Transcranial and peripheral combined magnetic stimulation treatment mode and manual intervention system

Abstract

The invention belongs to the technical field of biomedical engineering such as magnetic stimulation treatment, and discloses a system for treating nerve-related skin diseases through magnetic stimulation, in particular rosacea. The magnetic stimulation treatment system provided by the invention comprises transcranial magnetic stimulation; peripheral magnetic stimulation; the treatment frequency is high. Magnetic stimulation generates a magnetic field to stimulate nerves through an external electromagnetic coil, no operation or implantation equipment is needed, and the treatment risk and the discomfort of a patient are reduced. Compared with drug therapy, the side effect of magnetic stimulation is less and lighter, the side effect generally comprises slight discomfort or headache of scalp, and the side effect disappears rapidly after treatment. Magnetic stimulation treatment does not need anesthesia or hospitalization, the patient can immediately recover daily activities after treatment, and work and life are not affected. The stimulation intensity of magnetic stimulation can be adjusted according to the specific conditions of the patient, a personalized treatment scheme is provided, and the curative effect is improved.

Description

Technical Field

[0001] The present invention belongs to the field of biomedical engineering technology such as magnetic stimulation therapy, and specifically relates to a magnetic stimulation therapy intervention system, which is mainly used for the treatment of nerve-related skin diseases, especially rosacea. Background Art

[0002] The skin, which consists of the epidermis, dermis, and subcutaneous tissue, is the largest organ in the human body and plays a vital role in regulating homeostasis. These functions are regulated by the local neuroendocrine and immune systems, in which nerve endings release neurotransmitters, endocrine factors, neuropeptides, and cytokines, which act on corresponding receptors in a parallel, paracrine, or autocrine manner to ensure the stability and integrity of the skin. The epidermis, as the outermost layer, forms a protective barrier that relies on the differentiation of keratinocytes, the pigment system, and the synergistic effects of local neural, immune, and endocrine elements. When neuroimmune regulation is abnormal, it can lead to skin lesions, including inflammatory (such as psoriasis, atopic dermatitis, rosacea, etc.) and keratinocyte proliferative diseases (such as seborrheic keratosis and solar keratosis, etc.), adnexal structural dysfunction (such as abnormal hair follicles, eccrine glands, and sebaceous glands), hypersensitivity reactions, pigmentary diseases (such as vitiligo, chloasma, and hypopigmentation or hyperpigmentation, etc.), premature aging, and malignant tumors (such as melanoma and non-melanoma skin cancer, etc.). Maintaining normal regulation of the skin's neuroimmune system helps maintain skin integrity and prevent or improve skin lesions.

[0003] Rosacea is a chronic skin disease that mainly affects the blood vessels and hair follicles of the facial skin. The clinical manifestations of rosacea are diverse, mainly paroxysmal flushing or erythema of the skin in the center of the face (mainly the cheeks, nose, and mouth), often accompanied by papules, pustules, capillary dilation, etc., and a small number of cases may present as hypertrophic lesions. At present, both domestic and foreign views advocate personalized comprehensive treatment based on different clinical phenotypes. The main treatment methods include oral or topical medications, physical therapy, chemical peels, and surgical treatment. Internationally, only some topical medications are currently available for the treatment of facial flushing and erythema caused by rosacea. However, this treatment method is usually unable to effectively control the recurrence and aggravation of the disease.

[0004] The erythema and vascular manifestations of rosacea (such as telangiectasia) may be caused by neurovascular and immune disorders. Studies have found that rosacea, as a neurogenic disease, has increased sensory nerve density in the lesions of rosacea patients. At the same time, the triggering factors of rosacea, such as sun exposure, high temperature or cold, alcohol, spicy food or exercise, can activate peripheral sensory nerve endings, mediate the release of neuropeptides (such as substance P, calcitonin gene-related peptide, vasoactive intestinal peptide, etc.), and aggravate neurogenic inflammation. Therefore, abnormalities in peripheral sensory nerves are related to the occurrence and development of rosacea, and treatments that have a regulatory effect on neurovascular or neuroimmunity may help improve rosacea.

