ES2994763A1 - HYPERBARIC MAGNETIC NEUROSTIMULATION METHOD AND SYSTEM WITH CUSTOMIZABLE SEMI-AUTOMATIC PARAMETRIC ADJUSTMENT (Machine-translation by Google Translate, not legally binding) - Google Patents

Abstract

Hyperbaric magnetic neurostimulation method and system with customizable semi-automatic parametric adjustment. The system consists of a hermetically sealed cylinder designed to create an environment in which pressures higher than normal atmospheric pressure can be generated and oxygen can be administered at various concentrations. The chamber is built with conductive materials and with electrical continuity to guarantee electromagnetic isolation inside it during hyperbaric neurostimulation treatment (Faraday cage). The cylinder has a transparent window to avoid the sensation of claustrophobia inside it. The system is divided into three modules, all of them contained in the cylinder: A) Transcranial magnetic stimulation module comprising a current generating device to energize the inductor coils and an applicator device containing the coils, which can be connected independently to stimulate different areas of the brain; and electrodes for recording brain electrical activity, B) Hyperbaric oxygen therapy module, C) Control and monitoring module for customizable semi-automatic parametric adjustment comprising a set of biometric sensors, inertial sensors, pneumatic actuators for generating somatosensory potentials and an embedded computer system to perform the customizable automatic parametric adjustment method. The method of the present invention stimulates and records simultaneously to characterize the symptoms associated with various neurological disorders, then generates a signal for transcranial magnetic stimulation of fixed amplitude and variable frequency. It performs a frequency sweep until some characteristic of the symptoms is modified, it is said that neuromodulation has occurred. These parameters are stored in a database where the frequency found is assigned to the patient, making the therapeutic system customizable. (Machine-translation by Google Translate, not legally binding)

Description

HYPERBARIC MAGNETIC NEUROSTIMULATION METHOD AND SYSTEM WITH

CUSTOMIZABLE SEMI-AUTOMATIC PARAMETRIC ADJUSTMENT

TECHNICAL SECTOR

The invention relates to the field of neuromodulation devices using transcranial magnetic stimulation, to oxygen therapy devices in hyperbaric chambers; and to biomedical signal recording devices and inertial sensors for customizable semi-automatic parametric adjustment. More specifically, it relates to a method and system for magnetic neuromodulation and hyperbaric oxygenation with customizable semi-automatic parametric adjustment for the therapeutic treatment of some neurological disorders.

BACKGROUND OF THE INVENTION

Neurological disorders and their consequences are estimated to affect one billion people worldwide today. According to the World Health Organization (WHO), neurological disorders are diseases of the central and peripheral nervous system. That is, of the brain, spinal cord, cranial and peripheral nerves, nerve roots, autonomic nervous system, neuromuscular plate and muscles. These disorders include migraines, headaches, certain depressive conditions, some nervous system sensitization syndromes such as fibromyalgia, some sleep disorders such as insomnia, disorders that include alterations in muscle response such as parkinsonism and tremors; among others.

Although there is currently no known cure for some of these neurological disorders, there are a variety of treatments that help treat and relieve their symptoms, including alternative treatment options such as neuromodulation using transcranial magnetic stimulation and hyperbaric oxygen therapy. Modulation of brain activity or neuromodulation is carried out by means of a stimulus (preferably noninvasive) that modifies one or more of the characteristics of the brain's electrical signals. This stimulus may or may not be in phase with the brain's electrical signals, which requires a recording system for system feedback. Magnetic neuromodulation uses very low intensity magnetic fields to stimulate specific areas of the brain. On the other hand, hyperbaric oxygen therapy involves the inhalation of oxygen in a high-pressure atmosphere, improving oxygenation that facilitates neovascularization and the reduction of tissue inflammation. Recently, it has been shown that increasing oxygen concentration in the brain causes changes in brain metabolism and glial function, and can reduce abnormal brain activities associated with various neurological disorders.

US Patent 11,583,690, B2 describes a therapeutic system consisting of a cylindrical chamber comprising a hyperbaric chamber, an LED array and inductive coil rings. The patent describes the benefits and applications of applicable hyperbaric chamber therapies such as oxygen therapy and ozone therapy. As for the inductive coil rings, the use of magnetic stimulation is mentioned mainly for tissue regeneration. Finally, the use of the LED array is indicated for analgesic purposes in specific areas of the body according to the patent description.

