WO2024050650A1 - Système pour le diagnostic et la gestion de l'anxiété ou de la douleur - Google Patents

Système pour le diagnostic et la gestion de l'anxiété ou de la douleur Download PDF

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Publication number
WO2024050650A1
WO2024050650A1 PCT/CL2022/050089 CL2022050089W WO2024050650A1 WO 2024050650 A1 WO2024050650 A1 WO 2024050650A1 CL 2022050089 W CL2022050089 W CL 2022050089W WO 2024050650 A1 WO2024050650 A1 WO 2024050650A1
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WO
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Prior art keywords
pain
anxiety
intervention
management
artificial intelligence
Prior art date
Application number
PCT/CL2022/050089
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English (en)
Spanish (es)
Inventor
Eduardo Alejandro CORNEJO ACUÑA
Original Assignee
Cornejo Acuna Eduardo Alejandro
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Application filed by Cornejo Acuna Eduardo Alejandro filed Critical Cornejo Acuna Eduardo Alejandro
Priority to PCT/CL2022/050089 priority Critical patent/WO2024050650A1/fr
Publication of WO2024050650A1 publication Critical patent/WO2024050650A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/369—Electroencephalography [EEG]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/369—Electroencephalography [EEG]
    • A61B5/372—Analysis of electroencephalograms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/369—Electroencephalography [EEG]
    • A61B5/372—Analysis of electroencephalograms
    • A61B5/374—Detecting the frequency distribution of signals, e.g. detecting delta, theta, alpha, beta or gamma waves

