a number of categories
and rules, to the time course of the each component, to the history of
these frequency bands, event-related potentials, and data of visual and
working memory tasks collected from previous sessions of' the same user,
and to reference brain data, obtained from a. remote server.
34. The methods of claim 32 wherein pattern classification in the user
terminal allows for providing to the audio guiding system and the brain
stimulator the appropriate neuromodulation commands, according to the
classification of the current state of mind of the user.
35. The methods of claim 34 wherein pattern classification in the user
terminal could resort to providing to the audio guiding system and the
brain stimulator the appropriate mindfulness and low amplitude
transcranial direct electrical current instructions respectively,
according to the classification of the current state of mind of the user.
36. The methods of claim 34 wherein contingency handler in the user
terminal allows for identifying, based on the brain data collected, on
the personal data, and on the feedback provided through the user interface,
any situation that deviate from the expected course of the session or that
could disserve the user in any way, and accordingly for limiting the
functionalities of the device or terminating the session.
37. The methods of claim 36 wherein contingency handler in the user
terminal could resort to identifying, based on the frequency bands and
event-related potentials of claim 29 , on the data of visual and working
memory tasks of claim 31, on the personal data provided at the time of
the creation of the user profile and verified to some extent before each
session, and on the feedback requested after the termination of a session
provided through the user interface, any abnormality of the system, any
contraindicated condition of the user, and any unsuitable evolution of
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the stale of mind of the user, and accordingly to disable the brain
stimulation functionality or terminate the session.
DESCRIPTION
Field of the invention
This invention consists in a, wearable brain wellness device to facilitate
the practice of mindfulness meditation as well as the methods to benefit
from its wholesome effects, in order to to promote personal wellbeing and
social intelligence.
Background of the invention / Description of the related art
Since they were first introduced to the Western world 40 years ago,
mindfulness practices have proved to yield benefits for the body and the
mind, to prevent physical and mental illness in healthy individuals, to
aid clinical patients with their psychological conditions, to relieve
hospitalized patients from their physical condition, and even to pacify
relationships in prisons by giving purpose to the inmates.
However, despite their proven benefits for the body and the mind,
mindfulness practices are still facing a number of obstacles: I. the
belief that they are a religious practice; 2. the distrust of their
concrete effects; 3. the difficulty to find time or a, place to practice;
4. the difficulty to reach the necessary level of concentration.
Our device and methods are addressing these issues, not by replacing
existing mindfulness practices, but by popularizing them and increasing
awareness about their holistic benefits: 1. for those who believe that
meditation is a, religious practice, resorting toanelectronic device will
dissipate any prejudice; 2. for those who believe that meditation is just
a. trend and does not yield any benefit, relying on scientific proofs,
partnerships and certifications will grant credibility as for the
concrete effects; 3. for those who do not have time or do not know a. place
to practice: our device will allow anyone to practice according to their
schedule and in the comfort of their how; 4. for those who give up because
it is too difficult, we are introducing brain stimulation to facilitate
the practice and emphasize on the reward.
There are today 3 kinds of devices and services related to our invention:
brain analyzing devices resorting to EEG (Electro Encephalo Graphy)
technology to decode the user's mood and behavior (Muse, Neurosky, FMOT1V
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Epoc+ & Insight, etc.), brain stimulating devices resorting to tDCS
technology to target specific brain regions and drive plastic or
functional changes (Foc.us, Halo, Thync, etc.), and mindfulness related
electronic services assisting users in their practice owing to advice from
experienced professionals (lIeadspace,Smiling Mind, Buddhify, The
Mindfulness app, Spire, etc.).
Our device and methods are following the trend of wearable brain wellness
device, but to the authors' knowledge, they are the first to offer -a,
brain activity analyzer and a, brain stimulator along with a, user-friendly
interactive graphic interface for the purpose of facilitating mindfulness
practices.
Summary
This present invention consists in a. portable device designed as a.
comfortable and lightweight headband, to capture and analyze the user' s
brain activity, and to deliver a, non-invasive brain stimulation along with
a. mindfulness audio guide, in order to facilitate the practice of
mindfulness meditation.
The device could for example comprise: a number of dry electrodes applied
on one or several locations on the user' s scalp, identifying the current
state of mind of the user by electroencephalography; a number or dry
electrodes on one or several_ locations on the user' s scalp emitting a
low amplitude transoranial direct electrical current; an audio guiding
system able to deliver pre-recorded or live digital mindfulness
instructions, and pre-recorded digital cognitive assessment
instructions.
