Personalized time interference electrical stimulation simulation and control system and method

Abstract

The time interference electrical stimulation simulation and control system comprises a simulation control unit which is used for receiving MR and / or CT brain images to construct an individual brain tissue model, obtaining a secondary parameter set through reverse solution based on the individual brain tissue model and a preliminary parameter set, obtaining a final parameter set through simulation based on the individual brain tissue model and the secondary parameter set, controlling the electrode group to output the stimulation current under the final parameter set; the display is used for displaying the individual brain tissue model, the reverse solution result and the simulation result, and providing an interactive interface of the simulation control unit to adjust the operation of the simulation control unit; and the electrode group is electrically connected with the simulation control unit and is used for receiving the stimulation current under the final parameter set and discharging at a target electrode position. The system provides parameter storage, real-time monitoring and feedback regulation, can realize modeling, simulation and control integrated closed-loop operation, provides high-precision and repeatable TI electrical stimulation, remarkably improves the individual practicability of a TI electrical stimulation treatment scheme, and is suitable for neuroscience research and disease physiotherapy.

Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of biomedical engineering and brain nerve regulation, and particularly relates to a time interference electric stimulation simulation and control system and method. BACKGROUND

[0002] With the rapid development of neuroscience, computer science and biomedical engineering, brain nerve regulation technology has become an important means for studying brain function mechanism and treating nervous system diseases. Among them, time interference (TI) electric stimulation has shown good application prospects in the auxiliary treatment of mental and nervous system diseases such as depression, epilepsy, Parkinson's disease, Alzheimer's disease, etc. by generating a low-frequency interference envelope (hereinafter referred to as beat frequency) stimulation in the deep brain non-invasively. It is also a new experimental tool for researchers to study the working mechanism of the brain nervous system, the regulation of nerve regulation and the relationship between behavior and cognition.

[0003] At present, brain nerve regulation technology is developing from single-point stimulation to multi-modal fusion, individualized modeling and quantitative analysis. In order to further improve the real-time performance, parameter accuracy and repeatability of stimulation, it is urgent to establish a system platform that can integrate brain image data, simulation calculation and stimulation control for integrated research and experimental system, but the existing platform cannot meet the above needs, for example, there may be problems such as lack of individualized electric stimulation model construction for operators, inaccurate dynamic description of electric stimulation grid simulation algorithm, etc.

[0004] Therefore, a TI electric stimulation system with operator individual difference adaptation, electrode configuration and current parameter automatic optimization and simulation optimization is needed. SUMMARY

[0005] In order to solve the problems in the prior art, the purpose of the present application is to provide a time interference electric stimulation simulation and control system, which includes an image data acquisition unit, an individual electric stimulation scheme fitting unit for fitting an individual electric stimulation scheme by using image data and a provided preliminary parameter set, a simulation control unit for verifying the effect of the electric stimulation scheme and controlling the electrode group to apply electric stimulation, an interactive interface of the simulation control unit and a display for real-time display of data, and an electrode group for outputting stimulation current. Through the modular and systematic cooperation of the system structure and the safety monitoring mechanism, the docking with the non-invasive medical electric stimulation device and the intelligent control of the non-invasive medical electric stimulation device can be provided, the diagnosis and treatment data of the operator is uniformly managed and individualized analyzed, and the whole electric stimulation life cycle process is traceable and sustainable optimized. The system provided by the present application can therefore provide an intelligent scheme control of time interference electric stimulation physiotherapy, and improve the clinical usability of this treatment method.

[0006] Specifically, the present application relates to the following aspects: A time-interference electric stimulation simulation and control system, comprising: a simulation control unit comprising a processor, configured to receive MR brain images and / or CT brain images to construct an individual brain tissue model, receive a preliminary parameter set of stimulation current, obtain a secondary parameter set of stimulation current by parameter inverse solving based on the individual brain tissue model and the preliminary parameter set, obtain a final parameter set of stimulation current by stimulation simulation based on the individual brain tissue model and the secondary parameter set, and control an electrode group to output the stimulation current under the final parameter set; a display configured to display the individual brain tissue model, the parameter inverse solving result, the stimulation simulation result, and provide an interactive interface of the simulation control unit, the interactive interface being configured to adjust the operation of the simulation control unit; and the electrode group comprising a plurality of electrode pairs, the electrode group being electrically connected to the simulation control unit, configured to receive the stimulation current under the final parameter set, and controlled by the simulation control unit to discharge at a target electrode position by using the plurality of electrode pairs; wherein the preliminary parameter set comprises an electric stimulation target point, an electrode pair configuration, and / or a current characteristic parameter.

[0007] According to some embodiments, the simulation control unit obtains the secondary parameter set of stimulation current by parameter inverse solving based on the individual brain tissue model and the preliminary parameter set comprises: the simulation control unit calculates, according to the electric stimulation target point, effective electrode positions, effective current amplitudes, and / or effective current frequencies required for implementing electric stimulation in the individual brain tissue model to form the secondary parameter set.

[0008] According to some embodiments, the calculation of the effective electrode positions required for implementing electric stimulation in the individual brain tissue model comprises: calculation of the electric field intensity of the electric field generated by the stimulation electrodes on both sides of the electric stimulation target point to determine the effective electrode positions at which the stimulation electrodes are located to maximize the electric field intensity and / or focusing degree at the electric stimulation target point.

[0009] According to some embodiments, the interactive interface comprises a first interface configured to receive input instructions to change the values of the effective electrode positions, the effective current amplitudes, and / or the effective current frequencies; and the simulation control unit calculates the effective electrode positions, the effective current amplitudes, and / or the effective current frequencies required for implementing electric stimulation in the individual brain tissue model comprises: the simulation control unit determines the effective electrode positions according to the combination of the stimulation electric fields generated by the electrodes on both sides of the electric stimulation target point and / or the electric field focusing degrees of the respective electrodes at the electric stimulation target point, and determines the effective current amplitudes according to the combination of the stimulation electric fields generated by the electrodes on both sides of the electric stimulation target point.