[0005] Studies have shown that in animal models of rosacea, abnormal activation of the primary sensory cortex is associated with the aggravation of rosacea, indicating that the occurrence and development of rosacea may also be related to abnormal behavior of specific brain regions. In a study on sensitive skin diseases, it was found that after lactic acid was used to stimulate normal people and patients with sensitive skin diseases, the patient's bilateral sensory cortex activity related to discomfort caused by stimulation increased significantly.

[0006] Magnetic stimulation therapy is a new non-invasive, painless and non-invasive treatment method that has emerged in recent years. This treatment uses a time-varying pulsed magnetic field of a certain intensity to stimulate tissues, generate an induced electric field, and then produce an exciting or inhibitory effect on nerves. Globally, magnetic stimulation has become a research hotspot that has attracted widespread attention and is used to treat many different types of diseases.

[0007] The latest research confirms that rosacea is a heat-sensitive rather than light-sensitive skin disease, which means that the conduction of thermal pain may play an important role in rosacea. Magnetic stimulation can have different effects on perception depending on the stimulation site and stimulation mode. Among them, inhibitory mode magnetic stimulation applied to the primary sensory cortex can significantly reduce pain perception and increase the pain threshold. In addition, abnormal behavior of brain regions may be related to the onset of rosacea, and magnetic stimulation can regulate the connection between neural networks by acting on local nerves, thereby affecting the function of multiple parts. These results indicate that magnetic stimulation therapy is expected to provide a new treatment for patients with refractory rosacea.

[0008] Through the above analysis, the problems and defects of the prior art are as follows:

[0009] At present, both domestic and foreign opinions advocate personalized comprehensive treatment based on different clinical phenotypes. The main treatment methods include oral or topical medications, physical therapy, chemical peels and surgical treatments. Internationally, only some topical medications can be used to treat facial flushing and erythema caused by rosacea. However, this treatment method is usually unable to effectively control the recurrence and aggravation of the disease. Summary of the invention

[0010] In view of the problems existing in the prior art, the present invention provides an artificial intervention system for treating nerve-related skin diseases by magnetic stimulation.

[0011] The present invention is implemented as follows: a magnetic stimulation treatment system for treating nerve-related skin diseases, the system comprising:

[0012] The transcranial magnetic stimulation unit is used to implement unilateral stimulation and alternately. The first round of unilateral stimulation generates 100-36,000 pulses each time. After each round of treatment, an appropriate rest time is arranged, and then the first round of transcranial magnetic stimulation is repeated for the second round, for a total of two to ten rounds of transcranial magnetic stimulation. The number and duration of treatment pulses are adjusted individually according to the individual differences of the patient.

[0013] The peripheral magnetic stimulation unit is configured to provide magnetic stimulation to the left side and right side of the patient's face respectively, wherein each side of the facial stimulation includes 100-36,000 pulses. The number and duration of treatment pulses are adjusted individually according to individual differences of the patient.

[0014] The control unit is used to control the transcranial magnetic stimulation unit and the peripheral magnetic stimulation unit to operate according to a predetermined treatment process.

[0015] The system also includes:

[0016] A pulse counter is connected to the transcranial magnetic stimulation unit and the peripheral magnetic stimulation unit to calculate and record the number of pulses for each stimulation to ensure the accuracy of the number of pulses during the treatment process;

[0017] A timer is used to control the stimulation duration and rest time of the peripheral magnetic stimulation unit.

[0018] The system also includes:

[0019] A user interface that allows the operator or patient to input treatment parameters, such as treatment frequency, stimulation intensity, etc., and displays treatment progress and status information;

[0020] The data storage unit is used to store various data during the treatment process, including the number of pulses, treatment time, patient information, etc., for subsequent analysis and evaluation of the treatment effect.

[0021] The system also includes:

[0022] A feedback system is configured to monitor the patient's physiological responses during treatment, such as skin responses, nerve responses, etc., and adjust the parameters of the magnetic stimulation according to the monitoring results to improve the safety and effectiveness of the treatment.

[0023] The present invention also provides a magnetic stimulation treatment system for treating rosacea, the system comprising:

[0024] 1. A transcranial magnetic stimulation unit, which is designed to implement unilateral stimulation and perform it alternately, each unilateral stimulation generates a preset number of pulses, such as 100-36,000 pulses, to complete the total number of pulses in one treatment cycle, and a rest time is set between each treatment cycle.