This present invention also consists in the methods to heighten attention,
mental focus, equanimity, and eventually to facilitate mindfulness, by
combining signal processing, pattern classification, and contingency
handler, for the purpose of ensuring an appropriate and safe
neuromodulation throughout each session.
The methods could for example comprise: signal processing by collecting
the electrical signals from the electrodes of thelyminactivity analyzer,
filtering them to eliminate all unwanted noise and frequencies related
to brain activity not relevant to the methods, accordingly identifying
the relevant frequency bands and event-related potentials, and collecting
data, of visual and working memory cognitive tasks; pattern classification
by handling the classification of the components provided by signal
processing, according to a number of categories and rules, to the time
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course of the each component, to the history of the user, and to reference
brain data obtained from a, remote server; contingency handler by
identifying, based on the brain data, collected, on the personal data, and
on the feedback provided through the user interface, any abnormality of
the system, any contraindicated condition of the user, and any unsuitable
evolution of the state of mind of the user, and accordingly to disable
the brain stimulation functionality or terminate the session.
Brief description of the drawings
The attached 11 figures offer a. tentative representation of the
specifications of the present device and methods.
Figure 1: describes the 6 components of the device, along with information
on their number, nature, function, and position.
Figure 2: presents the connection between these 6 components, as well as
the kind of information typically exchanged. A green arrow stands for a
unilateral communication, and red for bilateral.
Figure 3: describes in a chronological order the typical list of actions
from each of the 6 components during the course of an individual and normal
session.
Figure 4: illustrates the bask algorithnirun by the system over the course
of a. normal session.
Figure 5 and 6: links the types of stimulators and sensors available, the
component to which they belong, their incoming and outgoing signals, their
individual. and concomitant effects and processing means respectively.
Figure 7: provides a list of tDCS exclusion criteria, according to those
available solely through asking the user and those also identifiable
through the brain activity analyzer.
Figure 8: summarizes the main clinical traits of the OCS exclusion
criteria, identifiable through the brain activity analyzer.
Figure 9: provides a list of the main identified Low Level Laser Therapy
contraindications and precautions.
Figure 10: provides an additional list of specific functionalities and
warning messages for each of the 6 components of the device.
Figure 11: shoAs two visuals of a, practical device including all the
features of the present invention.
Detailed description
10. This invention consists in a. wearable brain wellness device to
facilitate the practice of mindfulness meditation as well as the methods
CA 2961228 2017-03-20
to benefit from its wholesome effects, in order to to promote personal
wellbeing and social intelligence.
12. Mindfulness practices have existed for millennia. They stem from
several Buddhist meditation traditions, mostly the Theravada, or Mahayana.
Buddhist styles of meditation more focused on relaxation, and the
Vajrayana, tradition (also referred to as Tantric Buddhism) more focused
on arousal.
14. Among the first category, Shamatha and Vipassana are among the most
popular, whereas Visualization of self-generation-as-Deity and Rig-pa,
are for the second.
16. In 1979, a, 35-year-old Buddhist meditation student and MIT-trained
molecular biologist named Jon Kabat-Zinn creates the Mindfulness-Based
Stress Reduction (ABSR) program. It is possibly the landmark identifying
the inception of the word 'mindfulness' and its practice in the Western
world.
18. In 1990, there are 12 published papers about mindfulness in medical
treatment. In 2015, more than 3400 research articles had been published
on mindfulness, about 1,000 during 2013-2015 alone. And the numbers are
showing exponential growth.
20. The reason for this sustained and increase interest are simple:
mindfulness practices have scientifically proved to yield benefits fer
the body and the mind, to prevent physical and mental illness in healthy
individuals, to aid clinical patients with thei r psychological conditions,
to relieve hospitalized patients from their physical condition, and even
to pacify relationships in prisons by giving purpose to the inmates.
22. In short, mindfulness practices seem to illustrate the possibility
for almost anyone to getbettercontrol of themselves, to live a healthier,
more fulfilling life, free of cravings born out of situations and
circumstances one has no power on -a motto all too common in Western
societies.
24. What' s more, the practices seem to find an unlimited variety of
applications, and everyday there seems to be a, new way to yield the
physical and mental benefits of mindfulness.
26. The rationale behind this new trend is certainly its efficacy and
versatility, but also the positive reception from most strata or the
population and thus the economic potential of its applications.
