Electromagnetic synchronous stimulation control device, method, equipment, medium and program product

Abstract

The invention relates to an electromagnetic synchronous stimulation control device and method, equipment, a medium and a program product, and the device comprises a target spot information generation module which is used for generating target spot position information; the stimulation parameter configuration module is used for generating a combined stimulation scheme data packet based on the stimulation parameter template and the target position information; the synchronous control instruction generation module is used for analyzing the combined stimulation scheme data packet and generating a first time sequence control signal and a second time sequence control signal; and the stimulation execution and feedback module is used for driving the transcranial direct current stimulation unit and the repeated transcranial magnetic stimulation unit to synchronously apply physical stimulation to the target spot position through the first time sequence control signal and the second time sequence control signal, collecting an electroencephalogram signal of the target object in real time and generating a stimulation execution log. Electromagnetic synchronous stimulation is applied to the same target spot at the same time, and the physiological addition and synergistic effect of an electric field and a magnetic field are utilized, so that the effect on reducing the epileptic seizure frequency and electroencephalogram epilepsy-like discharge is remarkable.

Description

Technical Field

[0001] This disclosure relates to the field of medical device technology, and in particular to an electromagnetic synchronous stimulation control device, method, equipment, medium, and program product. Background Technology

[0002] This section is intended to provide background or context for embodiments of this disclosure. The description herein is not intended to imply that it is prior art simply because it is included in this section.

[0003] Epilepsy is a common chronic neurological disorder that severely impacts patients' quality of life. Although most patients can control their seizures with medication, a portion develop drug-resistant epilepsy. For drug-resistant epilepsy of focal origin, surgical treatment is effective, but it has limitations such as being invasive, high-risk, unsuitable for some patients due to the epileptogenic focus being located in a functional area, and high economic costs.

[0004] Therefore, developing a novel neuromodulation device that can achieve higher stimulation efficacy, better therapeutic effects, and is safe and non-invasive is a technical problem that urgently needs to be solved in this field. Summary of the Invention

[0005] In order to at least partially solve one of the technical problems in the related art, this disclosure provides an electromagnetic synchronous stimulation control device, method, apparatus, medium and program product.

[0006] To achieve the above objectives, a first aspect of the exemplary embodiments of this disclosure provides an electromagnetic synchronous stimulation control device, comprising: The target information generation module is configured to acquire multimodal data of neurophysiology and imaging of the target object, perform fusion analysis on the multimodal data through a preset localization algorithm, determine the spatial location of the epileptogenic focus origin region in the cerebral cortex, map the spatial location to the scalp coordinate system, and generate target location information. The stimulation parameter configuration module is configured to acquire a preset individualized stimulation parameter template, and based on the stimulation parameter template and the target location information, generate a combined stimulation scheme data package containing the placement position of the cathode stimulation electrode, the focusing position of the magnetic field stimulation coil, the transcranial direct current stimulation parameters, and the repetitive transcranial magnetic stimulation parameters. The synchronous control instruction generation module is configured to parse the combined stimulation scheme data packet, generate a first timing control signal for controlling the transcranial direct current stimulation unit and a second timing control signal for controlling the repetitive transcranial magnetic stimulation unit, and keep the first timing control signal and the second timing control signal synchronously overlapped on the time axis. The stimulation execution and feedback module is configured to send the first timing control signal to the transcranial direct current stimulation unit, send the second timing control signal to the repetitive transcranial magnetic stimulation unit, drive the transcranial direct current stimulation unit and the repetitive transcranial magnetic stimulation unit to synchronously apply physical stimulation to the target location, and simultaneously collect the electroencephalogram (EEG) signal of the target object in real time and generate a stimulation execution log.

[0007] In some exemplary embodiments, the target information generation module is specifically configured as follows: The brain region extent of the epileptic focus was initially determined based on video electroencephalography. Based on cranial structural magnetic resonance imaging data, the epileptogenic focus origin region was determined from the brain region. Based on magnetoencephalography source analysis and structural imaging fusion, the epileptogenic focus origin region is mapped to individualized scalp coordinates.

[0008] In some exemplary embodiments, the stimulation parameter configuration module is specifically configured as follows: Call the preset transcranial direct current stimulation parameter table and repetitive transcranial magnetic stimulation parameter table; A first drive control word is generated based on the target scalp coordinate data and the transcranial direct current stimulation parameter table. The first drive control word includes cathode electrode channel selection, target current intensity value, stimulation duration, and electrode polarity configuration. A second drive control word is generated based on the target scalp coordinate data and the repetitive transcranial magnetic stimulation parameter table. The second drive control word includes information on magnetic stimulation coil channel selection, pulse frequency, pulse number, and stimulation intensity percentage. The first drive control word and the second drive control word are encapsulated in the same time frame and a time synchronization stamp is attached. Output the first and second drive control words with time synchronization stamps to the corresponding stimulation drivers.

[0009] In some exemplary embodiments, the synchronization control command generation module is specifically configured as follows: The start time and end time of the first timing control signal and the second timing control signal are the same; or, The first timing control signal and the second timing control signal are controlled to have a time window that completely overlaps within the duration.

[0010] In some exemplary embodiments, the stimulus execution and feedback module is specifically configured as follows: It extracts epileptiform discharge features from EEG signals and automatically generates stimulation pause or parameter downsampling commands in response to discharge frequency exceeding a preset threshold.

[0011] In some exemplary embodiments, the multimodal data of neurophysiology and imaging includes at least one of the following: Interictal video EEG, cranial structural MRI, and magnetoencephalography (MEG) source localization data.

