Nerve regulation and control device and control method

Abstract

The invention relates to a nerve regulation and control device and a control method. The nerve regulation and control device is used for generating ultrasonic waves to stimulate intracranial nerves. The nerve regulation device comprises a main body and an ultrasound generating unit. The main body is configured to be suitable for being arranged on at least one of the forehead and the temples on the outer side of the head, and the ultrasonic generation unit is arranged on the main body and is configured to controllably provide ultrasonic waves to an intracranial target area. Wherein the ultrasonic generation unit is configured to provide ultrasonic waves with the frequency ranging from 0.02 MHz to 0.8 MHz into the cranium, so that the ultrasonic waves can penetrate through biological tissues with the set depth in the cranium and then reach the target area. The nerve regulation and control device and the control method provided by the invention can be widely applied to nerve regulation and control of various diseases, meanwhile, the application safety is ensured, and a new solution is provided for neuroscience research and clinical treatment.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of neuromodulation, in particular to a neuromodulation device and a control method. BACKGROUND

[0002] The treatment methods for nervous system diseases and mental diseases in the current medical field are in a key period of technological transformation. Although traditional drug therapy is widely used in clinical practice, more and more evidence shows that long-term use of nervous system drugs such as antidepressants and antiepileptic drugs can produce significant side effects, and is prone to drug dependence and tolerance problems.

[0003] In recent years, the rapidly developing neuromodulation technology provides a possibility to solve this problem, but the existing technical solutions still have obvious limitations. Invasive neuromodulation methods such as deep brain stimulation (DBS) have shown good results in the treatment of Parkinson's disease and other diseases, but due to the need for surgical implantation of electrodes, there is not only an infection risk, but also the possibility of complications such as bleeding and epilepsy. In addition, long-term maintenance and battery replacement of implanted devices also greatly reduce the acceptance and compliance of patients.

[0004] In the field of non-invasive neuromodulation technology, transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS) have become important choices. However, the spatial resolution of TMS technology in clinical application is only centimeter level, which cannot achieve precise stimulation of specific brain areas, and the effect on deep brain tissue is limited. Although tDCS can regulate neuronal excitability, it lacks precise targeted stimulation ability, and the treatment effect is often not ideal. More importantly, both of these two technologies require patients to regularly receive treatment in hospitals, making it difficult to achieve long-term home treatment and continuous intervention.

[0005] Transcranial ultrasound stimulation (TUS) as a new non-invasive neuromodulation technology has received widespread attention in recent years in the field of neuroscience research and clinical treatment. Clinical studies have shown that deep brain neuromodulation has important value in the treatment of Parkinson's disease, obsessive-compulsive disorder and other nervous system diseases, but the existing technical solutions are difficult to achieve an effective balance between penetration depth, treatment accuracy and safety. Therefore, developing a new type of transcranial ultrasound device with sufficient penetration depth and precise targeting ability has become a technical problem to be solved in the field.

[0006] Therefore, it is necessary to propose a new technical solution to overcome the shortcomings of existing technologies. Summary of the Invention

[0007] Based on this, this application provides a neuromodulation device and control method that can be widely used for neuromodulation of various diseases while ensuring the safety of the application, providing a new solution for neuroscience research and clinical treatment.

[0008] Therefore, this application adopts the following technical solution: a neuromodulation device for generating ultrasound waves to stimulate intracranial nerves, the neuromodulation device comprising:

[0009] The main body, configured to be placed at least once on the forehead and temple of the skull on the outer side of the skull; and

[0010] An ultrasound generating unit is disposed in the main body, the ultrasound generating unit being configured to controllably deliver ultrasound waves to a target area within the cranium;

[0011] The ultrasound generating unit is configured to provide ultrasound waves with a frequency of 0.02MHz to 0.8MHz into the intracranial cavity, so as to penetrate biological tissue at a set depth into the intracranial cavity and reach the target area.

[0012] In some embodiments, the ultrasound generating unit is configured such that the ultrasound waves it generates can reach the target area at a depth of 1 cm to 10 cm in biological tissue.

[0013] In some embodiments, the target region includes at least one of the prefrontal cortex, precentral gyrus, hippocampus, amygdala, hypothalamus, ventral intermediate nucleus of thalamus, and subthalamic nucleus in brain tissue.

[0014] In some embodiments, the ultrasound generating unit is configured to provide ultrasound waves with a frequency of 0.02 MHz to 0.1 MHz into the cranium; or, the ultrasound generating unit is configured to provide ultrasound waves with a frequency of 0.03 MHz to 0.06 MHz into the cranium; or, the ultrasound generating unit is configured to provide ultrasound waves with a frequency of at least one of 0.032 MHz, 0.033 MHz, 0.034 MHz, 0.035 MHz, 0.04 MHz, and 0.05 MHz into the cranium, frequencies that have been observed in clinical trials to have better population universality.

[0015] In some embodiments, the ultrasound generating unit is configured to deliver ultrasound waves with a frequency of 0.1 MHz to 0.3 MHz into the cranium.