Utility model ES1068435 (U) describes a single-seat hyperbaric chamber system characterized by having a removable stretcher for the user's operating comfort.

Regarding neuromodulation systems using magnetic fields, patent ES2293778 describes a low-intensity transcranial stimulator that generates various waveforms digitally, being able to control its parameters (frequency and amplitude) with greater precision than its analog counterpart.

Patent ES2325936 describes a simultaneous electroencephalographic recording system during low-intensity transcranial magnetic stimulation, which consists of a double helmet: one that includes a set of electrodes for monitoring brain electrical activity and another superimposed one that includes a set of conductive coils for generating the low-intensity magnetic field. In this invention, the stimulation and recording systems are independent, so it is necessary to feed the recording system back with the stimulation signal for subsequent processing.

The alteration of the somatosensory response is a significant symptom in several neurological disorders, the recording of brain activity during somatosensory stimulation (generation of evoked potentials) is a biomarker indicated to measure the effect of magnetic neuromodulation for therapeutic purposes. Patents ES2317817 (B2) and ES2316331 (B2) describe a somatosensory pneumatic system that allows the study of brain activity from the responses produced to the incident stimulus. Both devices are based on the extension-retraction movement carried out by a piston controlled by pneumatic pressure, adapted to specific points of the human anatomy.

Various neurological disorders have, among their symptoms, alterations in muscular response that can be recorded by means of inertial sensors. Patent CN109480858A describes a portable intelligent system and method for detecting symptoms of bradykinesia in patients suffering from Parkinson's disease in a quantified manner. This system consists of various inertial sensors for detecting movement in the patient's joints.

Another symptom of some neurological disorders is the modification or alteration of the phases of the sleep cycle. Among these alterations, it may occur that one of the phases is not present or shows alterations in its characteristic pattern. Transcranial magnetic stimulation can induce, modify or alter any of the phases of the sleep cycle. Patent ES2712062 (T3) describes a method and a system to control a therapy based on the state of sleep that uses implantable electrodes to electrically stimulate at the neuronal level and a recording electrode to detect the neuronal activity of the brain and adjust the stimulation parameters depending on the signal collected.

The present invention differs from various magnetic stimulation devices, which may or may not employ a hyperbaric chamber for simultaneous oxygen therapy treatment, in that it has a series of pneumatic actuators and biometric sensors (compatible with magnetic stimulation) for the generation and recording of somatosensory evoked potentials that enables automatic parametric adjustment for the treatment of some neurological disorders. In addition, the present invention records alterations in: the muscular response and in the cerebral electrical activity of the various phases of the sleep cycle for the same purpose. With the use of hyperbaric oxygen therapy, changes in cerebral metabolism and glial function are stimulated, and abnormal cerebral activities associated with various neurological disorders are reduced.

Unlike patent ES2712062 (T3), the system and method of the proposed invention uses low-intensity magnetic fields, instead of electric currents, which can be supplied independently in each of the stimulation coils placed in various anatomical areas of the brain and which have specific mechanisms for the generation of somatosensory evoked potentials.

US patent 2013/0281759 A1 describes a device and a method for transcranial stimulation based on electrophysiological tests. It proposes simultaneous electroencephalographic recording with noninvasive stimulation that can be transcranial electrical or magnetic stimulation or visual, auditory or balance stimulation using glasses and hearing aids to deliver the stimulus. The method and device have their application in localizing mild traumatic brain injuries and age-related cognitive impairments. The patent of the present invention has its application in neurological disorders that do not have to be associated with brain injuries or the age of the patient. In addition, to determine the characteristics of the symptoms associated with these neurological disorders, biometric sensors and inertial sensors are used, which are not discussed in the present invention. The generation of somatosensory stimuli is through pneumatic actuators that can adjust the pressure individually to produce the measurable evoked potential threshold, while the present invention uses a system of glasses and hearing aids. Finally, changes in brain metabolism and glial function are stimulated, and abnormal brain activities associated with various neurological disorders are reduced by simultaneous hyperbaric oxygenation therapy. All of the above allows for a customizable, automatic parametric adjustment neuromodulation system and method thanks to the database containing various protocols and therapeutic information of patients implemented and managed by the computer system of the present invention.