[0012] Based on the same inventive concept, a second aspect of the exemplary embodiments of this disclosure provides an electromagnetic synchronization stimulation control method, comprising: Multimodal data of neurophysiology and imaging of the target object are acquired, and the multimodal data are fused and analyzed by a preset localization algorithm to determine the spatial location of the epileptogenic focus origin region in the cerebral cortex. The spatial location is then mapped to the scalp coordinate system to generate target location information. Obtain a preset individualized stimulation parameter template, and based on the stimulation parameter template and the target location information, generate a combined stimulation scheme data package containing the placement position of the cathode stimulation electrode, the focusing position of the magnetic field stimulation coil, the transcranial direct current stimulation parameters, and the repetitive transcranial magnetic stimulation parameters. The combined stimulation scheme data packet is parsed to generate a first timing control signal for controlling the transcranial direct current stimulation unit and a second timing control signal for controlling the repetitive transcranial magnetic stimulation unit, and the first timing control signal and the second timing control signal are kept synchronously overlapped on the time axis. The first timing control signal is sent to the transcranial direct current stimulation unit, and the second timing control signal is sent to the repetitive transcranial magnetic stimulation unit. The transcranial direct current stimulation unit and the repetitive transcranial magnetic stimulation unit are driven to synchronously apply physical stimulation to the target location. At the same time, the electroencephalogram (EEG) signal of the target object is collected in real time, and a stimulation execution log is generated.

[0013] Based on the same inventive concept, a third aspect of the exemplary embodiments of this disclosure provides an electronic device, including a memory, a processor, and a computer program stored in the memory, wherein the processor executes the computer program to implement the steps of the method as described in the first aspect.

[0014] Based on the same inventive concept, a fourth aspect of the exemplary embodiments of this disclosure provides a computer-readable storage medium having a computer program / instructions stored thereon, which, when executed by a processor, implement the steps of the method as described in the first aspect.

[0015] Based on the same inventive concept, a fifth aspect of the exemplary embodiments of this disclosure provides a computer program product, including a computer program / instructions that, when executed by a processor, implement the steps of the method as described in the first aspect.

[0016] The technical solution provided in this disclosure has the following advantages compared with the prior art: By applying synchronous electromagnetic stimulation at the same target point and time, and utilizing the physiological additive and synergistic effects of electric and magnetic fields, this approach is significantly more effective than either transcranial direct current stimulation alone or repetitive transcranial magnetic stimulation alone in reducing the frequency of epileptic seizures and epileptiform discharges on brain. Furthermore, this method is non-invasive, avoiding surgical risks and complications. Attached Figure Description

[0017] The accompanying drawings, which are incorporated in and form a part of this specification, illustrate embodiments consistent with this disclosure and, together with the description, serve to explain the principles of this disclosure.

[0018] To more clearly illustrate the technical solutions in the embodiments of this disclosure or the prior art, the accompanying drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, for those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0019] Figure 1 A schematic diagram of an electromagnetic synchronous stimulation control device provided for an exemplary embodiment of the present disclosure; Figure 2 A schematic flowchart of a comparative verification provided for an exemplary embodiment of this disclosure; Figure 3 A schematic diagram of verification phasing provided for an exemplary embodiment of this disclosure; Figure 4 A schematic diagram illustrating the trend of the number of seizures provided in an exemplary embodiment of this disclosure; Figure 5 A schematic diagram of abnormal electrical discharges in brainwaves provided as an exemplary embodiment of this disclosure; Figure 6 A schematic flowchart of an electromagnetic synchronous stimulation control method provided for an exemplary embodiment of the present disclosure; Figure 7 A schematic diagram of the structure of an electronic device provided as an exemplary embodiment of the present disclosure. Detailed Implementation

[0020] It is understood that the data involved in this technical solution (including but not limited to the data itself, the acquisition or use of the data) shall comply with the requirements of relevant laws, regulations and related provisions.

[0021] Embodiments of this disclosure will now be described in more detail with reference to the accompanying drawings. While some embodiments of this disclosure are shown in the drawings, it should be understood that this disclosure can be implemented in various forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided to provide a more thorough and complete understanding of this disclosure. It should be understood that the accompanying drawings and embodiments of this disclosure are for illustrative purposes only and are not intended to limit the scope of protection of this disclosure.

[0022] It should be understood that the steps described in the method embodiments of this disclosure may be performed in different orders and / or in parallel. Furthermore, the method embodiments may include additional steps and / or omit the steps shown. The scope of this disclosure is not limited in this respect.

[0023] The term "comprising" and its variations as used herein are open-ended inclusions, meaning "including but not limited to". The term "based on" means "at least partially based on". The term "one embodiment" means "at least one embodiment"; the term "another embodiment" means "at least one additional embodiment"; the term "some embodiments" means "at least some embodiments". Definitions of other terms will be given in the description below.

[0024] It should be noted that the concepts of "first" and "second" mentioned in this disclosure are used only to distinguish different devices, modules or units, and are not used to limit the order of functions performed by these devices, modules or units or their interdependencies.

[0025] It should be noted that the terms "a" and "a plurality of" used in this disclosure are illustrative rather than restrictive, and those skilled in the art should understand that, unless otherwise expressly indicated in the context, they should be understood as "one or more".

[0026] The names of messages or information exchanged between multiple devices in the embodiments of this disclosure are for illustrative purposes only and are not intended to limit the scope of such messages or information.

[0027] To better understand the above-mentioned objectives, features, and advantages of this disclosure, the solutions disclosed herein will be further described below. It should be noted that, unless otherwise specified, the embodiments and features described herein can be combined with each other.

[0028] Numerous specific details are set forth in the following description in order to provide a full understanding of this disclosure, but this disclosure may also be implemented in other ways different from those described herein; obviously, the embodiments in the specification are only some, and not all, of the embodiments of this disclosure.

[0029] Epilepsy is a common chronic neurological disorder that severely impacts patients' quality of life. Although most patients can control their seizures with medication, a portion develop drug-resistant epilepsy. For drug-resistant epilepsy of focal origin, surgical treatment is effective, but it has limitations such as being invasive, high-risk, unsuitable for some patients due to the epileptogenic focus being located in a functional area, and high economic costs.

[0030] Therefore, developing a novel neuromodulation device that can achieve higher stimulation efficacy, better therapeutic effects, and is safe and non-invasive is a technical problem that urgently needs to be solved in this field.