[0025] 2. A peripheral magnetic stimulation unit, the unit being configured to provide magnetic stimulation to the left side and right side of the patient's face, respectively, with each facial stimulation comprising a preset number of pulses, such as 100-36,000 pulses per side, and lasting for a preset length of time;

[0026] 3. A control unit, which is used to control the transcranial magnetic stimulation unit and the peripheral magnetic stimulation unit to operate according to a predetermined treatment process.

[0027] The system further comprises:

[0028] 1. A pulse counter, which is connected to the transcranial magnetic stimulation unit and the peripheral magnetic stimulation unit, and is used to count and record the number of pulses for each stimulation to ensure the accuracy of the number of pulses during the treatment process;

[0029] 2. A timer, which is used to control the stimulation duration and rest time of the peripheral magnetic stimulation unit to ensure the precise execution of the treatment process;

[0030] 3. User interface, which allows the operator or patient to input treatment parameters such as treatment intensity, pulse frequency, etc., and displays treatment progress and status information in real time;

[0031] 4. Data storage unit, which is used to store various data during the treatment process, including the number of pulses, treatment time, patient information, etc., for subsequent analysis and evaluation of the treatment effect.

[0032] In combination with the above technical solutions and the clinical problems solved, the advantages and positive effects of the technical solutions to be protected by the present invention are as follows:

[0033] First, in view of the technical problems existing in the above-mentioned prior art, some creative technical effects are brought about after solving the problems. The specific description is as follows:

[0034] Non-invasive: Magnetic stimulation stimulates nerves by generating a magnetic field through an external electromagnetic coil. It does not require surgery or implanted devices, reducing treatment risks and patient discomfort.

[0035] Fewer side effects: Compared with drug treatment, magnetic stimulation has fewer and milder side effects, usually including mild scalp discomfort or headache, and these side effects generally disappear quickly after treatment.

[0036] No impact on daily activities: Magnetic stimulation treatment does not require anesthesia or hospitalization. Patients can resume daily activities immediately after treatment without affecting work and life.

[0037] Personalized treatment: Magnetic stimulation can adjust the stimulation intensity according to the patient's specific situation, provide personalized treatment plans, and improve efficacy.

[0038] For refractory rosacea, there is currently a lack of effective treatments to relieve the symptoms of persistent erythema and paroxysmal flushing on the patient's face. Magnetic stimulation is expected to provide a new treatment approach for patients.

[0039] Preliminary results of the effectiveness of magnetic stimulation in the treatment of refractory rosacea:

[0040]

[0041] Second, the technical problems of the prior art solved by the present invention and the significant technical progress achieved. Problems existing in the prior art:

[0042] Rosacea is a common chronic skin disease, which is mainly manifested by facial erythema, papules and pustules, seriously affecting the patient's quality of life. At present, the treatment of rosacea mainly includes topical drug therapy, oral antibiotics, laser therapy, etc. However, these methods have some problems:

[0043] 1. Side effects: Long-term use of topical medications and oral antibiotics may lead to drug tolerance and side effects such as dry skin, allergic reactions, gastrointestinal discomfort, etc.

[0044] 2. Limited treatment effects: Some treatments (such as laser therapy) are effective in the short term, but cannot be maintained in the long term and are expensive.

[0045] 3. Obvious individual differences: Different patients have large differences in their responses to the same treatment method, making it difficult to achieve personalized treatment.

[0046] The technical solution of the present invention:

[0047] The present invention proposes a treatment system based on magnetic stimulation for treating nerve-related skin diseases, especially rosacea, which achieves effective treatment of rosacea by combining transcranial magnetic stimulation and peripheral magnetic stimulation, and has significant technical progress. The specific solution is as follows:

[0048] 1. Transcranial Magnetic Stimulation Unit

[0049] Unilateral stimulation and alternation: Unilateral stimulation and alternation are used, and each unilateral stimulation generates 100-36,000 pulses. The completion of bilateral alternating stimulation is considered a round of treatment. The entire treatment process includes two to ten rounds of treatment, and appropriate rest time is arranged after each round of treatment. The number of treatment pulses and duration are adjusted according to individual differences of the patient. This method can effectively stimulate the patient's nervous system and regulate nerve function.