[0010] According to some embodiments, the stimulation simulation comprises: the simulation control unit performs finite element or multi-physical field simulation according to the individual brain tissue model and the secondary parameter set to generate field intensity distribution data, beat frequency distribution data, and / or beat frequency of the stimulation current under the secondary parameter set at the target point in the individual brain tissue model.

[0011] According to some embodiments, the interaction interface comprises a second interface configured to receive preset electrode positions, preset current amplitudes and / or preset current frequencies to form a preset parameter set; the simulation control unit generates, according to the individual brain tissue model and the preset parameter set, a field intensity distribution map of the stimulation current at the target point in the individual brain tissue model under the preset parameter set, a beat frequency distribution map and / or a beat frequency frequency.

[0012] According to some embodiments, the interaction interface further comprises a third interface configured to receive input instructions to change one or more parameters in the secondary parameter set.

[0013] According to some embodiments, the simulation control unit obtains the final parameter set of the stimulation current based on the individual brain tissue model and the secondary parameter set through stimulation simulation, comprising: the simulation control unit generates new field intensity distribution data, beat frequency distribution data and / or beat frequency frequency through the changed one or more parameters in the secondary parameter set until the field intensity distribution data, beat frequency distribution data and / or beat frequency frequency reaches the expectation, and determines the changed secondary parameter set as the final parameter set.

[0014] According to some embodiments, the simulation control unit receives MR brain images and / or CT brain images to construct the individual brain tissue model, comprising: the simulation control unit performs image preprocessing on the MR brain images and / or CT brain images, segments the skull, brain tissue and target point, and generates the individual brain tissue model by using a three-dimensional reconstruction method.

[0015] According to some embodiments, the simulation control unit controls the electrode group to output the stimulation current under the final parameter set, comprising: the simulation control unit sets the effective electrode positions of the plurality of electrode pairs respectively to respectively transport the stimulation current with the effective current amplitudes and / or effective current frequencies to the plurality of electrode pairs.

[0016] According to some embodiments, the simulation control unit further comprises a memory for storing the individual brain tissue model, the effective electrode positions, the effective current amplitudes, the effective current frequencies, the field intensity distribution data, the beat frequency distribution data and / or the beat frequency frequency.

[0017] Compared with the prior art, the time interference electric stimulation simulation and control system provided by the present application has the following beneficial effects: The system automatically constructs an individualized brain tissue model based on the input MRI and / or CT brain images of the stimulation object, accurately predicts the electric field distribution in the target point by using the model and a reverse solving method, and realizes individualized modeling and accurate time interference stimulation of deep brain regions. The system provides the whole process implementation from electric field simulation, stimulation simulation to stimulation implementation, integrates simulation and control operation into real electric stimulation tasks, and thus realizes the closed-loop control mechanism of electric stimulation parameter mapping, electric stimulation real-time monitoring and feedback adjustment; through the combination of reverse solving of electric field simulation and forward simulation verification of electric stimulation, the optimization time of each parameter can be greatly shortened, the trial and error cost of stimulation scheme can be reduced, and thus the scientificity and safety of stimulation configuration can be improved; In addition, the system also has high scalability and reusability, adopts modular design, can support electric field simulation algorithm updating and interactive function extension, and experimental data and parameter configuration can be stored and reused for a long time, so that the system can be used for neural regulation rule exploration in neuroscience research, and can also assist the treatment of clinical neurological diseases, and has broad application prospects. BRIEF DESCRIPTION OF DRAWINGS

[0018] Figure 1 FIG. 1 illustrates a structural block diagram of a time-interference electric stimulation simulation and control system according to an embodiment of the present application.

[0019] Figure 2 FIG. 2 illustrates a first schematic diagram of a time-interference electric stimulation simulation and control system according to an embodiment of the present application.

[0020] Figure 3 FIG. 3 illustrates a second schematic diagram of a time-interference electric stimulation simulation and control system according to an embodiment of the present application.

[0021] Figure 4 FIG. 4 illustrates a third schematic diagram of a time-interference electric stimulation simulation and control system according to an embodiment of the present application.

[0022] Figure 5 FIG. 5 illustrates a flowchart of a time-interference electric stimulation simulation and control method according to an embodiment of the present application. DETAILED DESCRIPTION

[0023] The present application will be further described below in conjunction with embodiments. It should be understood that the embodiments are only used to further illustrate and explain the present application, and are not used to limit the present application.

[0024] Unless otherwise defined, technical and scientific terms used in this specification have the same meaning as commonly understood by one of ordinary skill in the art. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present application, exemplary methods and materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and not intended to be limiting. The present application will be further described below in conjunction with specific embodiments, but not to limit the scope of the present application.

[0025] SUMMARY As mentioned earlier, existing brain neuromodulation systems still have shortcomings in terms of accuracy, scalability, and medical engineering translation. These shortcomings are mainly reflected in the following aspects: Existing systems mostly use standardized human brain structure models, making it difficult to reflect the differences in skull thickness, brain tissue conductivity, and morphological structure among individual subjects. Differences in the distribution of physical quantities such as electric and magnetic fields reduce the reliability of simulation results. Neuron grid simulation algorithms lack the ability to describe the dynamic processes of large-scale brain regions and cannot effectively simulate the impact of changes in stimulus parameters on neural activation and signal propagation, resulting in low accuracy in predicting stimulus responses. Simulation and experiment are independent systems with high coupling between algorithm modules, lacking a unified data management, parameter flow, and result reuse mechanism, making it difficult to achieve cross-task model verification and parameter optimization. Furthermore, the lack of parameter verification, output monitoring, and real-time feedback control channels makes it difficult to establish a mapping mechanism from obtaining simulation results to controlling actual stimulation components, hindering support for experimental or clinical applications.