[0031] To address the aforementioned issues, this disclosure provides an electromagnetic synchronous stimulation control scheme, specifically comprising: a target information generation module, configured to acquire multimodal data of the target object's neurophysiology and imaging, perform fusion analysis on the multimodal data using a preset localization algorithm to determine the spatial location of the epileptogenic focus origin region in the cerebral cortex, and map the spatial location to a scalp coordinate system to generate target location information; a stimulation parameter configuration module, configured to acquire a preset individualized stimulation parameter template, and based on the stimulation parameter template and the target location information, generate a combined stimulation scheme data package containing the placement position of the cathode stimulation electrode, the focusing position of the magnetic field stimulation coil, transcranial direct current stimulation parameters, and repetitive transcranial magnetic stimulation parameters; synchronous control; The instruction generation module is configured to parse the combined stimulation scheme data packet, generate a first timing control signal for controlling the transcranial direct current stimulation unit and a second timing control signal for controlling the repetitive transcranial magnetic stimulation unit, and ensure that the first timing control signal and the second timing control signal are synchronously overlapped on the time axis; the stimulation execution and feedback module is configured to send the first timing control signal to the transcranial direct current stimulation unit and the second timing control signal to the repetitive transcranial magnetic stimulation unit, drive the transcranial direct current stimulation unit and the repetitive transcranial magnetic stimulation unit to synchronously apply physical stimulation to the target location, and simultaneously collect the EEG signal of the target object in real time and generate a stimulation execution log.

[0032] This approach, by applying synchronous electromagnetic stimulation at the same target point and time, leverages the physiological additive and synergistic effects of electric and magnetic fields to significantly reduce the frequency of epileptic seizures and epileptiform discharges on brain electrical activity compared to either transcranial direct current stimulation alone or repetitive transcranial magnetic stimulation alone. Furthermore, this method is non-invasive, avoiding surgical risks and complications.

[0033] After introducing the basic principles of this disclosure, various non-limiting embodiments of this disclosure will be described in detail below.

[0034] To address the aforementioned problems, this disclosure provides an electromagnetic synchronous stimulation control method, which will be described below with reference to specific embodiments.

[0035] Figure 1 This is a schematic diagram of an electromagnetic synchronous stimulation control device provided in an embodiment of this disclosure. The device can be implemented by software and / or hardware and is generally integrated into an electronic device. Figure 1 As shown, the device includes: a target information generation module 110, a stimulus parameter configuration module 120, a synchronization control command generation module 130, and a stimulus execution and feedback module 140, wherein: The target information generation module 110 is configured to acquire multimodal data of neurophysiology and imaging of the target object, perform fusion analysis on the multimodal data through a preset localization algorithm, determine the spatial location of the epileptogenic focus origin region in the cerebral cortex, map the spatial location to the scalp coordinate system, and generate target location information.

[0036] In some exemplary embodiments, the multimodal data of neurophysiology and imaging includes at least one of the following: Interictal video EEG, cranial structural MRI, and magnetoencephalography (MEG) source localization data.

[0037] In some exemplary embodiments, the target information generation module 110 is specifically configured as follows: The brain region extent of the epileptic focus was initially determined based on video electroencephalography. Based on cranial structural magnetic resonance imaging data, the epileptogenic focus origin region was determined from the brain region. Based on magnetoencephalography source analysis and structural imaging fusion, the epileptogenic focus origin region is mapped to individualized scalp coordinates.

[0038] The stimulation parameter configuration module 120 is configured to acquire a preset individualized stimulation parameter template, and based on the stimulation parameter template and the target location information, generate a combined stimulation scheme data package containing the placement position of the cathode stimulation electrode, the focusing position of the magnetic field stimulation coil, the transcranial direct current stimulation parameters, and the repetitive transcranial magnetic stimulation parameters.

[0039] In some exemplary embodiments, the stimulation parameter configuration module 120 is specifically configured as follows: Call the preset transcranial direct current stimulation parameter table and repetitive transcranial magnetic stimulation parameter table; A first drive control word is generated based on the target scalp coordinate data and the transcranial direct current stimulation parameter table. The first drive control word includes cathode electrode channel selection, target current intensity value, stimulation duration, and electrode polarity configuration. A second drive control word is generated based on the target scalp coordinate data and the repetitive transcranial magnetic stimulation parameter table. The second drive control word includes information on magnetic stimulation coil channel selection, pulse frequency, pulse number, and stimulation intensity percentage. The first drive control word and the second drive control word are encapsulated in the same time frame and a time synchronization stamp is attached. Output the first and second drive control words with time synchronization stamps to the corresponding stimulation drivers.

[0040] The synchronization control instruction generation module 130 is configured to parse the combined stimulation scheme data packet, generate a first timing control signal for controlling the transcranial direct current stimulation unit and a second timing control signal for controlling the repetitive transcranial magnetic stimulation unit, and keep the first timing control signal and the second timing control signal synchronously overlapped on the time axis.

[0041] In some exemplary embodiments, the synchronization control command generation module 130 is specifically configured as follows: The start time and end time of the first timing control signal and the second timing control signal are the same; or, The first timing control signal and the second timing control signal are controlled to have a time window that completely overlaps within the duration.

[0042] The stimulation execution and feedback module 140 is configured to send the first timing control signal to the transcranial direct current stimulation unit, send the second timing control signal to the repetitive transcranial magnetic stimulation unit, drive the transcranial direct current stimulation unit and the repetitive transcranial magnetic stimulation unit to synchronously apply physical stimulation to the target location, and simultaneously collect the EEG signal of the target object in real time and generate a stimulation execution log.

[0043] In some exemplary embodiments, the stimulus execution and feedback module 140 is specifically configured as follows: It extracts epileptiform discharge features from EEG signals and automatically generates stimulation pause or parameter downsampling commands in response to discharge frequency exceeding a preset threshold.

[0044] For ease of description, the above apparatus is described in terms of its functions, divided into various modules. Of course, in implementing this disclosure, the functions of each module can be implemented in one or more software and / or hardware.