Definitions

  • the present patent application for invention is directed to a system and method for the diagnosis and management of anxiety and/or pain without medications, which through a portable electroencephalogram (EEG) sensor connected to a processing device, smartphone/TV Stick o Extended Reality Lens and an Artificial Intelligence Platform in the cloud (Cloud), allows the diagnosis and monitoring of a person's anxiety and pain and additionally develops an intervention for the management of these levels, by introducing the person to a 2D digital stimulation environment in the case of Smartphone/TV or 3D (Virtual or Extended Reality), which provides tools for anxiety reduction and pain management.
  • EEG portable electroencephalogram
  • Cloud Artificial Intelligence Platform in the cloud
  • Experiencing anxiety is a normal component of human existence. People with anxiety disorders often experience intense and persistent worry and fear about everyday situations. Anxiety disorders often involve sudden, repetitive episodes of intense anxiety and fear that peak within minutes (panic attacks).
  • anxiety disorders include generalized anxiety disorder, social anxiety disorder, specific phobias, among others. It is possible to have more than one anxiety disorder, and sometimes anxiety is the result of a medical condition that needs treatment.
  • pain is an uncomfortable sensation that indicates that something may be wrong. It may be constant, stabbing, electric, painful, pinching, or described in other ways. Sometimes it is just an annoyance, like a mild headache, other times it can be debilitating and even disabling.
  • the quantification of pain intensity is essential, not forgetting that pain is by definition an emotional and sensory experience.
  • Patent publication WO2018059645 describes a neurofeedback system for training to reduce skeletal muscle pain.
  • the system comprises a non-invasive EEG sensor for detecting the EEG signal of the person as well as a processor system, e.g. a tablet or the like, receives data values from the EEG sensor and calculates an EEG power magnitude within the EEG alpha band accordingly.
  • the processor system is programmed to determine a reference value indicative of the EEG alpha band power and determine, in real time, the EEG alpha band power in response to the EEG sensor data.
  • Patent publication US20200233485 describes a virtual reality (VR) device, system and lens for generating a continuous choreographed VR experience for a physical procedure that incorporates at least one procedural action associated with a physical sensation and potentially inducing a anxiety or pain response. Continued VR experience may modify perceptions of pain and anxiety associated with the procedure. While the device is in operation and used by the user, one or more virtual reality experiences are provided, each associated with a physical procedure.
  • VR virtual reality
  • Patent publication CN108324272 describes a device composed of electroencephalography signal acquisition equipment, a preprocessing module, an analysis and computing module, and a classification module.
  • Electroencephalography signal acquisition equipment is used to acquire EEG (electroencephalography) signals in resting states with eyes open and closed for 8 minutes;
  • the pre-processing module is used to extract four frequency bands delta, theta, alpha and beta from the EEG signals after processing such as downsampling, filtering and removing artifacts is carried out on the EEG signals;
  • the analysis and calculation module allows the anxiety coefficients to be calculated according to the LZC obtained, the values of the four frequency bands, and the coefficients of free anxiety, mild anxiety, and moderate and severe anxiety obtained can be used as judgment indices to examine the degrees of anxiety;
  • the classification module is used to apply support vector machines to build classification models of anxiety degrees with the help of input data that are anxiety coefficient characteristic matrices of crowds without anxiety, mild anxiety, and moderate and severe anxiety, and the anxiety coefficient characteristic
  • the patent publication WO2019172563 describes a system for providing a treatment experience in a hospital according to the present invention comprising: a head-mounted display (HMD) that is worn on a patient's head to display a virtual reality screen ( VR) or augmented reality (AR); an integrated device to which a hand gesture recognition sensor is attached to recognize the patient's hand gesture; a guardian display monitor for viewing by the guardian and the patient's medical team; and a computer for communicating with the integrated device, providing the integrated device with treatment experience content that allows a virtual experience of a treatment process in a hospital, by receiving the patient's voice signal or a hand gesture signal detected by the device integrated, providing the integrated device with interactive treatment experience content corresponding to the received signal, mirroring a screen identical to a content screen provided to the integrated device, and displaying the mirrored screen on the watchdog display monitor.
  • the present invention can reduce a patient's anxiety and stress by providing a VR or AR based treatment experience service.
  • Patent publication W02020204810 discloses a process for identifying and extracting electroencephalogram (EEG) signals related to pain.
  • the process comprises receiving, from one or more trials, EEG data for each trial; determine a current density for each signal; estimating the current density for a set of regions of neural activity of interest, based on the calculated current density; and calculating at least one spectrum characteristic for each test based on the estimated current density. Therefore, the mean and variance of the changes in the EEG data between the EEG data labeled as indicative of a pain state and the EEG data labeled as indicative of a pain-free state can be calculated for each region. of interest from neural activity, and pain-related information can be calculated.
  • the EEG signals are They can identify based on at least one region of interest in which the variance is below a predetermined threshold.
  • the system is responsible for the interpretation of brain information, classification and delivery of results. Likewise, a mechanism identifies patterns, underlying structure or distribution in the data obtained, to learn and infer patterns in the brain data set.
  • the prediction of anxiety and pain is carried out through Supervised Learning, where a trained brain data set allows determining the appropriate algorithm for the predictive model, this allows determining the input characteristics of the training data set, which You will need to have sufficient knowledge to accurately predict your anxiety and/or pain level output.
  • the system is monitored to evaluate the accuracy of the model and whether it predicts the correct outcome.
  • the system of the invention incorporates a neural feedback mechanism or Neurofeedback incorporated into the Intervention (I) that allows real-time adaptation of the visual and auditory relaxation experience from the reading of brain waves. and in this way deliver real-time feedback to the user and/or patient during the exercise.
  • Intervention incorporated into the Intervention (I) that allows real-time adaptation of the visual and auditory relaxation experience from the reading of brain waves. and in this way deliver real-time feedback to the user and/or patient during the exercise.
  • the data collected by the Cloud platform has the objective of being analyzed and processed to deliver results to the person in graphic form, about their main metrics that intervene in the manifestation of anxiety and pain, where the user and/or patient can visualize the level of anxiety and level of pain resulting in a user panel (dashboard) which can be consulted individually on a computer device or smartphone, to track their progress and even receive alerts that allow you to take action to avoid acute symptoms of anxiety or pain (predictive characteristic).