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28. The National Health Interview Survey accounted for 18 million U. S.
adults using some form of meditation in 2012, that' s about 8% of the
population. The corresponding industry. is valued at more than 1 hi liion
dollars.
30. Among the hundreds of apps available for smartphones and tablets, the
top app Headspace recently raised $30 million and has been downloaded more
than 6 million times, whereas the pioneer headband company Muse generates
$8 million per year.
32. Mindfulness has found a very keen audience in the office space as
proved by a survey anticipating 45% of US employers in 2017 to offer some
kind of mindfulness training priced between $500 and $10, 000. The example
of Aetna is notable: after introducing a mindfulness curriculum to their
employees, they noticed that paid medical claims dropped by 7.3% amounting
to about $9 million in savings.
34. Mindfulness has also been an effective component of rehabilitation
therapies and has shown for example to be twice as good as gold standard
therapy at helping people quit smoking. Considering the costs of substance
abuse related to crime, lost work productivity and healthcare exceeds $700
billion annually, it is sensible to promote the use of mindfulness based
therapies.
36. Very notably, a number of mindfulness based programs offered in
prisons have yielded fantastic results, both during incarceration by
pacifying the relations between the inmates and the personnel and giving
purpose to the former, but also after by significantly reducing the rate
of recidivism.
38. Indeed, according to the conclusions of a, 2005 report by the Bureau
of Justice Statistics stating that out of 405' 000 prisoners released in
30 states, 77% were arrested for a new crime within 5 years. While out
of the 182 graduates of the Guiding Rage into Power Program at San Quentin
State Prison, in 5 years 53 have been released by a. parole board and none
have conic back to prison, saving more than $3 million every year.
40. The economic justifications of this invention are therefore very real,
but the social aspect is even more important.
42. As such, this invention aims at popularizing the existing mindfulness
practices and at increasing awareness about their holistic benefi ts. This
invention does not aim at replacing the existing practices.
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44. indeed, despite their proven benefits for the body and the mind,
mindfulness practices are still facing a. number of obstacles that are
hindering their even wider spread: 1. the belief that they are a religious
practice; 2. the distrust of their concrete effects; 3. the difficulty
to find time or a place to practice; 4. the difficulty to reach the
necessary level of concentration.
46. This invention plans on addressing these issues and lowering the entry
barriers to allow the greater number to benefit from the advantages of
the practices.
48. Considering that this invention consist in an electronic device, the
prejudice that meditation is a religious practice will be ruled out.
50. Considering that this invention relies on scientific proofs, and later
on partnerships and certifications, the concrete effects of mindfulness
meditation will be substantiated.
52. Considering that this invention offers the flexibility for the users
to practice according to their schedule and in the comfort of their home,
the difficulty to find time or a. place to practice will be greatly reduced.
54. Considering that this invention allows to heighten attention, mental
focus, equanimity, and eventually to facilitate mindfulness, the
challenge to reach and maintain the necessary level of concentration will
he made easier, and the benefits of the practice made more accessible.
56. Today there are mostly 3 kinds of commercial devices and services that
claim to either help users enhance the control of their own mind, or help
in the practice of some form of meditation.
58. There are brain analyzing devices resorting for the most part to EEG
(Electro Encephalo Graphy) technology to decode the user's mood and
behavior: Muse, Neurosky, EMOTiV Epoc+ & insight, and a. few other offer
headbands and apps or softwares to identify arid understand the functioning
of the user' s brain. However these do not include any form of active
stimulation.
60. There are brain stimulating devices resorting for the most part to
tDCS (transeranial Direct Current Stimulation) technology to target
specific brain regions and drive plastic or functional changes: Foe. us,
Halo, Thync, offer wearable apparatuses to modulate the functioning of
the user' s brain. However these do not include any form of monitoring of
CA 2961228 2017-03-20
the user' s stale ofmnindbefore, during or after the stimulation. Moreover,
only to a, very limited extent are they offered for a. purpose related to
some form of meditation.
62. There are mindfulness related electronic services assisting users in
their practice owing to advice from experienced professionals, mostly
apps offered form smartphones and tablets: Headspace, Smiting Mind,
Buddhify, The Mindfulness app, Spire, to name a. few are focused on
mindfulness or some form of meditation, but do not include any aspect of
brain analysis or stimulation.
64. Considering the state of the art, this invention is to the knowledge
of its creators the fist of its kind to include all 3 components: brain
analysis, brain stimulation, for the purpose of mindfulness practices.