[0045] To illustrate the validity of this disclosure, see reference to Figure 2 The following comparative verification was conducted: The inclusion criteria were as follows: for example, age 8 years ≤ age ≤ 60 years. Patients were diagnosed with focal epilepsy, with seizure types including focal epilepsy with impaired consciousness and focal epilepsy with clear consciousness, with or without progression to bilateral tonic-clonic seizures, including automatisms, hypermotor seizures, autonomic seizures, behavioral termination, cognitive seizures, emotional seizures, sensory seizures, and focal atonic seizures, clonic seizures, epileptiform seizures, myoclonic seizures, and tonic seizures. Patients had a history of epilepsy ≥ 2 years and had been on regular medication for ≥ 1 year. In the 3 months prior to enrollment, the seizure frequency was ≥ 1 time per week, with or without secondary seizures. The antiepileptic drug regimen remained unchanged for the first 4 weeks before baseline and was not changed or supplemented with traditional Chinese medicine treatment throughout the study period (31 weeks) unless there was a significant clinical need.

[0046] Exclusion criteria included: inability to clearly locate the epileptic focus or multiple epileptic foci; past or present psychogenic seizures; at least one episode of status epilepticus within the 6 months prior to screening; dementia, frequent or severe headaches, developmental delay, progressive brain disease (history of coma, intracranial infection, neurodegenerative disease) or systemic disease; severe physical diseases of the heart, lungs, liver, kidneys, etc., or severe neuropsychiatric disorders (severe depression, suicidal tendencies); history of alcohol addiction or drug abuse; planning pregnancy, pregnant women, and breastfeeding women; patients with pacemakers and defibrillators, intracardiac vagus nerve stimulators, cochlear implants, medical pumps, or other metal implants; history of head trauma or craniocerebral surgery; scalp abnormalities such as eczema or skin lesions; use of drugs affecting the central nervous system or psychotropic drugs other than AEDs; participation in other clinical trials, including drug trials or other neuromodulation therapy trials, during or within the 3 months prior to enrollment. Due to the rapid and recurrent seizures (dense clusters or paroxysmal attacks) in the subjects, reliable recording of seizures is difficult. Patients or their families who cannot properly record the subject's diary cards are not eligible (relatives who can closely accompany the subject and record detailed information about each seizure are also eligible).

[0047] The withdrawal criteria are as follows: The patient fails to follow the verification physician's instructions. The patient experiences status epilepticus during treatment and follow-up. The frequency of seizures increases significantly between the treatment and follow-up periods and baseline, and the clinician confirms, after consultation with the investigation physician, that the patient is unsuitable to continue the study. Other serious adverse events, complications, or special physiological changes occur, making continued study inappropriate; the investigation physician must be contacted. Changes to the medication regimen during treatment and follow-up require communication with the investigation physician. The food and drug administration decides to terminate the study for any reason.

[0048] The sample size was calculated using the GEE Tests for the TAD of Multiple Groups in a Repeated Measures Design (Continuous Outcome) module in PASS2020 software. Power was set to 0.9, α to 0.05, and three groups were established (electrotherapy group, magnetic therapy group, and combined electromagnetic therapy group). Each group had the same sample size. Measurement times were baseline, 1 week, 2 weeks, 3 weeks, 7 weeks, 11 weeks, 15 weeks, 19 weeks, 23 weeks, and 27 weeks, corresponding to the List of Measurement Time Proportions (0.0 0.1 0.2 0.3 0.4 0.6 0.7 0.9 1.0). Based on preliminary experimental results, the estimated total means for each group were 2.38, 2.88, and 1.9, with an estimated standard deviation of 2.5. The correlation coefficient between patients at different measurement time points within each group was set to AR1. (Traditional) means that the greater the time interval, the lower the correlation. The initial correlation coefficient was set to 0.2, the dropout rate was set to 20%, and the total sample size was calculated to be 105 people, with 35 people in each group.

[0049] The grouping method was as follows: patients who met the inclusion criteria were randomly divided into 3 groups after signing the informed consent form.

[0050] Random grouping method: As an example, an online random number table is used to randomly group patients. 105 numbers are randomly generated. Patients numbered 1-35 are assigned to group 1, 36-70 to group 2, and 71-105 to group 3 in advance. When patients are admitted to the group, they are admitted to the corresponding treatment group according to the order of admission and the corresponding random number for verification.

[0051] The study was divided into three phases: the study period was 31 weeks, including the baseline period, the treatment period, and the follow-up period.

[0052] refer to Figure 3 The baseline period is 4 weeks before stimulation (-4 W-0), during which the frequency of seizures (times / week) and epileptiform discharges in patients are evaluated. The stimulation treatment period lasts for 3 weeks (0-3 W), during which patients receive stimulation treatment. The follow-up period is 24 weeks after treatment (4 W-27 W), during which changes in the frequency of seizures (times / week) and epileptiform discharges in patients after treatment are observed, thereby evaluating the therapeutic effect, optimal regimen, safety and tolerability of the technology.

[0053] The stimulation parameters are as follows: Electrical stimulation: Both electrodes are placed on the scalp surface of the skull. The treatment electrode is placed on the scalp surface corresponding to the epileptic focus origin area (International Lead 10-20 system) and is the negative electrode; the reference electrode is placed in the area with the least impact on the epileptic focus and is the positive electrode. The electrode size is 7cm. 2 (Electrode surface covered with a conductive sponge soaked in physiological saline), current intensity 1.5 mA, current density 0.21 mA / cm² 2 The treatment consists of direct current stimulation for 20 minutes, constituting one sequence. This sequence is repeated every 20 minutes. A dummy treatment coil, identical in shape, texture, and sound to the real treatment coil but without magnetic stimulation, is also placed on the scalp surface corresponding to the identified epileptic focus origin area. One sequence consists of 1200 stimuli at 1 Hz, placed on the treatment area for 20 minutes, followed by a second identical sequence every 20 minutes. This constitutes the treatment sequence for Group 1 electrical stimulation.