  • system of the invention incorporates a calculation and learning engine based on artificial intelligence (machine learning), which provides a method for the prediction and prevention of the exacerbated chronic pain event according to the information and monitoring of the brain waves associated with anxiety and stress.
  • machine learning artificial intelligence
  • system of the invention incorporates a feature for the online measurement and recording of the levels of attention and relaxation using the brain sensor, which provides a mechanism for real-time monitoring of these levels, which can affect anxiety and pain crises, facilitating detection prior to the triggers to manage them early.
  • the object of the present invention is to provide a system and method for the diagnosis and management of anxiety and pain in people, using portable electroencephalogram (EEG), Extended Reality, and Artificial Intelligence tools, which can be developed by people in their home. , work, health center, during hospitalization or from anywhere.
  • EEG portable electroencephalogram
  • Extended Reality Extended Reality
  • Artificial Intelligence tools which can be developed by people in their home. , work, health center, during hospitalization or from anywhere.
  • Another object of the present invention is to incorporate the intervention (Block I) into the multimodal therapy used for the management of acute pain, facilitating the reduction of drugs and analgesia while maintaining effectiveness, reducing doses, side effects and potential adverse reactions. of drugs and analgesia.
  • Another object of the present invention is to provide a system and method for the predictive diagnosis of exacerbated pain, based on brain wave information, analog pain and anxiety rating scales and artificial intelligence (machine learning), which allow the prediction of the pain event. Chronic pain exacerbated days before its appearance.
  • Another object of the present invention is to provide a system and method to adjust drug doses and analgesia (reduce doses), in patients with risk of hemorrhage, alteration of kidney function, with alteration of liver function, alcoholics, with a history of accident. cerebral vascular disease, coronary heart disease, the elderly or with patients with risk factors for agranulocytosis (e.g. chemotherapy).
  • Another object of the present invention is to provide a Neural Feedback method available in Block I, which allows visual elements and/or objects in the 2D or 3D exercise environment to be synchronized with the brain waves of the user and/or patient in real time, to inform the user and/or patient of their progress in the development of their exercise.
  • Another object of the present invention is to provide a system and method for the diagnosis of anxiety, based on brain wave information, and processing based on artificial intelligence (machine learning), which as a result provides a diagnosis of anxiety through different levels of intensity.
  • Another object of the present invention is to provide a system for the implementation of an intervention for collaborative anxiety and pain management, which can be carried out in a group with other patients (VR modality), with the aim of humanizing the anxiety experience. and pain in the framework of a hospitalization, which suggests an increase in the improvement of the user and/or patient.
  • Another object of the present invention is to provide a system for the exchange of brain waves between two or more people or patients, with the purpose of feeding brain information into a shared recovery process, facilitating the transfer of emotionality when the process is carried out. cape.
  • the system includes a portable electroencephalogram sensor device for capturing the person's brain waves, a Smartphone device, TV Stick or extended reality device as a processing unit and gateway between the EEG device and the Internet, and an Artificial Intelligence platform in the cloud, for the management of patient information, brain wave data, Machine Learning (ML) algorithms and presentation of diagnosis and results.
  • a portable electroencephalogram sensor device for capturing the person's brain waves
  • a Smartphone device for capturing the person's brain waves
  • TV Stick or extended reality device as a processing unit and gateway between the EEG device and the Internet
  • an Artificial Intelligence platform in the cloud for the management of patient information, brain wave data, Machine Learning (ML) algorithms and presentation of diagnosis and results.
  • ML Machine Learning
  • the system can alternatively operate from a Smartphone device, TV Stick or Extended Reality Device, in this way the user and/or patient can follow the instructions during the brain measurement and exercises for the management of anxiety and pain.
  • the method of the invention considers the interaction of the user and/or patient in a processing and visualization platform consisting of a 2D, 3D or Extended Reality screen depending on the modality of use and a potable electroencephalogram device, which together provide a method for the diagnosis and/or prognosis of a person's level of anxiety and/or pain based on the non-invasive recording of the power of the EEG bands of the user and/or patient and facilitates a guided relaxation experience.
  • a method and system is provided that, using a portable EEG, facilitates the diagnosis and/or treatment of pain and/or anxiety, through the implementation of one or more Machine Learning (ML) mechanisms, which operate by developing a correlation between the Patient's self-assessed pain and/or anxiety level using a visual (analogue) scale and the power of the measured EEG bands (portable EEG).
  • ML Machine Learning
  • the pain and/or anxiety detection system is fed by the EEG signals obtained (power of the EEG bands) and the self-assessed levels of pain and/or anxiety and implements a classification or detection of patterns for the diagnosis of pain and/or anxiety. or anxiety without requiring additional information from the user or patient. It is possible to implement the EEG method, system and device to obtain a pain level based on an online measurement, a result that can be provided to the user and/or patient, specialist, treater, or health service provider.
  • the online pain and/or anxiety assessment can be used for continuous pain monitoring of a user and/or patient and suggest one or more relaxation exercises using the user interface available whether Smartphone, TV Stick or Reality Device. Extended, to reduce the perception of pain and avoid unnecessary medications.
  • the information on brain waves, level of attention and level of relaxation of the individual during their relaxation exercise is processed online by the cloud platform, and simultaneously depending on the levels that are recorded, changes are developed over time. real in the content viewed by the user, with the aim of producing a deeper state of relaxation.
  • the data collected is intended to be stored, analyzed, processed and presented to the specialist or treater in metric graphic form on a clinical cloud platform (Cloud), where the health service provider can visualize the patient's individual indicators by area, and gives the patient cloud access where they can confidentially and securely consult their anxiety and/or pain levels, track their progress in the intervention program for the management of the anxiety and/or pain and receive feedback from specialists.
  • Cloud clinical cloud platform
  • Access to the cloud platform is provided to the treatment or therapist so that they can track the anxiety and/or pain levels of the user or patient, develop monitoring of an area or, if necessary, carry out a detailed review of the brain data of a patient from the patient record provided by the system.
  • each session is composed of baseline measures of brain activity (Block M), and intervention with relationship exercises and breathing techniques ( Block I) .