DESCRIPTION OF THE INVENTION

The present invention relates to a method and a hyperbaric magnetic neuromodulation system with semi-automatic and customizable parametric adjustment for the therapeutic treatment of various neurological disorders.

The system consists of a hermetically sealed cylinder designed to create an environment in which pressures higher than normal atmospheric pressure can be generated and oxygen can be administered at various concentrations, which stimulates changes in brain metabolism and glial function, and reduces abnormal brain activities associated with various neurological disorders. The cylinder is large enough to comfortably accommodate a person lying inside on a stretcher made of non-conductive material, which is removable for the user's comfort. The chamber is constructed of conductive materials and with electrical continuity to ensure electromagnetic isolation inside it during hyperbaric neurostimulation treatment (Faraday cage). The cylinder has a transparent window to avoid the sensation of claustrophobia inside it. The window must contain conductive materials in its construction and be covered with a laminate of conductive material to maintain the electrical continuity of the cylinder. The system is divided into three modules, all contained in the cylinder: A) Transcranial magnetic stimulation module, B) Hyperbaric oxygen therapy module, C) Control and monitoring module for customizable semi-automatic parametric adjustment.

A) Low-intensity transcranial magnetic stimulation module

Neuromodulation for therapeutic purposes in various neurological disorders is achieved through low-intensity transcranial magnetic stimulation, which modifies one or more of the characteristics of the brain's electrical signals. This stimulus may or may not be in phase with these electrical signals and may be applied to specific areas of the brain.

This module consists of two devices:

- Generator device: consisting of a digital stage for generating the various waveforms of the stimulating signal from the parameters sent from the control and monitoring unit (signal amplitude, frequency and phase); a digital/analogue conversion stage to transform the digital data into a voltage signal; and a voltage-to-current conversion stage to energize the coils and generate by induction the low-intensity magnetic field for neuromodulation.

- Neuromodulation helmet and simultaneous monitoring of brain electrical activity (applicator device): The helmet has an ergonomic design that allows for a comfortable and safe fit to the patient. It contains coils made of conductive material that, through the principle of induction, generate low-intensity magnetic fields that penetrate the brain tissue and allow neuromodulation. For greater selectivity of the area of the brain to be stimulated, the coils can be energized individually and independently. Inside the helmet, the induction coils are placed in each of the areas to be stimulated according to the following distribution: two frontal areas, two temporal areas, one occipital area, one parietal area and one cervical area. The connection of the coils to be energized to the generating device is done through a multiplexing system that guarantees that the current circulating in each of them is the same. This system divides the neuromodulation helmet into the various stimulation areas and groups the coils in parallel in each of them. A first digital selector defines the zone or zones to be stimulated and a second selector energizes the coils selected in each zone for transcranial magnetic stimulation. Since all the coils and switching transistors are the same, the generating device must deliver sufficient current, which, when divided equally in each of them, guarantees that the field generated in the stimulation zones is the one specified by the selected protocol or by the medical professional. In addition, the helmet contains recording electrodes for simultaneous monitoring of brain electrical activity (EEG) together with neurostimulation, which allows feedback to the system for customizable automatic parametric adjustment. The placement of the recording electrodes inside the helmet follows the international 10-20 system.

The low-intensity transcranial magnetic stimulation module has communication with the control and monitoring module for customizable semi-automatic parametric adjustment.

B) Hyperbaric oxygen therapy module

The cylinder of the present invention has a hermetic seal designed to create an environment in which oxygen can be administered at pressures higher than normal atmospheric pressure. The hyperbaric oxygen therapy module contains a set of pressure gauges to control the pressure, valves to carry out the compression and decompression processes, an oxygen recirculator and an intercom to maintain communication with the patient. In addition, this module has accessories for safety and control such as a safety valve, a thermometer and the exhaust system for stale air or the end-of-session system.

The hyperbaric oxygen therapy module has communication with the control and monitoring module for customizable semi-automatic parametric adjustment.

C) Control and monitoring module for customizable semi-automatic parametric adjustment

The most important parameters of hyperbaric magnetic neuromodulation (there may be more depending on the therapy) to monitor are the following:

- In low-field transcranial magnetic stimulation: waveform, frequency, phase and amplitude of the stimulating signal; and area of the brain to be stimulated, defining which induction coils should be energized (focused stimulation).