[0054] Magnetic stimulation: The treatment electrode is placed on the scalp surface corresponding to the area identified as the epileptic focus origin, and is the negative electrode; the reference electrode is placed in the area with the least impact on the epileptic focus, and is the positive electrode. Electrode size: 7cm. 2 (Electrode surface covered with a conductive sponge soaked in physiological saline), current intensity 1.5 mA, current density 0.21 mA / cm² 2 The electrical stimulation began with a 25-second gradual increase in current followed by a 25-second slow decrease, with no stimulation input for the remaining time. The treatment coil was placed on the scalp surface corresponding to the epileptic focus origin area (International Lead 10-20 system). The treatment coil was a figure-eight coil, 87mm in diameter, with an output pulse of 90% rMT, 1Hz. 1200 stimulations constituted one sequence, and the second identical treatment sequence was repeated after a 20-minute interval. This was the treatment sequence for Group 2 magnetic stimulation group.

[0055] Electromagnetic stimulation: Electrodes and coils are simultaneously placed on the scalp surface of the skull. The treatment electrode (negative pole) and coil are placed on the scalp surface corresponding to the area identified as the epileptic focus origin (international lead 10-20 system). The reference electrode is placed in the area with the least impact on the epileptic focus, and is the positive pole. Electrode size: 7cm. 2 The current intensity is 1.5 mA, and the current density is 0.21 mA / cm². 2 The stimulation is direct current, lasting for 20 minutes, which constitutes one sequence. The same treatment sequence is repeated every 20 minutes. The treatment coil is a figure-eight coil with a diameter of 87 mm and an output induction intensity of 90% rMT at 1 Hz. 1200 stimulations constitute one sequence. The same treatment sequence is repeated every 20 minutes, which is the treatment sequence of the electromagnetic stimulation group 3.

[0056] Among them, the determination of the epileptic focus origin area is based on the patient's clinical symptom, interictal and ictal video EEG monitoring results, head MRI scan results and magnetoencephalography source localization results to comprehensively and accurately locate the focus (determined according to the preoperative assessment method as frontal lobe, medial temporal lobe, temporal lobe neocortex, central-parietal region and occipital lobe epilepsy).

[0057] The blinding process involved the following procedures: neither the subjects nor the follow-up personnel were aware of the patients' group assignments. Patient randomization numbers were assigned and maintained by independent personnel who did not have contact with the patients. The person administering stimulation therapy was aware of the patient's randomization but did not communicate this information to the follow-up personnel. The personnel conducting patient follow-up were unaware of the patient's randomization, as were those recording epileptiform discharges on the EEG. The patients themselves were also unaware of their randomization.

[0058] Blinding time: After the patient completes treatment and is followed up, and after the electroencephalogram is collected, the person who performed the stimulation therapy will inform the follow-up person to break the blindness.

[0059] The main observation indicator was the frequency of epileptic seizures, which was the number of focal seizures with or without progression to bilateral tonic-clonic seizures per week during the baseline period before treatment and the follow-up period after treatment. Patients and their families were required to keep a seizure diary and report the total number of seizures per week. The average frequency of epileptic seizures before and after treatment was calculated by averaging the frequency on the last day of the baseline period, the first day of the follow-up period, and the last day of the follow-up period.

[0060] Secondary observation indicators: EEG recording of epileptiform discharges: Scalp EEG was recorded 24 hours before and 24 hours after treatment using a 21-lead video EEG monitor with a frequency range of 0.5-70Hz. Patients were asked to sit comfortably in a well-lit room, awake, with their eyes closed and relaxed. Scalp EEG was recorded for 1 hour (referring to the international 10-20 lead system). The number of epileptiform abnormal waves, including sharp waves, spikes, and sharp (spiky) slow waves, was counted.

[0061] The average time to the first seizure after stimulation therapy was determined by diaries of epilepsy patients and their families, thereby assessing the duration, short-term effects, long-term effects, and intensity of the aftereffects of the technique.

[0062] The proportion of patients whose epileptic seizures disappeared was determined by analyzing the diaries of epilepsy patients and their families.

[0063] The data processing method was as follows: the data was processed using SPSS 22.0 software.

[0064] Quantitative data, including baseline characteristics such as gender, age, and disease duration, were analyzed using ANOVA among the three groups (electric stimulation, magnetic stimulation, and electromagnetic stimulation). Qualitative data were analyzed using the chi-square test. Repeated measures ANOVA was used to compare changes in the frequency of seizures and epileptiform discharges on EEG before and after treatment. Post-hoc comparisons were performed using Fisher's LSD. All measurement data in this study were expressed as mean (standard deviation), and P < 0.05 was considered statistically significant.

[0065] Among them, safety measures and adverse event reporting and handling: Active safety checks are conducted by designated personnel on days 8 and 15 of the treatment process. For the remaining days, the operator will conduct inquiries and contact the clinician if necessary. Patient vital signs are monitored during and after treatment, and adverse reactions are recorded in the study medical record. Patients are observed in the examination room for half an hour after treatment before leaving, with particular attention paid to skin reactions. Any epileptic seizures during treatment are recorded in the study medical record. If a focal seizure occurs during treatment, treatment is suspended until the seizure ends, at which point the remaining treatment time for the day is made up. If a generalized tonic-clonic seizure occurs during treatment, treatment for that day is immediately terminated, and no additional treatment is given.

[0066] The preliminary experimental results are as follows: refer to Figure 4 The study showed the trend of the average number of seizures per week in epilepsy patients over 27 weeks before and after different stimulation methods. Among them, after treating the epileptogenic zone of 9 enrolled patients with electrical stimulation tDCS, magnetic stimulation rTMS, and electromagnetic stimulation tDCS+rTMS, the number of epileptic seizures was reduced to varying degrees.

[0067] refer to Figure 5 The study showed the changes in the amount of abnormal EEG discharges between different stimulation methods in epilepsy patients within 24 hours. Among them, most patients showed a reduction in epileptiform discharges on their EEG after treatment compared to before treatment, and there were no obvious adverse reactions during the data collection process.

[0068] To achieve the above embodiments, this disclosure also proposes an electromagnetic synchronous stimulation control method.