[0026] To address the aforementioned issues, this application provides a simulation and control system for TI electrical stimulation. The system's simulation control unit utilizes brain imaging data to construct a high-precision, individualized brain tissue model and optimizes electrical stimulation parameters. It also incorporates a neuronal grid-level simulation algorithm to dynamically analyze neural activity. Simultaneously, from acquiring imaging data to establishing a specific brain tissue model, determining stimulation parameters, and obtaining simulation results, the system ensures the controllability and scalability of each component through a unified display, management, and modular interactive interface. The generated brain tissue model, parameter solution data, and simulation data can also be stored and reused. Furthermore, by integrating the simulation control unit and electrode assembly, the system provides a time-interference electrical stimulation scheme that forms a closed-loop system from modeling and simulation to implementation and feedback regulation, providing a precise and easily traceable task environment for neuromodulation research.

[0027] The construction of this system will help improve the parameter accuracy and electrical stimulation repeatability of TI brain neuromodulation technology, promote the customization and systematization of neuromodulation mechanism research, and drive the integration of neural engineering, cognitive science and clinical medicine.

[0028] After introducing the basic principles and objectives of this application, various non-limiting embodiments of this application will be described in detail below with reference to the accompanying drawings.

[0029] Exemplary System Figure 1 The figure shows a structural block diagram of a time-interference electrical stimulation simulation and control system according to an embodiment of this application.

[0030] like Figure 1 As shown, the time-interference electrical stimulation simulation and control system according to an embodiment of this application includes the following components.

[0031] The simulation control unit includes a processor, which is used to receive MR brain images and / or CT brain images to construct an individual brain tissue model, receive a preliminary parameter set of stimulation current, obtain a secondary parameter set of stimulation current by inverse parameter solving based on the individual brain tissue model and the preliminary parameter set, obtain a final parameter set of stimulation current by stimulation simulation based on the individual brain tissue model and the secondary parameter set, and control the electrode group to output the stimulation current under the final parameter set.

[0032] Specifically, the processor in the simulation control unit can be functionally divided into a parameter solving unit, a simulation unit, and a control unit, each executing relatively independent software functions. These three functional units can be understood as three manifestations of the processor: one executing corresponding computer program instructions when constructing the brain tissue model and solving parameters; another executing corresponding computer program instructions during stimulation simulation; and the third executing corresponding computer program instructions when controlling the electrode assembly. Therefore, the parameter solving unit, simulation unit, and control unit communicate with each other and can operate distributedly or synchronously, depending on the number of processor threads, the speed of executing computer program instructions, and the system's usage requirements. Furthermore, the parameter solving unit, simulation unit, and control unit can also be three relatively independent, communicable processors to implement their respective functions. A general-purpose CPU, such as a desktop CPU or server CPU, is preferred to provide stronger task processing and function implementation capabilities; however, an embedded CPU can be selected when cost control is required.

[0033] The parameter solving unit receives and preprocesses MR and / or CT brain images of the operator to obtain an individual brain tissue model. It also receives a preliminary set of electrical stimulation parameters and calculates a secondary set of electrical stimulation parameters using the preliminary parameter set and the individual brain tissue model to obtain inverse solution data. The parameter solving unit has an image data input interface that receives image files in formats such as DICOM and NIfTI. The image data input interface can be a fiber optic interface, a USB interface, or an Ethernet interface.

[0034] Before the parameter solving unit acquires image data, the brain imaging data input by each operator is first managed. In one example, the system includes an operator management subunit, which is part of the parameter solving unit or an independent processor. This subunit provides basic operator information such as account passwords to various operators in the system through an interactive interface on the display to perform authentication. The system also includes a memory that communicates with the display, the parameter solving unit, and the simulation unit via wired, near-field, and / or Internet of Things (IoT) communication. The memory can be a local computer-readable storage medium or a remote server or distributed ledger. The operator management subunit compares the basic operator information input through the interactive interface with the basic operator information recorded in the memory in the background. Only after verifying that there is no difference between the two is the operator allowed to enter through the interactive interface and control each unit to perform the corresponding functions.

[0035] The operator management subunit and memory also support multi-operator account access control. Different operators are allowed access to their designated units based on pre-set permissions in the memory. For example, operators can access the control unit, while researchers can access the parameter solving unit and simulation unit. In one example, based on different access permissions to the parameter solving unit, simulation unit, and control unit, the system operators can be categorized into different groups such as technical operators, researchers, medical personnel, and administrators. This effectively controls the scope of system operations and prevents misoperations from adversely affecting the system or the operators.

[0036] After any type of operator successfully logs in, the operator management subunit will control the display to show the interface of the parameter solving unit, simulation unit, and control unit. Users can trigger the interface via touch or gestures to quickly access the corresponding unit, improving system efficiency and user experience. During operator login and access, the memory automatically records the operator's operation log, including login time, units entered and exited, and operation results. This ensures that the entire system usage process is recorded, facilitating subsequent security audits and traceability of operator behavior.

[0037] The system's display is connected to the parameter solving unit, simulation unit, and control unit. Through the user interface provided on the display, the operator can easily switch between controlling any one of these units and control each unit to perform its corresponding function. It can be understood that the operator's control of the parameter solving unit, simulation unit, control unit, and / or operator management subunit through the display's interactive interface is essentially sending control commands to one or more independent, interconnected processors connected to the input device via an I / O interface, causing the latter to execute corresponding computer program instructions.