- In hyperbaric oxygen therapy: pressure and concentration of oxygen in the cylinder.

These parameters can be entered manually by the medical professional or can be automatically adjusted by this module.

For automatic parametric adjustment, the module has a set of sensors:

- Brain electrical activity sensors: recording electrodes inside the neuromodulation helmet and electroencephalogram (EEG) monitoring.

- Cardiac electrical activity sensors: recording electrodes for monitoring electrocardiogram (ECG).

- Muscle electrical activity sensors: recording electrodes for monitoring electromyogram in various parts of the body (EMG).

- Motion sensors: inertial sensors for monitoring the movement of various parts of the body.

- Oximetry sensors for monitoring patient oxygenation.

This module also contains a set of pneumatic actuators for somatosensory stimulation (evoked potentials) since in some neurological disorders there is an alteration in the brain's response to these stimuli. This stimulation is based on the extension-retraction movement carried out by a piston adapted to specific points of the human anatomy. The evoked potentials generated by this means are collected in the recording electrodes inside the neuromodulation and monitoring helmet of the transcranial magnetic stimulation (EEG) module and are used as biomarkers to measure the effect of neuromodulation and allow automatic parametric adjustment.

The set of pneumatic actuators and biometric and inertial sensors can be integrated into one or more neurosensory stimulation and biomedical and inertial signal recording devices.

The module also has an embedded computer system (software and hardware) to collect signals from biometric and inertial sensors:

- the electrical activity of the brain (electroencephalogram, EEG).

- muscular electrical activity (myoelectric signals, EMG).

- cardiac electrical activity (electrocardiogram, ECG).

- the detection of the various phases of the sleep cycle (polysomnographic study).

- alterations in muscular response.

- the patient's blood oxygen level.

The embedded computer system also performs other functions:

- controls pneumatic actuators for somatosensory stimulation (generation of evoked potentials).

- controls the serial multiplexing system of the inductor coils inside the neuromodulation and monitoring helmet for the generation of magnetic fields.

- performs automatic parametric adjustment for hyperbaric magnetic neuromodulation using the signals collected by the biometric sensors (some of them generated with the pneumatic actuators) and by the inertial sensors.

- manages alarms and warning signals for the entire system.

In addition to the above, the embedded computer system manages a database containing the standardized protocols of hyperbaric magnetic neurostimulation:

- Waveforms, frequency range and amplitude range of the signals applicable for magnetic stimulation therapy.

- Areas of the brain to be stimulated by defining the number of inductor coils to be energized

- Atmospheric pressure and oxygen concentration inside the cylinder for hyperbaric oxygen therapy.

Standardized protocols are classified according to the symptoms of the neurological disorder to be treated, which may be as follows (there may be other classifications):

- Neurological disorders with symptoms associated with altered neuronal response to somatosensory stimuli.

- Neurological disorders with symptoms associated with alterations in muscular response.

- Neurological disorders with symptoms associated with alterations in one or more phases of the sleep cycle.

The database also stores the configurations (parametric data) of each patient's therapeutic sessions to reduce the time of automatic parametric adjustment, making it a customizable system.

Within the same database there are also standardized protocols that are manually adjusted with the patient's clinical information. The neurological disorders included in this group are:

- Headaches

- Some types of depression

The embedded computer system has a user interface for:

- the entry of data into the system relating to the therapeutic session such as: name, age and gender of the patient, type of neuronal disorder, hyperbaric magnetic neuromodulation protocol, duration of the session, etc.

- monitoring system for all data relating to the therapeutic session.

- alarm system malfunction or incorrect operation.

- Internet connection for remote control of the system and with all security mechanisms implemented to guarantee patient safety and data protection protocol.

The present invention also proposes a method for hyperbaric magnetic neuromodulation with semi-automatic parametric adjustment. Said method may comprise the following phases (this is only an example of implementation and not all phases are essential and indispensable for the method to be carried out):

- A selection phase of the standardized protocol for hyperbaric magnetic neuromodulation that is manually entered from the interface of the Control and Monitoring Module for customizable semi-automatic parametric adjustment according to the symptoms associated with the alteration of: a) the neuronal response to somatosensory stimuli, b) the muscular response, c) the quality of sleep

- A semi-automatic parametric adjustment phase: the parameters of hyperbaric magnetic neuromodulation can be entered in three ways: manually using the parameters prescribed by the medical professional, manually or automatically using the data from the selected protocol from the database.