[0069] Figure 2 This is a flowchart illustrating an electromagnetic synchronous stimulation control method provided in an embodiment of this disclosure. The method can be executed by an electromagnetic synchronous stimulation control device, which can be implemented using software and / or hardware, and is generally integrated into an electronic device. Figure 2 As shown, the method includes: Step 210: Obtain multimodal data of neurophysiology and imaging of the target object, perform fusion analysis on the multimodal data through a preset localization algorithm, determine the spatial location of the epileptogenic focus origin region in the cerebral cortex, map the spatial location to the scalp coordinate system, and generate target location information.

[0070] Step 220: Obtain a preset individualized stimulation parameter template. Based on the stimulation parameter template and the target location information, generate a combined stimulation scheme data package containing the placement position of the cathode stimulation electrode, the focusing position of the magnetic field stimulation coil, the transcranial direct current stimulation parameters, and the repetitive transcranial magnetic stimulation parameters.

[0071] Step 230: Parse the combined stimulation scheme data packet, generate a first timing control signal for controlling the transcranial direct current stimulation unit and a second timing control signal for controlling the repetitive transcranial magnetic stimulation unit, and keep the first timing control signal and the second timing control signal synchronously overlapped on the time axis.

[0072] Step 240: Send the first timing control signal to the transcranial direct current stimulation unit and the second timing control signal to the repetitive transcranial magnetic stimulation unit to drive the transcranial direct current stimulation unit and the repetitive transcranial magnetic stimulation unit to synchronously apply physical stimulation to the target location, while simultaneously collecting the EEG signal of the target object in real time and generating a stimulation execution log.

[0073] In some exemplary embodiments, step 210 specifically includes: The brain region extent of the epileptic focus was initially determined based on video electroencephalography. Based on cranial structural magnetic resonance imaging data, the epileptogenic focus origin region was determined from the brain region. Based on magnetoencephalography source analysis and structural imaging fusion, the epileptogenic focus origin region is mapped to individualized scalp coordinates.

[0074] In some exemplary embodiments, step 220 specifically includes: Call the preset transcranial direct current stimulation parameter table and repetitive transcranial magnetic stimulation parameter table; A first drive control word is generated based on the target scalp coordinate data and the transcranial direct current stimulation parameter table. The first drive control word includes cathode electrode channel selection, target current intensity value, stimulation duration, and electrode polarity configuration. A second drive control word is generated based on the target scalp coordinate data and the repetitive transcranial magnetic stimulation parameter table. The second drive control word includes information on magnetic stimulation coil channel selection, pulse frequency, pulse number, and stimulation intensity percentage. The first drive control word and the second drive control word are encapsulated in the same time frame and a time synchronization stamp is attached. Output the first and second drive control words with time synchronization stamps to the corresponding stimulation drivers.

[0075] In some exemplary embodiments, step 230 specifically includes: The start time and end time of the first timing control signal and the second timing control signal are the same; or, The first timing control signal and the second timing control signal are controlled to have a time window that completely overlaps within the duration.

[0076] In some exemplary embodiments, step 240 specifically includes: It extracts epileptiform discharge features from EEG signals and automatically generates stimulation pause or parameter downsampling commands in response to discharge frequency exceeding a preset threshold.

[0077] In some exemplary embodiments, the multimodal data of neurophysiology and imaging includes at least one of the following: Interictal video EEG, cranial structural MRI, and magnetoencephalography (MEG) source localization data.

[0078] It should be noted that the method of this disclosure embodiment can be executed by a single device, such as a computer or server. The method of this embodiment can also be applied to a distributed scenario, where multiple devices cooperate to complete the task. In such a distributed scenario, one of these devices may execute only one or more steps of the method of this disclosure embodiment, and the multiple devices will interact with each other to complete the method described.

[0079] It should be noted that the above description describes some embodiments of this disclosure. Other embodiments are within the scope of the appended claims. In some cases, the actions or steps recorded in the claims can be performed in a different order than that shown in the above embodiments and still achieve the desired result. Furthermore, the processes depicted in the drawings do not necessarily require a specific or sequential order to achieve the desired result. In some embodiments, multitasking and parallel processing are also possible or may be advantageous.

[0080] The electromagnetic synchronous stimulation control method provided in this disclosure can be executed by the electromagnetic synchronous stimulation control device provided in any embodiment of this disclosure, and has the corresponding functional modules and beneficial effects of the execution device.

[0081] To implement the above embodiments, this disclosure also proposes a computer program product, including a computer program / instructions, which, when executed by a processor, implements the electromagnetic synchronous stimulation control method in the above embodiments.

[0082] Figure 7 This is a schematic diagram of the structure of an electronic device provided in an embodiment of this disclosure.

[0083] The following is a detailed reference. Figure 7 The diagram illustrates a structural schematic suitable for implementing the electronic device 300 in the embodiments of this disclosure. The electronic device 300 in the embodiments of this disclosure may include, but is not limited to, mobile terminals such as mobile phones, laptops, digital broadcast receivers, PDAs (personal digital assistants), PADs (tablet computers), PMPs (portable multimedia players), in-vehicle terminals (e.g., in-vehicle navigation terminals), and fixed terminals such as digital TVs and desktop computers. Figure 7 The electronic device shown is merely an example and should not be construed as limiting the functionality and scope of the embodiments disclosed herein.

[0084] like Figure 7 As shown, the electronic device 300 may include a processor (e.g., a central processing unit, a graphics processing unit, etc.) 301, which can perform various appropriate actions and processes according to a program stored in a read-only memory (ROM) 302 or a program loaded from a memory 308 into a random access memory (RAM) 303. The RAM 303 also stores various programs and data required for the operation of the electronic device 300. The processor 301, ROM 302, and RAM 303 are interconnected via a bus 304. An input / output (I / O) interface 305 is also connected to the bus 304.