[0016] In some embodiments, the ultrasound generating unit is configured to provide ultrasound waves with a frequency of 0.1 MHz to 0.2 MHz into the intracranial cavity; or, the ultrasound generating unit is configured to provide ultrasound waves with a frequency of 0.2 MHz to 0.3 MHz into the intracranial cavity.

[0017] In some embodiments, the ultrasonic generating unit is configured to generate ultrasonic waves with a wavelength of 5 mm to 15 mm.

[0018] In some embodiments, the neuromodulation device is configured to perform ultrasound stimulation on a target area in brain tissue associated with at least one of post-traumatic stress disorder, addictive behavior, and Parkinson's disease.

[0019] In some embodiments, the ultrasound generating unit is configured to deliver ultrasound waves at a frequency of 0.4 MHz to 0.6 MHz into the cranium.

[0020] In some embodiments, the ultrasound generating unit is configured to provide ultrasound waves with a frequency of 0.4MHz to 0.5MHz into the intracranial cavity; or, the ultrasound generating unit is configured to provide ultrasound waves with a frequency of 0.5MHz to 0.6MHz into the intracranial cavity.

[0021] In some embodiments, the ultrasound generating unit is configured such that the ultrasound waves it generates can reach the target area at a depth of 4 cm to 8 cm in biological tissue.

[0022] In some embodiments, the ultrasound generating unit is configured such that the spatial resolution of the ultrasound waves it generates is 2.5 mm to 4 mm.

[0023] In some embodiments, the neuromodulation device is configured to perform ultrasound stimulation on a target area in brain tissue associated with depression or stroke.

[0024] In some embodiments, the ultrasound generating unit is configured to deliver ultrasound waves at a frequency of 0.7 MHz to 0.8 MHz into the cranium.

[0025] In some embodiments, the ultrasound generating unit is configured such that the spatial resolution of the ultrasound waves it generates is 1 mm to 3 mm.

[0026] In some embodiments, the ultrasound generating unit is configured to generate ultrasound waves for ultrasound stimulation of a target area in the cerebral cortex, the target area of ​​the cerebral cortex including at least the precentral gyrus.

[0027] In some embodiments, the neuromodulation device is configured to perform ultrasound stimulation on target areas in brain tissue associated with chronic pain or post-stroke motor function reconstruction.

[0028] In some embodiments, the ultrasound generating unit is configured to deliver spatial peak pulses with a mean acoustic intensity of 0.1 W / cm² into the intracranial space. 2 Up to 3W / cm 2 Ultrasound.

[0029] In some embodiments, the neuromodulation device is configured to control the intracranial local temperature rise to no more than 1.5°C, the mechanical index to no more than 0.5, and the thermal index to no more than 0.7 during ultrasound stimulation.

[0030] In some embodiments, the body is a deformable component, and the ultrasonic generating unit includes a plurality of ultrasonic transducers disposed on the body.

[0031] In some embodiments, the body is a flexible sheet that conforms to the contours of the skull surface, and the plurality of ultrasonic transducers are arranged in an array on the body.

[0032] In some embodiments, the neuromodulation device includes at least one ultrasonic transducer module, the at least one ultrasonic transducer module forming an ultrasonic transducer array; the ultrasonic transducer module includes a plurality of ultrasonic transducers, a plurality of ultrasonic transducers being electrically connected in sequence to form a closed geometric shape, and at least one of the plurality of ultrasonic transducers being located at the center of the closed geometric shape.

[0033] This application also adopts the following technical solution: a control method for a neuromodulation device, the neuromodulation device comprising a main body configured to be placed on the outside of the skull and conforming to the contour of the skull surface, fitting at least one location in the forehead and temple of the skull, and an ultrasound generating unit disposed in the main body, the ultrasound generating unit being configured to controllably provide ultrasound waves to a target area within the skull; the control method comprising:

[0034] Based on the location of the target area, the ultrasonic generating unit is controlled to selectively generate ultrasonic waves with a frequency matching the location of the target area, wherein the frequency of the ultrasonic waves includes at least a portion of the frequency range from 0.03MHz to 0.8MHz, to act on the target area.

[0035] In some embodiments, the ultrasound generating unit is configured such that the ultrasound waves it generates can reach the target area at a depth of 1 cm to 10 cm in biological tissue.

[0036] In some embodiments, the target region includes at least one of the prefrontal cortex, precentral gyrus, hippocampus, amygdala, hypothalamus, ventral intermediate nucleus of thalamus, and subthalamic nucleus in brain tissue.

[0037] In some embodiments, the control method includes controlling the ultrasound generating unit to generate ultrasound waves at a frequency of 0.1 MHz to 0.3 MHz to act on the subthalamic nucleus region in neuromodulation of Parkinson's disease tremor.

[0038] In some embodiments, the neuromodulation device includes an electromyography (EMG) sensor for detecting tremor signals, and the control method includes controlling the ultrasound generating unit to generate ultrasound waves based on the tremor signals detected by the EMG sensor.

[0039] In some embodiments, the control method includes controlling the ultrasound generating unit to generate ultrasound waves with a frequency of 0.4 MHz to 0.6 MHz in neuromodulation for depression to act on the left dorsolateral prefrontal region.