  • Block M baseline measures of brain activity
  • Block I intervention with relationship exercises and breathing techniques
  • a session on the platform is made up of a first M Block, I Blocks in an amount suggested by the platform and a final M block.
  • the session begins with the user and/or patient answering a pain and/or anxiety scale (visual analogue), and then the system acquires a first basal measurement of brain activity (using EEG) this is called in the system as a Block. M.
  • a pain and/or anxiety scale visual analogue
  • Block M the user and/or patient will receive a list of relaxation exercises recommended by the Artificial Intelligence system, based on the level obtained on the scales and the result of the basal measurement with EEG. Likewise, the system also considers information from past measurements and results.
  • the Relaxation Block or Block I provides techniques for the management and prevention of anxiety and pain.
  • a session in the system must incorporate at least one initial M Block, followed by a number of I Blocks suggested by the platform and a final M Block.
  • a list of available exercises will be specified, each one representing a challenge for the user and/or patient, which must be completed during their intervention (Block I).
  • a real-time relaxation and attention indicator quantifies the ability to find an internal state of full attention, which allows users to learn to self-manage their anxiety and/or pain, facilitating internal balance.
  • this indicator is used to create audible signals and control movement over objects or animals that influence reflection.
  • Block I incorporates breathing practices and guided meditation; where the user and/or patient will view from the selected 2D or 3D device, a relaxation and/or learning experience with a guide in its digital format (Avatar), in a relaxing environment.
  • the relaxation experience operates by promoting changes in the measured EEG power levels of the different brain waves and specifically those related to anxiety and pain (Alpha, Beta and Theta). It is possible to visualize the magnitude of the changes in the Cloud Platform, which provides graphs that represent the different levels of EEG power of the user and/or patient for the different intervention blocks, as described in Figures 3 and 4 for two respective I blocks (before and after relaxation).
  • the exercise environment is presented to the user through the available display alternatives.
  • the environment may include 3D simulations, audio, objects, 360-degree images/video, and 2D landscapes corresponding to the current environment.
  • the Block I exercise incorporates the facility for the user and/or patient to receive rewards for achieving objectives during their exercises; given the increase in power of the Theta and Alpha bands and the reduction in Beta power, for example.
  • Visual or auditory rewards related to real-time changes in brain waves are alerted to the user in real time for their gratification and take the form of scores and medals in their user profile in the cloud.
  • the invention comprises a system composed of a portable electroencephalogram (EEG) device for measuring brain waves and neural feedback (Neurofeedback) (400), a processing and display device Smartphone or Tablet PC (430) and/or TV Stick (420) and/or Extended Reality Device (410), and a cloud-based diagnostic and monitoring platform based on artificial intelligence (300), which correlates with; a measurement method for quantifying the level of anxiety and pain in users and/or patients, with an intervention, for the management of anxiety and pain, and limited to a non-finite number of sessions, allows optimizing the effectiveness of the treatment, reducing drug doses and analgesia reduce side effects and potential adverse reactions.
  • EEG portable electroencephalogram
  • the system comprises a 2D or 3D user interface, with which the user and/or patient interacts, a diagnostic mechanism using electroencephalogram, and an intervention that provides a guided relaxation experience and that allows the user and/or The patient develops the skills to confront anxiety and pain symptoms based on recommendations derived from an artificial intelligence system supervised by a specialist.
  • An EEG sensor (400) is fixed on the forehead of the user and/or patient (dry electrode), allows the recording of brain waves in Block M, and also allows neural feedback (Neurofeedback) within the relaxation and management experience. anxiety and pain Block I.
  • the M Block brain wave capture allows the recording, storage and processing of Delta, Theta, LowAlpha, HighAlpha, LowBeta, HighBeta, LowGama, HighGama brainwave data on the cloud platform (300).
  • the end user device is responsible for integrating with the EEG via Bluetooth and writing the brain data to the cloud.
  • Content with cognitive restructuring components (350) is provided to the user and/or patient through of the visualization media available, for the learning and development of relaxation and breathing techniques leading to the adoption of new tools for the management of anxiety and/or pain.
  • the system also comprises a cloud platform that centrally controls the user and/or patient devices (300), their content, manages the licenses for use of the system and method of the invention, records user and/or patient information, stores and processes the information of the user's physiological variables (EEG, or others), facilitating the improvement of the content and its real-time adjustment as the user views it.
  • the platform or software in the cloud manages the visual content that is presented graphically on the display devices, sounds (music or voice user guidance) and, on the other hand, concentrates the neural feedback data (Neurofeedback) generated. by the EEG sensor that is available to the user, making it easier for Artificial Intelligence algorithms to develop recommendations that facilitate an improvement in the diagnosis and experience.
  • high-speed data ingestion is generated for the aggregation and storage of data (340) in real time, application of intelligence algorithms artificial (310), supervised training and learning (320), predictive module (330), therapeutic content management (350), presentation and integrations (360) and supervision by specialists (380).
  • the system comprises a calculation and learning engine based on artificial intelligence (310), which, based on brain wave information, analog pain and anxiety rating scales and artificial intelligence (machine learning), allows the prediction of the chronic pain event. exacerbated prior to its manifestation.
  • artificial intelligence 310
  • machine learning artificial intelligence
  • the system of the invention integrates analog and digital means to measure and detect the anxiety and pain levels of the user and/or patient before, during and after the session.
  • the analog characteristic of the measurement will be provided through visual scales or inventories, which the user and/or patient completes when accessing the cloud platform or at the beginning of a measurement (Block M alone) or session.
  • the digital characteristic of the measurement is provided by the EEG device that reads and records the user's brain waves, with which it is possible to make an initial estimate, during the exercise and at the end of it or in isolation to only establish the baseline of anxiety and pain.
  • the immersion will incorporate related feedback, such as smells and other inputs such as, for example, wind generated by a fan to increase the user's immersion in the simulation, while the optional interaction with The facilitator will be provided to assist the user with any concerns related to the use of the system.
  • the sound, background video and generated voice guidance are centrally controlled through the cloud platform (PC).
  • PC cloud platform
  • the user at any time during the journey may have access to a help or assistance button to obtain immediate feedback from the facilitator or stop the simulation.