[0085] Typically, the following devices can be connected to I / O interface 305: input devices 306 including, for example, touchscreens, touchpads, keyboards, mice, cameras, microphones, accelerometers, gyroscopes, etc.; output devices 307 including, for example, liquid crystal displays (LCDs), speakers, vibrators, etc.; memory devices 308 including, for example, magnetic tapes, hard disks, etc.; and communication devices 309. Communication device 309 allows electronic device 300 to communicate wirelessly or wiredly with other devices to exchange data. Although Figure 7 An electronic device 300 with various devices is shown; however, it should be understood that it is not required to implement or possess all of the devices shown. More or fewer devices may be implemented or possessed alternatively.

[0086] In particular, according to embodiments of this disclosure, the processes described above with reference to the flowcharts can be implemented as computer software programs. For example, embodiments of this disclosure include a computer program product comprising a computer program carried on a non-transitory computer-readable medium, the computer program containing program code for performing the methods shown in the flowcharts. In such embodiments, the computer program can be downloaded and installed from a network via a communication device 309, or installed from a memory 308, or installed from a ROM 302. When the computer program is executed by the processor 301, it performs the functions defined in the electromagnetic synchronous stimulation control method of embodiments of this disclosure.

[0087] It should be noted that the computer-readable medium described in this disclosure can be a computer-readable signal medium or a computer-readable storage medium, or any combination thereof. A computer-readable storage medium can be, for example,—but not limited to—an electrical, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, or device, or any combination thereof. More specific examples of a computer-readable storage medium may include, but are not limited to: an electrical connection having one or more wires, a portable computer disk, a hard disk, random access memory (RAM), read-only memory (ROM), erasable programmable read-only memory (EPROM or flash memory), optical fiber, portable compact disk read-only memory (CD-ROM), optical storage device, magnetic storage device, or any suitable combination thereof. In this disclosure, a computer-readable storage medium can be any tangible medium containing or storing a program that can be used by or in conjunction with an instruction execution system, apparatus, or device. In this disclosure, a computer-readable signal medium can include a data signal propagated in baseband or as part of a carrier wave, carrying computer-readable program code. Such propagated data signals can take various forms, including but not limited to electromagnetic signals, optical signals, or any suitable combination thereof. A computer-readable signal medium can be any computer-readable medium other than a computer-readable storage medium, which can send, propagate, or transmit a program for use by or in connection with an instruction execution system, apparatus, or device. The program code contained on the computer-readable medium can be transmitted using any suitable medium, including but not limited to: wires, optical fibers, RF (radio frequency), etc., or any suitable combination thereof.

[0088] In some implementations, clients and servers can communicate using any currently known or future-developed network protocol such as HTTP (Hypertext Transfer Protocol) and can interconnect with digital data communication (e.g., communication networks) of any form or medium. Examples of communication networks include local area networks (“LANs”), wide area networks (“WANs”), the Internet (e.g., the Internet of Things), and peer-to-peer networks (e.g., ad hoc peer-to-peer networks), as well as any currently known or future-developed networks.

[0089] The aforementioned computer-readable medium may be included in the aforementioned electronic device; or it may exist independently and not assembled into the electronic device.

[0090] The aforementioned computer-readable medium carries one or more programs, which, when executed by the electronic device, cause the electronic device to perform the aforementioned electromagnetic synchronous stimulation control method.

[0091] Electronic devices can be programmed with computer program code in one or more programming languages ​​or combinations thereof to perform the operations of this disclosure. These programming languages ​​include, but are not limited to, object-oriented programming languages ​​such as Java, Smalltalk, and C++, as well as conventional procedural programming languages ​​such as "C" or similar languages. The program code can be executed entirely on the user's computer, partially on the user's computer, as a standalone software package, partially on the user's computer and partially on a remote computer, or entirely on a remote computer or server. In cases involving remote computers, the remote computer can be connected to the user's computer via any type of network—including a local area network (LAN) or a wide area network (WAN)—or can be connected to an external computer (e.g., via the Internet using an Internet service provider).

[0092] The flowcharts and block diagrams in the accompanying drawings illustrate the architecture, functionality, and operation of possible implementations of systems, methods, and computer program products according to various embodiments of this disclosure. In this regard, each block in a flowchart or block diagram may represent a module, segment, or portion of code containing one or more executable instructions for implementing a specified logical function. It should also be noted that in some alternative implementations, the functions indicated in the blocks may occur in a different order than those indicated in the drawings. For example, two consecutively indicated blocks may actually be executed substantially in parallel, and they may sometimes be executed in reverse order, depending on the functions involved. It should also be noted that each block in the block diagrams and / or flowcharts, and combinations of blocks in the block diagrams and / or flowcharts, can be implemented using a dedicated hardware-based system that performs the specified function or operation, or using a combination of dedicated hardware and computer instructions.

[0093] The units described in the embodiments of this disclosure can be implemented in software or hardware. The names of the units are not, in some cases, intended to limit the specific unit.

[0094] The functions described above in this document can be performed at least in part by one or more hardware logic components. For example, exemplary types of hardware logic components that can be used, without limitation, include: field-programmable gate arrays (FPGAs), application-specific integrated circuits (ASICs), application-specific standard products (ASSPs), system-on-a-chip (SoCs), complex programmable logic devices (CPLDs), and so on.

[0095] In the context of this disclosure, a machine-readable medium can be a tangible medium that may contain or store a program for use by or in conjunction with an instruction execution system, apparatus, or device. A machine-readable medium can be a machine-readable signal medium or a machine-readable storage medium. A machine-readable medium can be, but is not limited to, electronic, magnetic, optical, electromagnetic, infrared, or semiconductor systems, apparatus, or devices, or any suitable combination of the foregoing. More specific examples of machine-readable storage media include electrical connections based on one or more wires, portable computer disks, hard disks, random access memory (RAM), read-only memory (ROM), erasable programmable read-only memory (EPROM or flash memory), optical fiber, portable compact disk read-only memory (CD-ROM), optical storage devices, magnetic storage devices, or any suitable combination of the foregoing.

[0096] The above description is merely a preferred embodiment of this disclosure and an explanation of the technical principles employed. Those skilled in the art should understand that the scope of this disclosure is not limited to technical solutions formed by specific combinations of the above-described technical features, but should also cover other technical solutions formed by arbitrary combinations of the above-described technical features or their equivalents without departing from the above-described concept. For example, technical solutions formed by substituting the above features with (but not limited to) technical features disclosed in this disclosure that have similar functions.