Automatic parametric adjustment is done in various stages depending on the symptoms associated with the neurological disorder:

Pulmonary disorders with symptoms associated with altered neuronal response to somatosensory stimuli

- Measurable detection stage of the evoked potential: the computer system of the Control Module generates a ramp-type signal to be sent to one or more of the pneumatic actuators located anatomically in the patient. Ramp-type mechanical stimulation is a train of increasing pulses that allows different pressures to be applied to the piston; the parameters to be chosen are pulse duration and interval between pulses. In each of the previous pulses, the mechanical actuator is activated and retracted, generating an evoked potential in one or more of the selected anatomical points of the patient. The execution of the process stops automatically when the evoked potential is recorded in the brain by one or a set of electrodes located in the applicator device (neuromodulation and monitoring helmet) of the magnetic stimulator. That is, when the electroencephalogram records the brain activity associated with somatosensory stimulation. The execution of the process can also be interrupted when the patient activates an emergency button if he considers that there is an excessively intense somatosensory response. The pressure parameter on the pneumatic actuator that generates a measurable evoked potential (measurable somatosensory potential threshold) is stored by the system for the next stage of the process.

- Frequency search stage for transcranial magnetic stimulation: the embedded computer system sends the signal for the generation of potentials evoked by the actuators placed at one or more anatomical points of the patient using the pressure parameter of the measurable somatosensory potential threshold. Simultaneously, the signal for transcranial magnetic stimulation of fixed amplitude and variable frequency is sent. The method performs a frequency sweep until the measurable somatosensory potential threshold is modified in one of its characteristics, neuromodulation occurs.

Neurological disorders with symptoms associated with altered muscle response.

-Stage of detection of alterations in the muscular response and its characteristics: the embedded computer system of the control system records the alteration in the patient's muscular response with the inertial sensors and with the myoelectric signal recorded by the electrodes to perform a characteristic parameterization.

- Frequency search stage for transcranial magnetic stimulation: the embedded computer system sends the signal for transcranial magnetic stimulation with a fixed amplitude and variable frequency. The method performs a frequency sweep until one of the characteristic parameters of the alteration of the muscular response is modified, neuromodulation occurs.

Neurological disorders with symptoms associated with sleep quality

- Sleep quality determination stage: the embedded computer system of the control system records, using the electroencephalogram and other biometric sensors (polysomnography), the presence or absence of the various phases of the sleep cycle and performs a characteristic parameterization of each of them.

- Frequency search stage for transcranial magnetic stimulation: the embedded computer system sends the signal for transcranial magnetic stimulation of variable amplitude and frequency. The method performs a frequency sweep until one of the characteristic parameters of the various phases of the sleep cycle is modified, neuromodulation occurs.

The frequency found at this stage is stored in the database and assigned to the patient who manages the Control and Monitoring Module for customizable semi-automatic parametric adjustment.

The frequency of the magnetic stimulation signal is one of the parameters to be adjusted using the method proposed in the present invention, but it may be the case that, once the frequency has been found, the same method is applied to determine the amplitude and phase that produce the neuromodulation.

DESCRIPTION OF THE FIGURES

As an integral part of this description, drawings are attached, which, for illustrative and non-limiting purposes, represent:

Figure 1: Complete hyperbaric magnetic neurostimulation system with customizable semi-automatic parametric adjustment that includes: A) Transcranial magnetic stimulation module, B) Hyperbaric oxygen therapy module, C) Control and monitoring module for customizable semi-automatic parametric adjustment.

Figure 2: Location of coils based on the 10-20 electroencephalogram system and independent zones of transcranial magnetic stimulation.

Figure 3: Multiplexing system for the independent connection of coils connected in parallel in each of the zones to be stimulated. Multiplexing by means of digital switches that connect one or more coils of each of the zones to be stimulated to the output and input of the current generating device.

Figure 4: Comprehensive device for neurosensory stimulation and recording of biomedical and inertial signals.