66. This present invention consists in: a device including a, brain
analysis component, a, brain stimulation component, for the purpose of
mindfulness practices; methods to use this device itia variety of contexts,
to properly identify the user' s current state of mind, to help the user
make progress in the practice of mindfulness meditation, while ensuring
the user' s safety by preventing any adverse effect.
68. The device is designed as a, comfortable and lightweight wearable
headband, to capture and analyze the user.' s brain activity, and to deliver
a, non¨invasive brain stimulation along with a, mindfulness audio guide,
in order to facilitate the practice of inindfulness meditation. The device
would also bear several buttons and light indicators for the comfort and
information of the user.
70. Initially, the device would comprise a, number of dry electrodes
between 3 and 9 to perform the brain analysis, depending on the target
audience and specific outcome expected.
72. Dry electrodes enable most if not all users to benefit from the EEG
technology, irrelevantly of their hair density, and without the hassle
of applying conductive gel, while maintaining an impedance within the
acceptable range to ensure the proper flow of current.
74. The locations chosen on the user' s scalp are chosen among this list
according to the international 10-20 EEG system positioning: Fz, Cz, Pz,
F3, F4, C3, C4, P3, P4.
76. These locations have proven to be the most appropriate to assess the
brain activity by measuring the Alpha, Gamma. and Theta waves, as well as
ERPs (Event Related Potentials).
CA 2961228 2017-03-20
78. Indeed, studies have established a, number of reliable indicators of
the state of mindfulness: a, state-related slowing of the alpha. rhythm (8
-12Hz) in combination with an increase in the frontal alpha power, theta
band (3 - 81Iz) activity and amplitude found to increase, largest imnplitude
and synchronization increases of gamma band activity (around 40 Hz)
reported in highly advanced meditators, and larger P300 amplitudes after
mindfulness training.
80. The device would therefore initially resort to LEG technology to
measure the brain waxes and event related potentials in order to assess
the current state of mind of the user, and over time the evolution in the
practice of mindfulness meditation.
82. In later evolutions, it is not excluded that the device would resort
to other technologies as well, such as fNIRS (functional_ Near Infra Red
Spectroscopy), to provide an ever more reliable analysis of the user'
s brain.
84. Initially, the device would comprise a. number of dry electrodes
between 1 and 4 to perform the brain stimulation, depending on the target
audience and specific outcome expected.
86. Dry electrodes enable most if not all users to benefit from the tDCS
technology, irrelevantly of their hair density, and without the hassle
of applying conductive gel, while maintaining an impedance within the
acceptable range to ensure the proper flow of current.
88. The locations chosen on the user' s scalp are chosen among this list
according to the international 10-20 LEG system positioning: anode over
F8/F10, cathode over the left mastoid, clavicular, or ear region, F3, F4.
90. These locations have proven to be the most appropriate to stimulate
the brain activity by increasing attentional control, enhancing working -
memory, increasing self-awareness and reducing cravings.
92. Indeed, studies have established a body of observations from users
stimulated on these locations while receiving mindfulness and cognitive
instructions: frontal alpha power increase during meditation, alpha.
frequency decrease during meditation, posterior alpha power increase
during arousal, posterior alpha power decrease during target response,
frontal P300 amplitude increase duringmeditation, frontal P300 amplitude
decrease after rest, frontal theta power increase during and after
meditation, posterior theta power increase after meditation, frontal
theta, power decrease after meditation, bilateral gamma power increase
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during meditation, bilateral gamma synchronicity increase during
meditation.
94. The device would therefore initially resort to OCS technology to
stimulate the user' s brain and foster a stale of mind similar to that.
of mindfulness meditation. The device would provide the user an external
button to immediately interrupt the brain stimulation, for example on the
right earphone.
96. In later evolutions, it is not excluded that the device would resort
to other technologies as well, such as LLLT (Low Level Laser Therapy),
to provide an ever more reliable stimulation of the user' s brain.
98. To yield its wholesome mindfulness outcome, the brain stimulation has
to be accompanied by an appropriate set of mindfulness and cognitive
instructions. Together, they allow for heightening attention, mental
focus, equanimity, and eventually facilitating mindfulness.
100. For this reason, the device also includes an audio guiding system.
It consists in a couple of earphones allowing to deliver the mindfulness
and cognitive instructions in an audio format. These earphones have
independent volume control buttons available to the user, for example on
the left earphone.