[0038] The parameter solving unit is one of the core components of the system. It automatically calculates the optimal electrode pair layout and electrical stimulation parameters based on target stimulation requirements, enabling personalized temporal interference stimulation scheme design. Specifically, the parameter solving unit receives input data to build a brain tissue model. The operator (e.g., medical personnel, researchers) uploads their MR and / or CT brain image files to the parameter solving unit, which then performs image preprocessing and 3D modeling. In one example, the parameter solving unit integrates a DICOM client, which can retrieve and obtain the operator's MR and / or CT image DICOM files from the hospital's or medical institution's PACS server. In other examples, the parameter solving unit has a mobile storage device interface or a network interface, allowing it to receive MR and / or CT image DICOM files from embedded mobile storage devices or files from IoT servers or distributed ledgers.

[0039] The preprocessing includes format conversion, head motion correction, standard spatial mapping, and image smoothing. Typically, this involves reading the DICOM file, converting it to a processable NIFTI format, and then performing head motion correction, standard spatial registration, and image smoothing. Other permitted image preprocessing techniques may also be used, and this application does not impose any restrictions on them. Then, the skull, brain tissue, and electrical stimulation target points in the preprocessed image are segmented. The segmentation results are used to reconstruct an individualized brain tissue model for the operator. This brain tissue model provides an accurate basis for subsequent electric field intensity distribution calculations and can be stored in a storage unit for later use.

[0040] In one example, the parameter solving unit rapidly extracts brain regions from preprocessed images using methods such as image thresholding, region growing, pre-trained neural networks, and standard atlas registration. The extraction process maintains high accuracy to avoid missing brain content. Through volume-based morphological segmentation or pre-trained neural networks, the skull is segmented from the brain regions, brain tissue is clustered, and target points for electrical stimulation, such as the prefrontal cortex and amygdala, are segmented. Then, a surface mesh generation algorithm stacks the binary masks of each segmentation result to obtain a 3D model surface mesh, which includes at least the skull, the brain tissue within the skull, and the meshes of specific target points. This forms the brain tissue model required for subsequent parameter solving and simulation verification.

[0041] The display's interactive interface can be, for example, a touchscreen or buttons. The operator uses the interface's interactive functions to set various electrical stimulation parameters required for the current TI electrical stimulation, including the stimulation target, stimulation frequency or frequency range, and electrode pair configuration. Electrode pair configuration includes the number of electrode pairs and the maximum safe current that each electrode pair can provide. The parameter solving unit, through the interactive interface provided by the display, allows the operator to intuitively configure multi-dimensional preliminary parameter combinations.

[0042] After obtaining the individualized brain tissue model and completing the parameter configuration, the parameter solving unit can initiate the reverse parameter solution. Specifically, the memory stores optimization algorithms, and the parameter solving unit calls the optimization algorithms from the memory to automatically calculate the effective electrode positions, electrical stimulation amplitudes, frequencies, and other parameters required to form the expected beat frequency electric field at the electrical stimulation target provided by the operator. These parameters are then integrated to obtain a secondary parameter set, and a reverse solution result file is generated.

[0043] In one example, the parameter solving unit uses a genetic algorithm stored in memory to calculate the electrode positions and corresponding stimulation current magnitudes. Specifically, the parameter solving unit calculates the electric field strength of the electric field generated by all electrode pairs at the target point, and then uses the genetic algorithm to determine the position of each electrode pair on the scalp surface that maximizes the electric field strength. For example, when the operator determines to use 72 electrodes and determines the electrical stimulation parameters, 216 continuous variables for the electrodes in a three-dimensional coordinate system are set, the objective function is set to maximize the interference electric field strength at the target point, and the interference electric field generated by the current provided by each electrode pair (i.e., the six continuous variables) at the target point is calculated based on a brain tissue model. The contribution vectors of all electric fields are summed to obtain the total interference electric field. When the electric field strength of the total interference electric field is maximized, the values ​​of all continuous variables are recorded to obtain the position of each electrode. Constraints such as electrode spacing and maximum safe current can be added, and the electrical stimulation amplitude can also be included as an additional continuous variable for each electrode in the calculation process to simultaneously determine the optimal current amplitude value.

[0044] In this way, the effective electrode positions and the current amplitude applied to each electrode pair are finally obtained. Finally, the parameter solving unit can determine the current frequency based on the characteristics of the target point, so that multiple currents generate a specific beat frequency due to time interference. Different target points are adapted to receiving stimulation at different beat frequencies; therefore, the correspondence between target points and beat frequencies can be stored in memory so that the parameter solving unit can call it to determine the current frequency according to the target point category. This realizes the entire parameter solving process, and the obtained parameters are individually adapted to the provider of the MR / CT image, ensuring high accuracy in personalized parameter customization.

[0045] In one example, the parameter solving unit presents the inverse solution result file on the display as a 3D graphic, including a brain tissue model, the coordinates of multiple electrode pairs surrounding the brain tissue model, and the electrical stimulation parameters applied by each electrode pair, such as amplitude and frequency, used to determine the beat frequency amplitude, frequency, and waveform. The parameter solving unit also provides a parameter modification interface on the display, which could be, for example, part of an operator interface. The operator can interact with the interface as needed to manually fine-tune the electrode pair positions and / or electrical stimulation parameters. The parameter solving unit will update the calculation results and display them based on the modified parameters.

[0046] Specifically, the parameter solving unit supports viewing the historical results of the aforementioned reverse calculations on the display, storing each set of parameters and corresponding calculation results in the memory. Operators can use the operator interface to call different brain tissue models and calculation results to the parameter solving unit for visual comparison and analysis, aiming to achieve parameter reuse or further optimize the electrical stimulation protocol. The memory also has an interface for communication with a computer device. The computer can transfer updated optimization algorithms to the remaining storage space of the memory through this interface, or overwrite the original optimization algorithms in the memory, to achieve iterative optimization.