PREFERRED EMBODIMENT OF THE INVENTION

Figure 1 shows the hyperbaric magnetic neurostimulation system with customizable semi-automatic parametric adjustment, consisting of a cylinder made of conductive material (Faraday cage behavior) with a hermetic seal (1) that allows generating pressures higher than normal atmospheric pressure and administering oxygen at various concentrations. The dimensions of the cylinder allow a person to lie down inside it on a removable stretcher made of non-conductive material (2). The cylinder has a transparent window, which prevents the sensation of claustrophobia inside it, built with a conductive material and covered with a laminate, also made of conductive material, which guarantees electrical continuity on the surface of the cylinder (3).

The system of the present invention consists of 3 modules:

Low intensity transcranial magnetic stimulation module (4) consisting of: - A generating device (5) consisting of a digital stage for the generation of the various waveforms with their respective parameters (amplitude, frequency and phase) of the stimulating signal, a digital/analog conversion stage to transform the digital data into a voltage signal; and a voltage to current conversion stage to energize the coils and generate by induction the low intensity magnetic field for neuromodulation.

- A helmet for neuromodulation and simultaneous monitoring of brain electrical activity (applicator device) with an ergonomic design that allows a comfortable and safe fit to the patient (6). The coils are located inside the helmet following the 10-20 distribution of the international EEG system (11). The distribution is divided into: two frontal zones (12, 13), two temporal zones (14, 15), an occipital zone (16), a parietal zone (17) and a cervical zone (18). Each of the induction coils can be energized independently allowing the focusing of transcranial magnetic stimulation. The connection of the coils (20) to the current generating device is done through a multiplexing system (19) that guarantees that the current that circulates through each of the coils is the same and that the induced field will be the same in each of them (19). The multiplexing system (19) consists of two sets of digital switches: one to select the area of the brain to be stimulated (21) and another to select the number of coils to be energized within the chosen area (22). For monitoring of brain electrical activity (EEG), the helmet contains recording electrodes which allow feedback to the system for customizable automatic parametric adjustment.

Hyperbaric oxygen therapy module (7) containing a set of manometers to control the pressure, valves to perform the compression and decompression processes; and an oxygen recirculator.

Control and monitoring module for customizable semi-automatic parametric adjustment (8) that has a set of sensors:

- Cardiac and muscle electrical activity sensors: recording electrodes for monitoring the electrocardiogram and electromyogram in various parts of the body (24).

- Motion sensors: inertial sensors for monitoring patient movements, muscle response (25).

- Oximetry sensors for monitoring oxygenation in the patient (26).

This module also contains a set of pneumatic actuators (27) for somatosensory stimulation (evoked potentials) based on the extension-retraction movement performed by a piston adapted to specific points of the human anatomy.

The set of pneumatic actuators and biometric and inertial sensors can be integrated into a device for somatosensory stimulation and recording of biomedical and inertial signals(23).

This module also features an embedded computer system (9) with a user interface (10) for:

- the entry of data into the system relating to the therapeutic session such as: name, age and gender of the patient, type of neuronal disorder, hyperbaric magnetic neuromodulation protocol, duration of the session, etc.

- monitoring system for all data relating to the therapeutic session.

- alarm system malfunction or incorrect operation.

- Internet connection for remote control of the system and with all security mechanisms implemented to guarantee patient safety and data protection protocol.

The operation of the hyperbaric magnetic neuromodulation system with customizable semi-automatic parametric adjustment comprises several phases (this is only an example of implementation and not all phases are essential and indispensable for the method to be carried out):

- A selection phase of the standardized protocol for hyperbaric magnetic neuromodulation that is manually entered from the interface of the Control and Monitoring Module for customizable semi-automatic parametric adjustment (10) according to the symptoms associated with the alteration of: a) the neuron response to somatosensory stimuli, b) the muscular response, and c) the quality of sleep.

In addition to the above protocols, there are clinical adjustment protocols by the medical professional (manual adjustment) such as: d) headaches, and e) some types of depression of neurological origin.

- A semi-automatic parametric adjustment phase: the parameters of hyperbaric magnetic neuromodulation can be entered in three ways: manually using the clinical parameters prescribed by the medical professional, manually or automatically using the data from the protocol selected from the database.