102. The mindfulness instructions are available by two means: the user
can listen to a set of pre¨recorded digital mindfulness instructions,
delivered according to the appropriate mindfulness program suggested
based on the user' s current stale of mind and progress, and eventually
chosen by the user.
104. All mindfulness instructions will be provided by certified
mindfulness instructors, and the programs created to match with the
purpose and objectives of this invention.
106. If the user is connected to the internet and the device connected
to one of the remote servers, the user can also choose to listen to one
or the live mindfulness courses offered by a. certified mitulfulness
instructor. The user will be suggested a, list of courses compatible with
its current state of mind and progress.
108. The cognitive instructions aim at assessing the visual attention and
working memory of the user by measuring the brain activity, responses and
reaction times.
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110. Programs including these cognitive instructions will be proposed
before or after the mindfulness instructions in order to establish-a,
baseline and quantify the progress and transfer effects of the user.
112. All cognitive instructions will he provided by appropriate
instructors, and the programs created to match with the purpose and
objectives of this invention.
114. The instructions are provided through the audio guiding system, and
also through the user interface. Indeed, at this time the user will be
requested to use a. visual interface and answer to the instructions,
possibly through a touch screen.
116. The user interface is provided for the user to interact with the
system, through a, wireless connection with the user terminal.
118. The user interface allows mostly for controlling the session,
answering the cognitive assessments, and display current status of the
user.
120. The user interface receives commands and inputs from the user and
transmits them to the user terminal for the purpose of updating and
modulating the user' s session. In turn, the user interface receives a.
feedback from the user terminal in order to update the current status of
the user and the cognitive assessments.
122. The user interface is offered through an app on smartphones, tablets,
smartwatches, and through a, computer software.
124. The user terminal holds a, central part in the device as it: receives
the user' s commands and inputs from the user interface for the purpose
of updating and modulating the user' s session, and sends hack updates
of the current status of the user and the cognitive assessments; receives
the electrical signals collected by the brain activity analyzer; sends
commands to the audio guiding systems to update the mindfulness and
cognitive instructions; sends commands to the brain stimulator to
initiate and handle the appropriate stimulalion; sends classified and
anonymous user statistics to a remote server and receives updates of the
algorithms supporting the methods and of the software and firmware.
126. The user terminal is likely to be directly integrated in the device,
and to communicate with the remote server wirelessly, possibly through
the user' s smartphone or tablet or smartwatch or computer; it is also
likely to be easily removable from the device.
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128. The user terminal is the commander in chief of the operations
happening during a session, and executes the methods.
130. The remote server holds all users' classified and anonymous user
statistics, and also generates baselines to establish global user
profiles. These serve statistical purposes and can be accessed by a.
limited number of server administrators. These administrators can in turn
create access for some privileged user to some of the user information,
in particular for scientific or healthcare purposes.
132. The remote server sends back to user terminals updates of the
algorithms supporting the methods and of the software and firmware.
134. The remote server is also used to cotutectanoster user terminal owned
by a, user identified as a certified mindfulness instructor, and a. number
of slave user terminals owned by regular users seeking for live
mindfulness courses.
136. The connection is offered based on the user' s current and historical
brain data, as well as on the kind of instructions offered by the
mindfulness instructor.
138. Along with the aforementioned device, this invention also consists
in the methods to heighten attention, mental focus, equanimity, and
eventually to facilitate mindfulness, by combining signal processing,
pattern classification, and contingency handler, for the purpose of
ensuringan appropriate and safe neuromodulation throughout each session.
140. The signal processing could rely on: collecting electrical signals
from the brain activity analyzer including the electrodes from which each
stems, filtering them to eliminate all unwanted noise and frequencies
related to brain activity not relevant to the methods, accordingly
identifying the relevant frequency hands and event-related potentials,
and collecting data of visual and working memory tasks for the analysis
of the current state of mind of the user.
142. The user is naturally going to generate brain waves, whether with
or without the brain stimulation enabled. Based on the status of the user
(at rest, meditating, stimulated or not) the data, from the user' s brain
activity is being collected by the brain activity analyzer.
144. The signal processing is responsible for making sense out of the
electrical signals collected from the brain activity analyzer by
filtering them, and identifying the indicators of mindfulness.
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146. These indicators are established based on the scientific
observations of mindfulness meditation prantitioners and of individuals
stimulated on these locations while receiving mindfulness and cognitive
instructions.