[0047] The simulation unit is used to perform electrical stimulation simulation based on the secondary parameter set and individual brain tissue model, generating field strength distribution data and / or beat frequency data to optimize the secondary parameter set into the final parameter set or keep the secondary parameter set unchanged, ensuring the feasibility and safety of the design scheme; optionally, the simulation unit can be reconfigured via a display to perform the electrical stimulation parameters required for the stimulation policy, and the operator can control the simulation unit to perform the simulation in three ways.

[0048] Specifically, the first method involves the operator importing the reverse solution result file from the parameter solving unit into the simulation unit as simulation data via an interactive interface, or the parameter solving unit automatically importing the reverse solution result file into the simulation unit as simulation data. The simulation unit then parses the reverse solution result file and automatically fills in the brain tissue model, electrode pair configuration data, and electrical stimulation parameters. The second method involves the operator logging into the system through the management subunit and directly entering the simulation unit. In this case, the simulation unit provides a parameter modification interface on the display, through which the operator manually inputs various parameters required for simulation, such as uploading MR and / or CT brain images to generate a brain tissue model, directly uploading the brain tissue model, setting effective electrode positions, and / or electrical stimulation parameters for each electrode pair. The third method involves selecting an existing brain tissue model, effective electrode positions, and / or electrical stimulation parameters stored in the memory as simulation data. Understandably, in this case, some data can come from the memory, and other data can come from the operator's manual input.

[0049] Furthermore, the simulation unit performs finite element or multiphysics simulations using the simulation model, generating target point electric field intensity distribution data and beat frequency data as simulation results. The simulation unit controls the display to show the electrode pair coordinates in the brain tissue model, as well as the field intensity distribution and beat frequency distribution throughout the brain region, especially at the target point, and parameters such as the frequency and waveform of the beat frequency. The operator can freely rotate and cut the brain tissue model, and adjust the color and depth angle of the displayed electrode pairs, field intensity, etc., so as to observe the position of each electrode and the distribution effect of the electric field from different angles.

[0050] Specifically, the field strength distribution data generated by the simulation unit can be stored and reused in memory. If the brain tissue model, electrode pair configuration data, and electrical stimulation parameters input to a simulation are unchanged or significantly different from the previous input, the simulation can skip the step of generating field strength distribution data and use the previous field strength distribution data recorded in memory, thus speeding up the simulation. If the previous simulation or an earlier simulation did not generate field strength distribution data, it can be generated in the current simulation as needed. This requires additional time, but it can significantly improve the simulation effect and its ability to guide parameter adjustments.

[0051] In one example, the simulation unit generates target field strength distribution data and beat frequency interference data using actuator finite element analysis. Continuous partial differential equations are discretized onto each grid cell of the brain tissue model, forming a system of linear equations with multiple variables and parameters. The potential value at each node is then solved using iterative methods, such as the conjugate gradient method. The electric field strength is obtained by calculating the negative gradient of the potential. The electric field strength is displayed chromatographically on the coronal, sagittal, and / or horizontal planes where the target point is located; for example, the highest field strength region is represented in red, the lowest field strength region in blue, and intermediate regions are transitioned by a red-blue gradient. The simulation unit can also control the display to highlight areas in the brain tissue model that reach a specific field strength threshold or have a target beat frequency, visually showing the three-dimensional shape and extent of the effectively stimulated target location. For example, the region affected by a 2 Hz sinusoidal beat frequency is highlighted, and the proportion of this region relative to or beyond the stimulated target point is output and displayed to quantify the simulation results.

[0052] The simulation unit also provides historical results management and comparative analysis functions. It uploads all simulation task records, including each simulation request, input simulation data, electrode pair coordinates, field strength distribution data and beat frequency parameters in the generated 3D model, to the memory. Operators can access the memory through the monitor to view the historical simulation records of different brain tissue models under various parameter configurations, so as to compare and analyze different electrode pair configurations and electrical stimulation parameter combinations and quickly select the optimal stimulation scheme.

[0053] In particular, the parameter modification interface also provides functions for adjusting the coordinates of multiple electrode pairs at multiple points (usually dozens) on the entire scalp, adjusting electrical stimulation parameters such as current amplitude and frequency from 0 to maximum values, and selecting waveforms from the waveform library stored in memory. Therefore, the parameter modification interface can help operators manually configure parameters such as effective electrode position, effective current amplitude, effective current frequency and / or waveform, so as to promptly switch to manual configuration when the parameter solving unit or simulation unit runs into error.

[0054] The memory also has an interface for electrical connection to computer equipment. The computer can transfer updated simulation models to the remaining storage space of the memory through the interface, or overwrite the original simulation models in the remaining storage space, so as to realize the iteration of the simulation model. When the electrode pair configuration and electrical stimulation parameters are optimized by the simulation unit to achieve a beat frequency that reaches the preset field strength, frequency and waveform at the stimulation target point, or to achieve a beat frequency that reaches the preset field strength, frequency and waveform at the stimulation target point without optimization, these parameters are output to the control unit as the final parameter set.

[0055] The control unit outputs time-interference electrical stimulation currents to the operator via multiple electrode pairs from the electrode array, based on a final parameter set, and monitors the current supplied by the electrode pairs and the skin contact impedance. The control unit is electrically connected to all electrode pairs and their power supply components. It issues commands to the power supply components to cause specific electrode pairs to generate stimulation currents with specific parameters. The number of compatible stimulation electrodes is typically 2-64, but can be more. The display also includes a command input interface, through which the operator determines the start and end times of electrode pair discharges. The power supply components include a signal generator for generating specific waveform signals and a constant current source for generating current based on the waveform signals, continuously supplying current with specific waveform, amplitude, and frequency to the electrode pairs during operation.