[0097] Furthermore, while the operations are described in a specific order, this should not be construed as requiring these operations to be performed in the specific order shown or in a sequential order. In certain environments, multitasking and parallel processing may be advantageous. Similarly, while several specific implementation details are included in the above discussion, these should not be construed as limiting the scope of this disclosure. Certain features described in the context of individual embodiments may also be implemented in combination in a single embodiment. Conversely, various features described in the context of a single embodiment may also be implemented individually or in any suitable sub-combination in multiple embodiments.

[0098] Although the subject matter has been described using language specific to structural features and / or methodological logic, it should be understood that the subject matter defined in the appended claims is not necessarily limited to the specific features or actions described above. Rather, the specific features and actions described above are merely illustrative examples of implementing the claims.

Claims

1. An electromagnetic synchronous stimulation control device, characterized in that, include: The target information generation module is configured to acquire multimodal data of neurophysiology and imaging of the target object, perform fusion analysis on the multimodal data through a preset localization algorithm, determine the spatial location of the epileptogenic focus origin region in the cerebral cortex, map the spatial location to the scalp coordinate system, and generate target location information. The stimulation parameter configuration module is configured to acquire a preset individualized stimulation parameter template, and based on the stimulation parameter template and the target location information, generate a combined stimulation scheme data package containing the placement position of the cathode stimulation electrode, the focusing position of the magnetic field stimulation coil, the transcranial direct current stimulation parameters, and the repetitive transcranial magnetic stimulation parameters. The synchronous control instruction generation module is configured to parse the combined stimulation scheme data packet, generate a first timing control signal for controlling the transcranial direct current stimulation unit and a second timing control signal for controlling the repetitive transcranial magnetic stimulation unit, and keep the first timing control signal and the second timing control signal synchronously overlapped on the time axis. The stimulation execution and feedback module is configured to send the first timing control signal to the transcranial direct current stimulation unit, send the second timing control signal to the repetitive transcranial magnetic stimulation unit, drive the transcranial direct current stimulation unit and the repetitive transcranial magnetic stimulation unit to synchronously apply physical stimulation to the target location, and simultaneously collect the electroencephalogram (EEG) signal of the target object in real time and generate a stimulation execution log.

2. The apparatus according to claim 1, characterized in that, The target information generation module is specifically configured as follows: The brain region extent of the epileptic focus was initially determined based on video electroencephalography. Based on cranial structural magnetic resonance imaging data, the epileptogenic focus origin region was determined from the brain region. Based on magnetoencephalography source analysis and structural imaging fusion, the epileptogenic focus origin region is mapped to individualized scalp coordinates.

3. The apparatus according to claim 1, characterized in that, The stimulation parameter configuration module is specifically configured as follows: Call the preset transcranial direct current stimulation parameter table and repetitive transcranial magnetic stimulation parameter table; A first drive control word is generated based on the target scalp coordinate data and the transcranial direct current stimulation parameter table. The first drive control word includes cathode electrode channel selection, target current intensity value, stimulation duration, and electrode polarity configuration. A second drive control word is generated based on the target scalp coordinate data and the repetitive transcranial magnetic stimulation parameter table. The second drive control word includes information on magnetic stimulation coil channel selection, pulse frequency, pulse number, and stimulation intensity percentage. The first drive control word and the second drive control word are encapsulated in the same time frame and a time synchronization stamp is attached. Output the first and second drive control words with time synchronization stamps to the corresponding stimulation drivers.

4. The apparatus according to claim 1, characterized in that, The synchronization control command generation module is specifically configured as follows: The start time and end time of the first timing control signal and the second timing control signal are the same; or, The first timing control signal and the second timing control signal are controlled to have a time window that completely overlaps within the duration.

5. The apparatus according to claim 1, characterized in that, The stimulus execution and feedback module is specifically configured as follows: It extracts epileptiform discharge features from EEG signals and automatically generates stimulation pause or parameter downsampling commands in response to discharge frequency exceeding a preset threshold.

6. The apparatus according to claim 1, characterized in that, The neurophysiological and imaging multimodal data includes at least one of the following: Interictal video EEG, cranial structural MRI, and magnetoencephalography (MEG) source localization data.

7. A method for controlling electromagnetic synchronous stimulation, characterized in that, include: Multimodal data of neurophysiology and imaging of the target object are acquired, and the multimodal data are fused and analyzed by a preset localization algorithm to determine the spatial location of the epileptogenic focus origin region in the cerebral cortex. The spatial location is then mapped to the scalp coordinate system to generate target location information. Obtain a preset individualized stimulation parameter template, and based on the stimulation parameter template and the target location information, generate a combined stimulation scheme data package containing the placement position of the cathode stimulation electrode, the focusing position of the magnetic field stimulation coil, the transcranial direct current stimulation parameters, and the repetitive transcranial magnetic stimulation parameters. The combined stimulation scheme data packet is parsed to generate a first timing control signal for controlling the transcranial direct current stimulation unit and a second timing control signal for controlling the repetitive transcranial magnetic stimulation unit, and the first timing control signal and the second timing control signal are kept synchronously overlapped on the time axis. The first timing control signal is sent to the transcranial direct current stimulation unit, and the second timing control signal is sent to the repetitive transcranial magnetic stimulation unit. The transcranial direct current stimulation unit and the repetitive transcranial magnetic stimulation unit are driven to synchronously apply physical stimulation to the target location. At the same time, the electroencephalogram (EEG) signal of the target object is collected in real time, and a stimulation execution log is generated.

8. An electronic device, characterized in that, It includes a memory, a processor, and a computer program stored in the memory, wherein the processor executes the computer program to implement the steps of the method of claim 7.

9. A computer-readable storage medium, characterized in that, It stores a computer program / instruction that, when executed by a processor, implements the steps of the method of claim 7.

10. A computer program product, characterized in that, Includes a computer program / instructions that, when executed by a processor, implement the steps of the method of claim 7.

Images