Automatic parametric adjustment is done in various stages depending on the symptoms associated with the neurological disorder:

Neurological disorders with symptoms associated with altered neuronal response to somatosensory stimuli

- Measurable detection stage of the evoked potential: the computer system of the Control Module (10) generates a ramp-type signal to be sent to one or more of the pneumatic actuators (27) located anatomically in the patient. The ramp-type mechanical stimulation is a train of increasing pulses that allows different pressures to be applied to the piston, the parameters to be chosen are pulse duration and interval between pulses. In each of the previous pulses, the pneumatic actuator (27) is activated and retracted generating an evoked potential in one or more of the selected anatomical points of the patient. The execution of the process stops automatically when the evoked potential is recorded by one or a set of electrodes located in the application device (neuromodulation and monitoring helmet) of the magnetic stimulator (6). That is, when the electroencephalogram records the brain activity associated with somatosensory stimulation. The execution of the process can also be interrupted when the patient activates an emergency button if he/she considers that there is an excessively intense somatosensory response. The pressure parameter in the pneumatic actuator that generates a measurable evoked potential (measurable somatosensory potential threshold) is saved by the computer system (10) to be used in the next stage of the process.

- Signal frequency search stage for transcranial magnetic stimulation: the embedded computer system sends the signal for the generation of the potentials evoked by the actuators (27) placed at one or more anatomical points of the patient using the pressure parameter of the measurable somatosensory potential threshold. Simultaneously, the signal for transcranial magnetic stimulation of fixed amplitude and variable frequency (4) is sent. The method performs a frequency sweep until the measurable somatosensory potential threshold is modified, neuromodulation occurs.

Pulmonary disorders with symptoms associated with altered muscle response

- Stage of detection of alterations in the muscular response and its characteristics: the embedded computer system (10) of the control system records the alteration of the patient's muscular response with the inertial sensors (25) and with the myoelectric signal recorded by the electrodes (24) to perform a characteristic parameterization.

- Frequency search stage for transcranial magnetic stimulation: the embedded computer system (10) sends the signal for transcranial magnetic stimulation with a fixed amplitude and variable frequency (4). The method performs a frequency sweep until one of the characteristic parameters of the alteration of the muscular response is modified, neuromodulation occurs.

Neurological disorders with symptoms associated with sleep quality

- Sleep quality determination stage: the embedded computer system of the control system records, using the electroencephalogram (4) and other biometric sensors (polysomnography (24-26)), the quality of sleep by analyzing the presence or absence of the various phases of the sleep cycle and performs a characteristic parameterization of each of them.

- Frequency search stage for transcranial magnetic stimulation: the embedded computer system (10) sends the signal for variable amplitude and frequency transcranial magnetic stimulation (4). The method performs a frequency sweep until one of the characteristic parameters of the various phases of the sleep cycle is modified, neuromodulation occurs.

The frequency found at this stage is assigned to the patient and stored in the database managed by the Control and Monitoring Module for personalized semi-automatic parametric adjustment (9).

The frequency of the magnetic stimulation signal is one of the parameters to be adjusted using the method proposed in the present invention, but it may be the case that, once the frequency has been found, the same method is applied to determine the amplitude and phase that produce the neuromodulation.

Although the present invention has been described with reference to specific embodiments, it should be understood by those skilled in the art that the foregoing and various other changes, omissions and additions in form and detail thereof may be made without departing from the scope of the invention as defined by the following claims.

Claims (9)