[0056] The core function of the control unit is to map the simulation results from the simulation unit onto multiple electrode pairs in the real-world electrode array, achieving precise temporal interference electrical stimulation of each patient's target point. While ensuring accurate execution of the stimulation protocol, the control unit provides a function for repeated execution, recording data during each execution. Specifically, the operator can use the control unit in two ways: first, by manually inputting the required number and location of electrode pairs, as well as all parameters such as the amplitude, frequency, and waveform of the stimulation current applied to each electrode pair, directly through the command input interface; second, by commanding the control unit to automatically load the final parameter set calculated or optimized from the simulation unit through the command input interface.

[0057] The parameters configured by the control unit for the electrode set include: the number of electrode pairs, which can be, for example, 32, 64, or 72 or more, with each pair consisting of two electrodes. The position on the scalp where the electrodes are applied is determined according to the operator's configuration or final parameter set; the parameters of the current applied to each electrode pair are consistent with the operator's configuration or final parameter set, and the waveform of the current can be a sine wave, square wave, triangle wave, or pulse, etc.; the discharge duration and fade-in and fade-out times of the electrode pairs, which can be configured by the operator through the command input interface; and the skin contact impedance threshold of the electrode pairs, which can be configured by the operator through the command input interface. When the control unit detects that the skin contact impedance has reached the threshold, it controls the display to emit a visual signal, such as a warning icon or light signal, to alert the operator to potential dangers during the stimulation process.

[0058] The control unit also provides a parameter initialization function, which can reset parameters with one click when they are configured incorrectly or need to be restored to their initial values. The operator can save the parameters configured once as preset parameters and store the preset parameters in the memory. When the same stimulation is performed multiple times in a subsequent cycle, the control unit quickly loads the preset parameters from the memory and configures them to the corresponding electrode pairs, improving the operating efficiency of the system and facilitating long-term clinical treatment and experimental reproduction.

[0059] In this way, the simulation control unit, display, and electrode assembly are modularly and extensibly integrated. The system calls upon simulation results to configure electrical stimulation parameters, realizing a complete closed-loop process from modeling and solving TI electrical stimulation parameters to simulation verification and actual stimulation. Operators can make necessary adjustments to the number, position, current magnitude, and waveform of electrodes during parameter solving and / or simulation verification before stimulation, or during stimulation. Simultaneously, the system can save the data generated by each unit, achieving personalized and easily traceable stimulation control for different individuals.

[0060] The following will be through Figures 2-4 Operational examples of the time-interference electrical stimulation simulation and control system described in the above embodiments are provided.

[0061] Figure 2The illustration shows the interface view of the display provided by the system described in this application for determining the location of target points in the brain region to be stimulated. One function of the display is to provide operators, such as researchers or medical personnel, with an intuitive view of the target points in an individual brain tissue model, providing basic data support for subsequent inverse parameter solving and forward simulation. The display generates a three-dimensional brain tissue model based on the patient's MR or CT image data acquired by the system (with the patient's informed consent), and assists the operator in positioning the target points through multiple views, including axial, sagittal, coronal, and three-dimensional brain tissue models. The interface is divided into four main areas, displaying two-dimensional cross-sectional views in the axial, sagittal, and coronal planes, as well as a three-dimensional model view. Each view is labeled with the three-dimensional coordinate system RL, AP, and SI of the brain tissue and provides real-time coordinate information of the target point location to be stimulated. The three-dimensional model view in the lower right corner intuitively displays the spatial relationship of the brain tissue, allowing the operator to adjust the viewing angle through rotation, zoom, and other operations to locate important positions such as the target points.

[0062] The left side of the display features a function bar that, following modular and streamlined principles, presents the interaction interfaces with the parameter solving unit, simulation unit, and control unit independently. Operators can switch between units as needed, providing a complete workflow from image data import to personalized stimulation. The layout of the function bar makes the provided operations more intuitive, improving system efficiency.

[0063] Figure 3 The diagram illustrates the inverse solution results of the parameter solving unit on the display. The right side of the interface is divided into four main display areas: axial, sagittal, coronal, and a 3D view. Through multi-angle displays, the operator can comprehensively understand the electric field distribution at and around the target point, as well as the electrode layout. The axial, sagittal, and coronal views present the electric field distribution at the target point in horizontal, sagittal, and coronal sections, respectively, while the 3D view shows the position of the electrodes on the scalp and the resulting electric field distribution in a three-dimensional format. During the operation, the operator first uploads the patient's brain MR image file and configures relevant electrical stimulation parameters as needed, such as target location, electrode pair configuration, and electrical stimulation frequency.

[0064] After parameter configuration, a "Start Solving Interaction" button is located in the lower left corner of the interface. The parameter solving unit will automatically run the inverse solving algorithm to calculate the optimal electrode position that meets the target stimulation requirements. The function control panel on the left side of the interface provides convenient parameter adjustment functions. The operator can fine-tune the electrode position and stimulation parameters based on the simulation results to further optimize the electric field distribution effect. In addition, the calculation results of the parameter solving unit can be seamlessly connected to the simulation unit as input data for electric field verification. The simulation results after parameter optimization are directly mapped to the control unit for actual non-invasive electrical stimulation operations, thereby realizing a complete closed-loop control process from modeling to simulation.