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Abstract

La présente invention concerne un système et une méthode pour le diagnostic et la gestion de l'anxiété et/ou de la douleur sans avoir recours à des médicaments, ledit système au moyen d'un capteur d'électroencéphalogramme portable (EEG) connecté à un dispositif de traitement, un téléphone intelligent/une clé HDMI ou une lentille de réalité augmentée et une plate-forme d'intelligence artificielle sur le nuage (Cloud) permettant le diagnostic et le suivi de l'anxiété et de la douleur d'une personne et développant, en plus, une intervention pour la gestion de ces niveaux, par introduction de la personne dans un environnement de stimulation numérique 2D dans le cas d'un téléphone intelligent/d'une TV ou d'un environnement 3D (réalité virtuelle ou augmentée), ce qui fournit les outils de diminution de l'anxiété et de gestion de la douleur.
PCT/CL2022/050089 2022-09-07 2022-09-07 Système pour le diagnostic et la gestion de l'anxiété ou de la douleur WO2024050650A1 (fr)

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014151874A1 (fr) * 2013-03-14 2014-09-25 Accendowave Incorporated Systèmes, méthodes et dispositifs pour évaluer et traiter la douleur, la gêne et l'anxiété
US20150351655A1 (en) * 2013-01-08 2015-12-10 Interaxon Inc. Adaptive brain training computer system and method
US20170071495A1 (en) * 2013-04-22 2017-03-16 Personal Neuro Devices Inc. Methods and devices for brain activity monitoring supporting mental state development and training
US10092206B2 (en) * 2012-12-07 2018-10-09 Rivka SELA Neurofeedback treatment system and method
US20220323766A1 (en) * 2020-12-31 2022-10-13 Advanced Neuromodulation Systems, Inc. Systems and methods for providing neurostimulation therapy according to machine learning operations

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10092206B2 (en) * 2012-12-07 2018-10-09 Rivka SELA Neurofeedback treatment system and method
US20150351655A1 (en) * 2013-01-08 2015-12-10 Interaxon Inc. Adaptive brain training computer system and method
WO2014151874A1 (fr) * 2013-03-14 2014-09-25 Accendowave Incorporated Systèmes, méthodes et dispositifs pour évaluer et traiter la douleur, la gêne et l'anxiété
US20170071495A1 (en) * 2013-04-22 2017-03-16 Personal Neuro Devices Inc. Methods and devices for brain activity monitoring supporting mental state development and training
US20220323766A1 (en) * 2020-12-31 2022-10-13 Advanced Neuromodulation Systems, Inc. Systems and methods for providing neurostimulation therapy according to machine learning operations

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