1. Hyperbaric magnetic neurostimulation system with customizable semi-automatic parametric adjustment consisting of a cylinder of conductive material (Faraday cage behavior) with hermetic closure (1) comprising three modules: - Low intensity transcranial magnetic stimulation module (4) consisting of: or at least one digital-analog device for generating the electric current that energizes the coils (20) for generating the magnetic field by induction (5). or at least one helmet for neuromodulation and simultaneous monitoring of brain electrical activity (6) containing a set of inductor coils (20) and a set of electrodes for recording brain electrical activity. or at least one digital multiplexing system (19) to independently energize each of the coils contained in the neuromodulation helmet (6). - Hyperbaric oxygen therapy module (7) containing at least one pressure gauge to control the pressure, a valve to perform the compression and decompression processes; and an oxygen recirculator. - Control and monitoring module for customizable automatic parametric adjustment (8) comprising: or one or more biosensors configured to record physiological signals from the patient (24, 26). or one or more inertial sensors to record the patient's muscular response (25). one or more pneumatic actuators (27) to somatosensory stimulate the patient. or at least one embedded computer system (9) with a user interface (10) and configured for: manage a database containing the clinical history of patients and information on therapeutic protocols classified according to the symptoms associated with the alteration of: a) the neuronal response to somatosensory stimuli, b) the muscular response, and c) the quality of sleep. allow manual selection of a therapeutic protocol from those contained in the database. to record and characterize symptoms associated with neurological disorders: somatosensory evoked potentials using EEG, alterations in muscle response using EMG and inertial sensors; and alterations in the various phases of the sleep cycle using polysomnography. ostimulating the brain with magnetic fields, varying the frequency, and simultaneously recording the brain's electrical activity until one of the characteristics of the symptoms associated with neurological disorders is modified, that is, neuromodulation occurs in the patient. or store in the database the frequency found during the automatic parametric adjustment and assign it to the patient's clinical history and the respective protocol in the database. 2. According to claim 1, the cylinder has a transparent window, which prevents the feeling of claustrophobia inside it, constructed of conductive material and covered with a laminate, also of conductive material, which guarantees electrical continuity on the surface of the cylinder (Faraday cage behavior for electromagnetic insulation) (3). 3. Electronic system, according to claim 1, wherein the distribution of the coils contained in the helmet for neuromodulation and simultaneous monitoring of brain electrical activity (6) is based on the international 10-20 system and is divided into various stimulation zones: two frontal zones (12, 13), two temporal zones (14, 15), an occipital zone (16), a parietal zone (17) and a cervical zone (18). 4. Electronic system, according to claims 1 and 3, where each of the induction coils can be energized independently by distribution zones allowing the focusing of transcranial magnetic stimulation. 5. Electronic system, according to claims 1, 3 and 4, comprising a multiplexing system (19) that guarantees that the current flowing through each of the coils and the induced field will be the same in each of them (19). 6. Electronic system, according to claims 1, 3-5, where the multiplexing system (19) comprises two sets of digital switches: one to select the area of the brain to be stimulated (21) and another that selects the number of coils to be energized within the chosen area (22). 7. Electronic system according to claim 1, wherein the set of pneumatic actuators (27) and biometric (24, 26) and inertial (25) sensors are integrated into at least one somatosensory stimulation and biomedical and inertial signal recording device (23). 8. Electronic system according to claim 1, wherein the embedded computer system (9) comprises a user interface (10) for: entering data into the system and monitoring the therapeutic session, managing the malfunction or incorrect operation alarm system; and connecting the system to the Internet for remote control of the system with all security mechanisms implemented to guarantee patient safety and the data protection protocol. 9. Hyperbaric magnetic neurostimulation method with customizable automatic parametric adjustment that includes the following steps according to the symptoms associated with the neurological disorder: Pulmonary disorders with symptoms associated with altered neuronal response to somatosensory stimuli ogenerate a ramp-type signal to be sent to one or more of the pneumatic actuators (27) anatomically located in the patient that through a process of action and retraction produces a somatosensory stimulus. The pressure in the actuator increases until the somatosensory evoked potential is measurable by the recording electrodes in the neuromodulation and monitoring helmet (6), allowing a characterization of it. The pressure parameter in the pneumatic actuator that generates a measurable evoked potential is saved by the computer system (10) to be used later. or generate a somatosensory stimulus (27) using the pressure parameter that generates a measurable evoked potential at the same time that the signal for fixed amplitude and variable frequency transcranial magnetic stimulation is sent (4). or perform a frequency sweep until one of the characteristics of the measurable evoked potential changes. Neurological disorders with symptoms associated with altered muscle response to record and characterize the alteration of the patient's muscular response with the inertial sensors (25) and/or with the myoelectric signal recorded by the electrodes (24). or send the signal for fixed amplitude and variable frequency transcranial magnetic stimulation. or perform a frequency sweep until one of the characteristic parameters of the alteration of the muscular response is modifiedNeurological disorders with symptoms associated with sleep quality to record and characterize, using the recording electrodes in the neuromodulation and monitoring helmet (4); and other biometric sensors (24 26), polysomnography recording, the presence or absence of the various phases of the sleep cycle. or send the signal for variable amplitude and frequency transcranial magnetic stimulation (4). or perform a frequency sweep until one of the characteristic parameters of the various phases of the sleep cycle changes.