[0065] Figure 4 The diagram illustrates the electrode placement settings of the simulation unit on the display screen. This is used to verify whether the electrode pair positions, current amplitudes, and current frequencies obtained through inverse engineering can effectively stimulate the target point, and to confirm whether a stable and accurate beat frequency has been formed at the target point. The left side of the interface provides interactive modules including inverse engineering data import, electrode pair configuration, field strength file generation options, and electrical stimulation parameter adjustment boxes. Operators can import brain tissue models from the parameter solving unit or external input interfaces, and the electrode pair positions and corresponding electrical stimulation parameters calculated by the parameter solving unit will be automatically configured, or the electrode pair positions and corresponding electrical stimulation parameters can be manually configured. Interactive buttons at the bottom of the display screen allow operators to save the current configuration and start the simulation task.

[0066] In addition, the central area of ​​the display screen displays axial, sagittal, and coronal views. Each view is labeled with the coordinate system of the brain tissue model and the coordinates of the target point. Operators can adjust the viewing angle through rotation, zoom, and other operations to further observe the spatial relationship between the electrode pairs and the brain tissue. The 3D model view on the right side of the display screen shows the brain tissue structure and electrode pair layout in a three-dimensional form, allowing operators to adjust the viewing angle interactively to locate the target point. The simulation unit follows the principles of modularity and process flow, and through the combination of multi-view display and interactive functions, operators can efficiently and intuitively complete data input and simulation result observation.

[0067] The display also features a control unit interface, which maps the electrical stimulation parameters obtained through simulation after reverse engineering to the actual electrode sets, enabling precise, non-invasive electrical stimulation of the target area. The main body of the interface is divided into three parallel configuration areas, each corresponding to a power supply component controlling one of the three independent electrode sets. Each area automatically configures optimized electrical stimulation parameters to the power supply component, or the operator can manually configure these parameters, including electrode position, stimulation waveform, stimulation period, stimulation duration, stimulation frequency, and the rise and fall durations of the stimulation initiation / termination phases. It also displays real-time parameters such as current frequency, amplitude, and contact impedance for each electrode pair in each electrode set. The power supply component is a constant current source. The remaining stimulation duration is displayed in real-time at the bottom of the interface, allowing the operator to monitor progress. This interface supports simultaneous configuration of multiple devices and channels by operating the control unit, providing efficient and precise parameter configuration and execution tools for complex neuromodulation tasks, effectively supporting neuroscience research and adjunctive treatment of nervous system diseases.

[0068] Exemplary Method This application also provides a method for determining, simulating, and controlling the application of electrical stimulation parameters for time-interference electrical stimulation.

[0069] Figure 5The illustration shows a flowchart of a time-interference electrical stimulation simulation and control method according to an embodiment of this application.

[0070] like Figure 5 As shown, the time-interference electrical stimulation simulation and control method according to the embodiments of this application includes the following steps.

[0071] Step S110: Data acquisition and modeling, acquiring MR brain images and / or CT brain images, and generating individualized three-dimensional brain tissue models through image preprocessing and three-dimensional reconstruction.

[0072] Step S120: Inverse solution, select the stimulation target point, configure the electrode pair and preliminary electrical stimulation parameters, and perform inverse solution to calculate the inverse solution result of forming the optimal interference electric field at the target point, including the electrode pair coordinates and electrical stimulation parameters.

[0073] Step S130: Simulation verification. Based on the inverse solution results, the electric field distribution is calculated, generating a three-dimensional field strength distribution map and a beat frequency interference visualization model to optimize the electrode pair coordinates and electrical stimulation parameters. In this step, the operator can fine-tune the parameters according to the simulation results; the verified parameter set can be saved as a preset scheme for subsequent rapid loading or batch experiments.

[0074] Step S140: TI Stimulation Control. Based on the optimization results, stimulation control commands are automatically generated and sent to the electrode group to configure the electrode pairs and the electrical stimulation parameters on each electrode. The power supply component of each electrode pair generates a corresponding stimulation current, which is then discharged by the electrode pair. Real-time acquisition of current waveforms, amplitudes, frequencies, and the contact impedance between the electrodes and the skin is used for electrical stimulation monitoring, providing continuous feedback. Simulation results and stimulation control commands can be uniformly archived and stored to support command reuse, comparison of historical simulation results, parameter backtracking, and result export, for use in assisting scientific research analysis or reproducing clinical diagnosis and treatment.

[0075] Here, those skilled in the art will understand that the specific operations of each step in the above-described time-interference electrical stimulation simulation and control method have been referenced above. Figures 1-5 The description of the time-interference electrical stimulation simulation and control system is detailed here. The time-interference electrical stimulation simulation and control method can perform efficient and accurate TI electrical stimulation on different individuals based on the time-interference electrical stimulation simulation and control system. Therefore, repeated descriptions of the various technical features of the method will be omitted.

[0076] The basic principles of this application have been described above with reference to specific embodiments. However, it should be noted that the advantages, benefits, and effects mentioned in this application are merely examples and not limitations, and should not be considered as essential features of each embodiment of this application. Furthermore, the specific details disclosed above are for illustrative and facilitative purposes only, and are not limitations. These details do not limit the application to the necessity of employing the aforementioned specific details for implementation.

[0077] The block diagrams of devices, apparatuses, devices, and systems involved in this application are merely illustrative examples and are not intended to require or imply that they must be connected, arranged, or configured in the manner shown in the block diagrams. As those skilled in the art will recognize, these devices, apparatuses, devices, and systems can be connected, arranged, and configured in any manner. Words such as “comprising,” “including,” “having,” etc., are open-ended terms meaning “including but not limited to,” and are used interchangeably with them. The terms “or” and “and” as used herein refer to the terms “and / or,” and are used interchangeably with them unless the context clearly indicates otherwise. The term “such as” as used herein refers to the phrase “such as but not limited to,” and is used interchangeably with it.

[0078] It should also be noted that in the apparatus, equipment, and methods of this application, the components or steps can be disassembled and / or recombined. These disassemblies and / or recombinations should be considered as equivalent solutions of this application.