[0050] 2. Peripheral Magnetic Stimulation Unit

[0051] Facial magnetic stimulation: The peripheral magnetic stimulation unit provides magnetic stimulation to the left and right sides of the patient's face, with each side receiving 100-36,000 pulses. The number of treatment pulses and duration are adjusted according to individual differences of the patient. Facial magnetic stimulation can promote blood circulation, stabilize peripheral nerve function, and improve the patient's skin health.

[0052] 3. Control unit

[0053] Predetermined treatment process: The control unit is used to control the transcranial magnetic stimulation unit and the peripheral magnetic stimulation unit to operate according to the predetermined treatment process to ensure the standardization and continuity of the treatment process.

[0054] Significant technological advancements:

[0055] 1. Small side effects: Compared with traditional drug treatment, the magnetic stimulation therapy system uses physical methods to treat without drug intervention, avoiding the side effects and drug resistance problems of drugs.

[0056] 2. Stable therapeutic effect: Through the combination of transcranial magnetic stimulation and peripheral magnetic stimulation, it can significantly relieve symptoms in the short term, and maintain the effect through long-term treatment, with a sustained and stable therapeutic effect.

[0057] 3. Personalized treatment: This system can adjust the treatment parameters (such as stimulation intensity, frequency, etc.) according to the patient's specific situation to achieve personalized treatment and meet the needs of different patients.

[0058] 4. Comprehensive monitoring and feedback: The system is equipped with a user interface, data storage unit and feedback system, which can monitor and record various data during the treatment process in real time, provide detailed treatment progress and status information, and adjust treatment parameters in real time according to the monitoring results to improve the safety and effectiveness of treatment.

[0059] 5. Easy to operate: The system is humanized in design and easy to operate, allowing the operator or patient to input treatment parameters and display treatment progress, suitable for both clinical and home environments.

[0060] Through the above technical scheme, the present invention provides an innovative magnetic stimulation treatment system, which solves the problems existing in the prior art such as large side effects, unstable treatment effects and obvious individual differences, significantly improves the treatment effect of rosacea and the quality of life of patients, and has important clinical application value and broad market prospects. BRIEF DESCRIPTION OF THE DRAWINGS

[0061] Figure 1 is a system flow chart of magnetic stimulation treatment of rosacea provided by an embodiment of the present invention;

[0062] Figure 2 is a comparison diagram of facial conditions before and after treatment provided by an embodiment of the present invention;

[0063] Figure 3 It is a comparison diagram of facial conditions before and after treatment provided by an embodiment of the present invention. DETAILED DESCRIPTION

[0064] In order to make the purpose, technical solution and advantages of the present invention more clearly understood, the present invention is further described in detail below in conjunction with the embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not used to limit the present invention.

[0065] The magnetic stimulation therapy system provided by the present invention has the following detailed working principle:

[0066] 1. Basic operation process:

[0067] At the beginning of treatment, the operator inputs treatment parameters such as treatment frequency, stimulation intensity, etc. through the user interface. The control unit coordinates the work of the transcranial magnetic stimulation unit and the peripheral magnetic stimulation unit according to these parameters and the predetermined treatment process.

[0068] 2. Working principle of transcranial magnetic stimulation unit:

[0069] The transcranial magnetic stimulation unit performs unilateral stimulation and alternation according to the instructions of the control unit. The first round of unilateral stimulation generates 100-36,000 pulses each time, alternating between the two sides, and an appropriate rest period is arranged after the stimulation, for a total of two to ten rounds. This stimulation method may have a therapeutic effect on rosacea by changing the excitability of the cerebral cortex.

[0070] 3. Working principle of peripheral magnetic stimulation unit:

[0071] The peripheral magnetic stimulation unit is configured to provide magnetic stimulation to the left and right sides of the patient's face respectively. During each treatment, each side of the face receives 100-36,000 pulses of stimulation. This process acts on the skin and related nerves through a specific magnetic field, which may help improve blood circulation and thus relieve the symptoms of rosacea.