148. The pattern classification could rely on: handling the
classification of the frequency bands and event-related potentials, and
of the data of visual and working memory tasks, according to a, number of
categories and rules, to the time course or the each component, to the
history of these frequency bands, event-related potentials, and data, of
visual and working memory tasks collected from previous sessions of the
same user, and to reference brain data, obtained from a. remote server.
150. The pattern classification could also provide the audio guiding
system and the brain stimulator the appropriate mindfulness and low
amplitude transcranial direct electrical current instructions
respectively, according to thedassification of the current stateofmind
of the user.
152. The pattern classification is responsible for determining the right
course of action based on the data from signal processing, in order to
meet with the objectives of the user and the targets of the session.
154. The contingency handler could rely on: identifying, based on the
frequency bands and event-related potentials, on the data, of visual and
working memory tasks, on the personal data, provided at the time of the
creation of the user profile and verified to some extent before each
session, and on the feedback requested after the termination of a session
provided through the user interface, any abnormality of the system, any
contraindicated condition of the user, and any unsuitable evolution of
the state of mind of the user, and ancordingly to disable the brain
stimulation functionality or terminate the session.
156. An abnormality' of the system is identified by any software or hardware
response that would differ from that which is expected, for example:
sudden end of ongoing session, loss of power, of electrical connectivity,
of internet connectivity, command from the user to interrupt the brain
stimulation, or download of a. critical update.
158. The criteria used by the contingency handler to trigger a, warning
signal consist in part or the following list identified tDCS exclusion
criteria: brain not fully developed (user under aged), schizophrenic
traits, epilepsy, depression, addiction, pregnancy, history of mentat
illness, seizures and neurological_ disorders, cognitive, vision, hearing
impairment, frequent headaches, cardiovascular condition, onmedication,
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head injury or skin disorder, presence of inetallic component in the head,
first or excessive usage of brain stimulator.
160. Some of these criteria. (brain not fully developed (user under aged),
schizophrenic traits, epilepsy, depression, addiction) can be to a. good
extent identified directly by the brain activity analyzer; this
information will therefore be taken into account in the pattern
classification to determine whether and how to enable the brain
stimulator.
162. All criteria, are assessed in an initial questionnaire asked to the
user on the creation ofapersonal account. By default, any criteria. picked
up by the brain activity analyzer or provided by the user in the initial
questionnaire will result in a. deactivation of the brain stimulator,
unless authorized by a valid clinical authority. All other
functionalities would remain available.
164. The sequence of events of a typical session can be described as
follows:
1. the user starts by turning on the system, in case of a status of low
battery detected by either the wearable device or the app or software
supporting the user interface, it will not be possible to start the system
unless all components hold a. sufficient. level of battery.
2. if the user is new, it will be necessary to create a new and unique
user account_ During the creation, it will be requested to fill in a. basic
questionnaire for the system to be aware of any noteworthy information
(such as a. contraindication) that would influence the proceedings of a.
mindfulness program. The user will also be asked to choose if the brain
data collected can be shared and uploaded to a, remote server for scientific
or healthcare purposes.
If the user is not new, a log in page on the user interface will allow
to access the functional ities of the device.
3. once the user has logged in, the device runs a. test to check the status
of all sensors (for example, the electrodes of the brain activity analyzer
and brain stimulator). It is possible that the user has to change or clean
a sensor, or to check that they are all correctly connected and possibly
fix them if loose.
4. if all sensors are online and fine, the user interface prompts the
user to put on the device, which then starts collecting user information
from the brain activity analyzer. According to the history of the user,
its current state of niitlik and the connectivity to the internet, the user
interface will offer a list of programs. Each program will likely start
with a. cognitive assessment and includea.pre-recordedor live mindfulness
course. The brain stimulator is not enabled in case the user meets with
any of the criteria requiring the deactivation of the brain stimulator;
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also the very first session will not enable the brain stimulator.
5. the program is ending by evaluating its effect, and the current status
of the user with regards to the personal objectives set and those of the
program.
6. the user can then go on with another program, or conclude the current
session. At the end of the session, the data collected is saved on the
user terminal as it will be taken into account to adjust the pattern
classification of subsequent sessions. If allowed by the user and if the
device is connected to the internet, the data collected is also uploaded
to the remote server.
7. eventually, the user is asked to provide a. personal feedback informing
of the perceived effects of the session, as well as of any issue or trouble
encountered. That data is uploaded to the remote server if the device is
connected to the internet.
8. the user is asked to confirm the shut down of the device, which will
turn itself off upon confirmation.