[0079] The above description of the disclosed aspects is provided to enable any person skilled in the art to make or use this application. Various modifications to these aspects will be readily apparent to those skilled in the art, and the general principles defined herein can be applied to other aspects without departing from the scope of this application. Therefore, this application is not intended to be limited to the aspects shown herein, but rather to be accorded the widest scope consistent with the principles and novel features disclosed herein.

[0080] The above description has been given for purposes of illustration and description. Furthermore, this description is not intended to limit the embodiments of this application to the forms disclosed herein. Although numerous exemplary aspects and embodiments have been discussed above, those skilled in the art will recognize certain variations, modifications, alterations, additions, and sub-combinations thereof.

Claims

1. A time-interference electrical stimulation simulation and control system, characterized in that, include: The simulation control unit includes a processor, which is used to receive MR brain images and / or CT brain images to construct an individual brain tissue model, receive a preliminary parameter set of stimulation current, obtain a secondary parameter set of stimulation current based on the individual brain tissue model and the preliminary parameter set by inverse parameter solving, obtain a final parameter set of stimulation current based on the individual brain tissue model and the secondary parameter set by stimulation simulation, and control the electrode group to output the stimulation current under the final parameter set. A display is used to show the individual brain tissue model, the results of the reverse engineering of parameters, the results of the stimulus simulation, and to provide an interactive interface for the simulation control unit, the interactive interface being used to adjust the operation of the simulation control unit; An electrode assembly, comprising multiple electrode pairs, is electrically connected to the simulation control unit for receiving stimulation current under a final parameter set and for being controlled by the simulation control unit to discharge at a target electrode location using the multiple electrode pairs. The preliminary parameter set includes electrical stimulation target points, electrode pair configurations, and / or current characteristic parameters.

2. The time-interference electrical stimulation simulation and control system according to claim 1, wherein, The simulation control unit obtains the secondary parameter set of the stimulation current through inverse parameter solving based on the individual brain tissue model and the preliminary parameter set. This includes: The simulation control unit calculates the effective electrode positions, effective current amplitudes, and / or effective current frequencies required for implementing electrical stimulation in the individual brain tissue model based on the electrical stimulation target points, in order to form the secondary parameter set.

3. The time-interference electrical stimulation simulation and control system according to claim 2, wherein, Calculating the effective electrode locations required to perform electrical stimulation in the individual brain tissue model includes: Calculate the electric field strength generated by the stimulating electrode on both sides of the electrical stimulation target point to determine the effective electrode position of the stimulating electrode that maximizes the electric field strength and / or focus at the electrical stimulation target point.

4. The time-interference electrical stimulation simulation and control system according to claim 2, wherein, The interactive interface includes a first interface configured to receive input commands to change the values ​​of the effective electrode position, effective current amplitude, and / or effective current frequency. The simulation control unit calculates the effective electrode locations, effective current amplitudes, and / or effective current frequencies required to perform electrical stimulation in the individual brain tissue model, including: The simulation control unit determines the effective electrode position based on the combination of the stimulation electric fields generated by the electrodes on both sides of the electrical stimulation target and / or the electric field focusing degree of each electrode on the electrical stimulation target, and determines the effective current amplitude based on the combination of the stimulation electric fields generated by the electrodes on both sides of the electrical stimulation target.

5. The time-interference electrical stimulation simulation and control system according to claim 1, wherein, The stimulus simulation includes: The simulation control unit performs finite element or multiphysics simulation based on the individual brain tissue model and the secondary parameter set, generating field strength distribution data, beat frequency distribution data and / or beat frequency of the stimulation current at the target point in the individual brain tissue model under the secondary parameter set.

6. The time-interference electrical stimulation simulation and control system according to claim 1, wherein, The interactive interface includes a second interface, which is configured to receive a preset electrode position, a preset current amplitude and / or a preset current frequency to form a preset parameter set; The simulation control unit generates, based on the individual brain tissue model and the preset parameter set, a field strength distribution map, a beat frequency distribution map, and / or a beat frequency at the target point in the individual brain tissue model under the preset parameter set.

7. The time-interference electrical stimulation simulation and control system according to claim 5, wherein, The interactive interface also includes a third interface configured to receive input instructions to change one or more parameters in the secondary parameter set.

8. The time-interference electrical stimulation simulation and control system according to claim 7, wherein, The simulation control unit obtains the final parameter set of the stimulation current through stimulation simulation based on the individual brain tissue model and the secondary parameter set, including: In response to the failure of the field strength distribution data, beat frequency distribution data, and / or beat frequency to meet expectations, the simulation control unit generates new field strength distribution data, beat frequency distribution data, and / or beat frequency by changing one or more parameters in the secondary parameter set until the field strength distribution data, beat frequency distribution data, and / or beat frequency meet expectations. Then, the changed secondary parameter set is determined as the final parameter set.

9. The time-interference electrical stimulation simulation and control system according to claim 1, wherein, The simulation control unit receives MR brain images and / or CT brain images to construct an individual brain tissue model, including: The simulation control unit performs image preprocessing on the MR brain images and / or CT brain images, segments the skull, brain tissue and target points, and generates the individual brain tissue model using a three-dimensional reconstruction method.

10. The time-interference electrical stimulation simulation and control system according to claim 1, wherein, The simulation control unit controls the electrode assembly to output the stimulation current under the final parameter set, including: The simulation control unit sets the effective electrode positions of the plurality of electrode pairs to deliver stimulation currents with effective current amplitude and / or effective current frequency to the plurality of electrode pairs.

11. The time-interference electrical stimulation simulation and control system according to claim 1, wherein the simulation control unit further includes a memory, the memory being used to store the individual brain tissue model, effective electrode location, effective current amplitude, effective current frequency, field strength distribution data, beat frequency distribution data and / or beat frequency.

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