[0072] 4. Working principle of control unit:

[0073] The control unit is the core of the entire system. It is responsible for receiving input from the user interface, generating corresponding control signals based on the input parameters and the predetermined treatment process, and sending them to the transcranial magnetic stimulation unit and the peripheral magnetic stimulation unit. At the same time, the control unit is also responsible for monitoring the entire treatment process to ensure the accuracy and safety of the treatment.

[0074] 5. Working principle of pulse counter and timer:

[0075] The pulse counter is connected to the transcranial magnetic stimulation unit and the peripheral magnetic stimulation unit to count and record the number of pulses for each stimulation. This helps to ensure the accuracy of the number of pulses during the treatment. The timer is used to control the stimulation duration and rest time of the peripheral magnetic stimulation unit to ensure the standardization and consistency of the treatment process.

[0076] 6. Working principle of user interface and data storage unit:

[0077] The user interface allows the operator or patient to input treatment parameters and displays treatment progress and status information. This makes the treatment process more intuitive and controllable. The data storage unit is used to store various data during the treatment process, such as the number of pulses, treatment time, patient information, etc. These data can be used for subsequent analysis and evaluation of treatment effects, providing a basis for optimizing treatment plans.

[0078] 7. Working principle of feedback system:

[0079] The feedback system is configured to monitor the patient's physiological reactions during treatment, such as skin reactions, nerve reactions, etc. By monitoring these physiological reactions in real time, the feedback system can detect abnormalities in a timely manner and adjust the parameters of magnetic stimulation based on the monitoring results. This helps to improve the safety and effectiveness of the treatment and ensure that patients can receive treatment in a safe and comfortable environment.

[0080] refer to Figure 1 A system for treating rosacea with magnetic stimulation provided by an embodiment of the present invention comprises:

[0081] S101, transcranial magnetic stimulation;

[0082] S102, peripheral magnetic stimulation;

[0083] S103, frequency of treatment.

[0084] The transcranial magnetic stimulation provided by the embodiment of the present invention comprises two to ten rounds in total, with each round of unilateral stimulation followed by 100-36,000 pulses and then alternating, with appropriate rest time arranged between each round.

[0085] The peripheral magnetic stimulation provided by the embodiment of the present invention: the left side and the right side of the face are stimulated 100-36000 times each.

[0086] The number and duration of magnetic stimulation therapy pulses are adjusted individually according to individual differences of the patient.

[0087] The treatment frequency provided in the embodiment of the present invention is: continuous treatment for 1-10 weeks, 5 times per week.

[0088] 1. Experimental design

[0089] The research subjects of the present invention are patients with refractory rosacea, and a randomized, controlled, double-blind clinical trial is conducted on the research subjects.

[0090] A total of 90 patients will participate in this trial, including 30 patients in the peripheral magnetic stimulation group, 30 patients in the transcranial magnetic stimulation combined with peripheral magnetic stimulation group, and 30 patients in the sham stimulation group, regardless of gender. The study period is 1-10 weeks.

[0091] Treatment options:

[0092] (1) Transcranial magnetic stimulation protocol

[0093] Stimulation target: primary sensory cortex (S1 area).

[0094] Stimulation intensity: 0-200% motor threshold.

[0095] The motor threshold was defined as the minimum stimulation energy that induced involuntary movement of the right hand abductor pollicis muscle at least 5 times out of 10 stimulations using a single pulse magnetic stimulation of the left motor cortex (M1 area).

[0096] Treatment wavelength: 0-100um

[0097] Magnetic field strength: greater than 1T

[0098] Stimulation parameters:

[0099] Theta burst stimulation mode

[0100] Frequency within cluster: 0-1000Hz

[0101] Inter-cluster frequency: 0-1000Hz

[0102] Each burst contains 3 pulses, continuous stimulation

[0103] Stimulation process: 100-36,000 pulses of unilateral stimulation were followed by alternating, and bilateral alternating stimulation was considered one round of treatment, for a total of two to ten rounds of treatment.

[0104] (2) Peripheral magnetic stimulation protocol

[0105] Stimulation target: face (surrounding the trigeminal ganglion)

[0106] Stimulation intensity: Determined according to the patient's comfort level

[0107] Stimulation parameters:

[0108] Frequency: 0-1000Hz

[0109] Treatment wavelength: 0-100um

[0110] Magnetic field strength: greater than 1T

[0111] Stimulation process: unilateral stimulation 100-36000 pulses followed by alternating

[0112] (3) Pseudo-stimulus plan:

[0113] Transcranial sham stimulation:

[0114] Adjustment method: Adjust the plane angle of the head from a 90-degree vertical position to a 45-degree oblique position.

[0115] Effect: After this angle is adjusted, the magnetic field cannot effectively penetrate the skull, but the patient can still feel the rhythmic tapping.

[0116] Other parameters: Same as those of the experimental group, including stimulation intensity, frequency, and duration.

[0117] Peripheral sham stimulation:

[0118] Equipment and parameters: The same equipment, stimulation sites, and stimulation parameters as those in the experimental group were used.

[0119] Adjustment method: Invert the coil direction vertically.

[0120] Effect: This adjustment does not induce palpable muscle contractions.

[0121] (4) Treatment steps:

[0122] Transcranial magnetic stimulation: 100-36,000 pulses of unilateral stimulation followed by alternating, and appropriate rest time after bilateral stimulation. Two to ten rounds of treatment are performed in total.

[0123] Peripheral magnetic stimulation: 100-36,000 pulses to the left side of the face, then 100-36,000 pulses to the right side of the face.

[0124] The number and duration of treatment pulses are individually adjusted according to the individual differences of the patient.

[0125] Frequency of treatment: Continuous treatment for 1-10 weeks, 5 times a week.

[0126] Among them, patients in the peripheral magnetic stimulation group received transcranial sham stimulation and peripheral magnetic stimulation treatment; patients in the transcranial combined with peripheral magnetic stimulation group received transcranial and peripheral magnetic stimulation treatment; patients in the sham stimulation group received transcranial and peripheral sham stimulation treatment.

[0127] Qualified subjects will be randomly divided into peripheral magnetic stimulation group, transcranial combined peripheral magnetic stimulation group, and sham stimulation group, and receive treatment or sham stimulation in the specified order.

[0128] 2. Inclusion and exclusion standards

[0129] Inclusion Criteria

[0130] (1) Refractory rosacea: patients who have been treated with conventional oral medications such as doxycycline for 12 weeks (or more), with or without other treatments (such as topical medications / IPL, etc.), are resistant to treatment (erythema has not decreased by 1 grade or erythema is greater than or equal to 3 degrees or symptoms such as flushing affect the quality of life (DLQI moderate and above)), or patients with frequent relapses during the 12-week treatment period;

[0131] (2) Voluntarily sign the informed consent form.

[0132] Exclusion criteria

[0133] (1) Age < 18 years old, age > 65 years old

[0134] (2) Pregnant or lactating women and those who are planning to become pregnant in the near future.

[0135] (3) Patients with rosacea and nasal hyperplasia.

[0136] (4) Patients with moderate to severe systemic diseases such as liver, kidney, lung or blood diseases.

[0137] (5) Unstable medical illness, including glaucoma, retinal detachment, or severe or recent heart attack.

[0138] (6) Abuse or dependence on alcohol or drugs in the past 3 months.

[0139] (7) History of mental illness, including history of epilepsy and electroencephalogram examination indicating epileptic-like changes.

[0140] (8) Taking medications that may lower the seizure threshold; taking antidepressants; previously or concurrently using electrotherapy, vagus nerve stimulation, or magnetic stimulation to treat other diseases.

[0141] (9) There are metal foreign bodies within 30 cm of the treatment site, such as cochlear implants, built-in pulse generators, aneurysm clips, stents, etc.; intracranial hypertension, intracranial infection; severe cardiovascular disease, especially those with pacemakers or heart stents.

[0142] (10) Patients who have been treated with topical medication within the past two weeks, or systemic medication within four weeks, or isotretinoin within three months.

[0143] (11) Combination with other facial skin diseases (such as seborrheic dermatitis, eczema, etc.) or facial manifestations of other diseases (such as dermatomyositis, systemic lupus erythematosus).

[0144] (12) Patients who are not expected to persist in follow-up.

[0145] (13) Participated in any clinical trial within one month.

[0146] (14) Other circumstances that the researcher deems inappropriate for inclusion in the study.

[0147] Elimination criteria

[0148] (1) Those who seriously violate the inclusion or exclusion criteria;

[0149] (2) The use of contraindicated drugs specified in the protocol during the trial may affect the efficacy analysis as determined by the investigator;

[0150] (3) Those who did not use the study drug;

[0151] (4) Those who were not followed up in the trial.

[0152] 3. Evaluation Methods

[0153] Main indicators

[0154] (1) Assessment of the severity of clinical symptoms of rosacea (self-assessment by patients);

[0155] (2) Assessment of the severity of clinical symptoms of rosacea (assessed by the investigator);

[0156] (3) existing skin lesion score (doctor's evaluation);

[0157] Secondary indicators

[0158] (1) Flushing score sheet (patient self-assessment);

[0159] (2) Skin Life Quality Index (DLQI) questionnaire (patient self-assessment);

[0160] (3) Anxiety and Depression Rating Scale (patient self-assessment);

[0161] (4) clinical facial photographs of patients with rosacea;

[0162] (5) VISIA photographs of the face of patients with rosacea;

[0163] (6) Safety indicators (physical examination, vital signs, routine blood and urine tests, liver and kidney function, and adverse events).

[0164] Third, the advantages and positive effects of the present invention are:

[0165] advantage:

[0166] Non-invasive: Magnetic stimulation stimulates nerves by generating a magnetic field through an external electromagnetic coil. It does not require surgery or implanted devices, reducing treatment risks and patient discomfort.

[0167] Fewer side effects: Compared with drug treatment, magnetic stimulation has fewer and milder side effects, usually including mild scalp discomfort or headache, and these side effects generally disappear quickly after treatment.

[0168] No impact on daily activities: Magnetic stimulation treatment does not require anesthesia or hospitalization. Patients can resume daily activities immediately after treatment without affecting work and life.

[0169] Personalized treatment: Magnetic stimulation can adjust the stimulation intensity according to the patient's specific situation, provide personalized treatment plans, and improve efficacy.

[0170] For refractory rosacea, there is currently a lack of effective treatments to relieve the symptoms of persistent erythema and paroxysmal flushing on the patient's face. Magnetic stimulation is expected to provide a new treatment approach for patients

[0171] Figure 1 , Figure 2 Comparison of facial condition before and after treatment.

[0172] The following is a specific application example of the magnetic stimulation treatment system described above for the treatment of rosacea:

[0173] Example 1: Personalized treatment process

[0174] Step 1: Initial Assessment

[0175] * Upon arrival at the treatment center, a professional physician will conduct an initial assessment of the patient's rosacea severity, medical history, and physiological status.

[0176] Step 2: Parameter setting

[0177] * The operator inputs the patient's personal information and treatment parameters such as treatment intensity, pulse frequency, etc. through the user interface. The system automatically sets the treatment process of the transcranial magnetic stimulation unit and the peripheral magnetic stimulation unit based on this information.

[0178] Step 3: Start treatment

[0179] *The patient sits in the treatment chair, ensuring the head and face are positioned correctly for magnetic stimulation.

[0180] *The control unit starts the treatment process, first with transcranial magnetic stimulation, then with peripheral magnetic stimulation of the left and right sides of the face.

[0181] Step 4: Real-time monitoring and adjustment

[0182] * The feedback system monitors the patient's physiological responses in real time, such as heart rate, blood pressure, etc. If any abnormal response is detected, the system will automatically adjust the parameters of the magnetic stimulation or suspend the treatment.

[0183] Step 5: End of treatment and evaluation

[0184] *After the treatment is completed, the system records and saves all the data during the treatment process. The doctor evaluates the treatment effect based on this data and makes a follow-up treatment plan for the patient.

[0185] Example 2: Remote monitoring and guidance

[0186] Step 1: Remote Assessment

[0187] * Patients undergo an initial assessment at home through a telemedicine platform, uploading photos of their rosacea and relevant medical history information.

[0188] Step 2: Remote treatment parameter settings

[0189] * The remote physician sets the treatment parameters through the telemedicine platform based on the patient's information and sends this information to the patient's magnetic stimulation treatment system.

[0190] Step 3: Patient self-help treatment

[0191] *Patients follow the remote physician's instructions and start the treatment system on their own to receive transcranial magnetic stimulation and peripheral magnetic stimulation treatments.

[0192] Step 4: Remote real-time monitoring

[0193] *During the treatment process, the system transmits the patient's physiological response data to the telemedicine platform in real time, and the physician can remotely monitor the patient's treatment status.

[0194] Step 5: Remote evaluation and feedback

[0195] *After the treatment, the remote physician will evaluate the treatment effect based on the treatment data and patient feedback, and provide the patient with follow-up treatment recommendations through the telemedicine platform.

[0196] These two embodiments demonstrate the specific application of the magnetic stimulation therapy system in the treatment of rosacea, which improves the safety and effectiveness of the treatment through personalized treatment process and remote monitoring and guidance.

[0197] The embodiments of the present invention have achieved some positive effects during the development or use process, and indeed have great advantages over the prior art. The following content is described in conjunction with data, charts, etc. of the test process.

[0198]

[0199] Preliminary results showed that there were significant differences in the effectiveness of erythema improvement after treatment: the effectiveness of the placebo group was 26.6%, the effectiveness of the peripheral magnetic stimulation group was 73.3%, and the effectiveness of the transcranial combined with peripheral magnetic stimulation group was 86.6%. In addition, the safety of the treatment method was good. Only 4 participants in the transcranial combined with peripheral magnetic stimulation group reported mild headaches after the treatment, but they were relieved after rest. The safety of peripheral magnetic stimulation treatment was good, and no adverse reactions were reported.

[0200] The above description is only a specific implementation mode of the present invention, but the protection scope of the present invention is not limited thereto. Any modifications, equivalent substitutions and improvements made by any technician familiar with the technical field within the technical scope disclosed by the present invention and within the spirit and principle of the present invention should be covered by the protection scope of the present invention.

Claims

1. A magnetic stimulation therapy system, characterized in that: The system includes: Transcranial magnetic stimulation unit, used to implement unilateral stimulation and alternate, each unilateral stimulation generates 100-36,000 pulses, and the stimulation is repeated after a certain rest time, for a total of two to ten rounds of treatment; A peripheral magnetic stimulation unit configured to provide magnetic stimulation to the left side and right side of the patient's face, respectively, with each side of the facial stimulation comprising 100-36,000 pulses; The control unit is used to control the transcranial magnetic stimulation unit and the peripheral magnetic stimulation unit to operate according to a predetermined treatment process.

2. The magnetic stimulation therapy system according to claim 1, characterized in that: The system also includes: A pulse counter is connected to the transcranial magnetic stimulation unit and the peripheral magnetic stimulation unit to calculate and record the number of pulses for each stimulation to ensure the accuracy of the number of pulses during the treatment process; A timer is used to control the stimulation duration and rest time of the peripheral magnetic stimulation unit.

3. The magnetic stimulation therapy system according to claim 2, characterized in that: The system also includes: a user interface that allows the operator or patient to input treatment parameters and displays treatment progress and status information; The data storage unit is used to store various data during the treatment process, including the number of pulses, treatment time, and patient information, so as to facilitate subsequent analysis and evaluation of the treatment effect.

4. The magnetic stimulation therapy system according to claim 3, characterized in that: The system also includes: A feedback system is configured to monitor the patient's physiological response during treatment and adjust the parameters of the magnetic stimulation based on the monitoring results to improve the safety and effectiveness of the treatment.

5. The magnetic stimulation therapy system according to claim 4, characterized in that: The magnetic field intensity and pulse frequency of the transcranial magnetic stimulation unit and the peripheral magnetic stimulation unit can be manually adjusted through the user interface to meet personalized treatment needs.

6. The magnetic stimulation therapy system according to claim 5, characterized in that: The system further comprises: a remote control module, which allows the system to be controlled and monitored via a remote device, thereby ensuring that the patient can be effectively treated in a remote situation.

7. The magnetic stimulation therapy system according to claim 6, characterized in that: The peripheral magnetic stimulation unit is designed to be adaptive to the facial contour to ensure optimal contact between the magnetic stimulation unit and the facial skin, thereby improving the treatment effect.

8. The magnetic stimulation therapy system according to any one of claims 1 to 7, used for treating nerve-related skin diseases, in particular rosacea.

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