[0040] In some embodiments, the control method includes controlling the ultrasound generating unit to generate ultrasound waves at a frequency of 0.7 MHz to 0.8 MHz to act on the primary somatosensory cortex region in neuromodulation for chronic pain.

[0041] The neuromodulation device provided in this application ensures effective coverage of deep brain tissue by ultrasound signals while fully complying with biosafety regulations. Through different frequency settings, the device can achieve precise stimulation and modulation of different brain depth regions. This device can be widely applied to various clinical scenarios, including mental illnesses such as depression, anxiety disorders, and schizophrenia; neurological diseases such as Parkinson's disease, Alzheimer's disease, epilepsy, and chronic pain; as well as post-stroke neurological rehabilitation, treatment of consciousness disorders, sleep regulation, intervention for addictive behaviors, and post-traumatic stress disorder (PTSD), providing a new technological solution for neuroscience research and clinical treatment. Attached Figure Description

[0042] To more clearly illustrate the technical solutions in the embodiments of this application or the conventional technology, the drawings used in the description of the embodiments or the conventional technology will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0043] Figure 1 This is a schematic diagram of the structure of an embodiment of the neural modulation device of this application.

[0044] Figure 2 This is a schematic diagram illustrating the application of the neuromodulation device of this application.

[0045] Figure 3This is a schematic diagram of the neuromodulation device of this application used for the treatment of depression.

[0046] Figure 4 This is a graph showing the changes in MEP values ​​in an embodiment of the neuromodulation device used for tremor modulation in Parkinson's disease.

[0047] Figure 5 The MADRS value variation diagram of the neuromodulation device used in the treatment of depression in this application.

[0048] Figure 6 This is a graph showing the change in pain values ​​in an embodiment of the neuromodulation device used for chronic pain management according to this application.

[0049] Figure 7 This is a schematic diagram of another embodiment of the neural modulation device of this application.

[0050] The component labels are as follows:

[0051] 1. Neural modulation device; 11. Main body; 12. Ultrasonic generating unit; 121. Ultrasonic transducer; 2. Forehead; 3. Temple; 4. Skull; 5. Brain tissue. Detailed Implementation

[0052] To make the above-mentioned objectives, features, and advantages of this application more apparent and understandable, the specific embodiments of this application are described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of this application. However, this application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of this application. Therefore, this application is not limited to the specific embodiments disclosed below.

[0053] It should be noted that when a component is referred to as being "fixed to" or "set on" another component, it can be directly on the other component or there may be an intermediate component. When a component is considered to be "connected to" another component, it can be directly connected to the other component or there may be an intermediate component present. The terms "vertical," "horizontal," "upper," "lower," "left," "right," and similar expressions used in this application's specification are for illustrative purposes only and do not represent the only possible implementation.

[0054] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this application, "multiple" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0055] In this application, unless otherwise expressly specified and limited, "above" or "below" the second feature can mean that the first feature is in direct contact with the second feature, or that the first feature and the second feature are in indirect contact through an intermediate medium. Furthermore, "above," "over," and "on top" the second feature can mean that the first feature is directly above or diagonally above the second feature, or simply indicates that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature can mean that the first feature is directly below or diagonally below the second feature, or simply indicates that the first feature is at a lower horizontal level than the second feature.

[0056] Unless otherwise defined, all technical and scientific terms used in this application have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used in this application is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. The term "and / or" as used in this application includes any and all combinations of one or more of the associated listed items.

[0057] Please see Figures 1 to 3 As shown, this application provides a neuromodulation device 1 and a control method. The neuromodulation device 1 achieves precise modulation of deep intracranial nerve target areas through non-invasive ultrasound stimulation technology, maintaining sufficient penetration depth while ensuring treatment accuracy and biosafety. The technical solution is described in detail below with reference to the accompanying drawings and specific implementation examples.

[0058] First, the overall structure and working principle of an embodiment of the neural modulation device 1 provided in this application will be briefly described.

[0059] like Figure 1 and Figure 2 As shown, the neuromodulation device 1 includes a main body 11 and an ultrasound generating unit 12. The main body 11 is configured to be placed on the outer side of the skull 4. The ultrasound generating unit 12 is disposed on the main body 11 and is configured to controllably provide ultrasound waves to a target area within the skull. It is understood that the ultrasound generating unit 12 may be connected to a control unit in a wired or wireless manner, and the control unit may control the generation of ultrasound waves. The control unit may be integrated within the neuromodulation device 1 or may be a device or equipment independent of the neuromodulation device 1. The ultrasound generating unit 12 is configured to provide ultrasound waves with a frequency of 0.02MHz to 0.8MHz into the skull, enabling it to penetrate biological tissue at a predetermined depth within the skull to reach the target area.

[0060] Specifically, in some embodiments, the main body 11 is a deformable component, such as a flexible circuit board, or a component with a flexible substrate such as rubber, silicone, woven fabric, or hydrogel that can be combined with flexible circuitry. Preferably, the main body 11 is a flexible sheet adapted to conform to the surface contour of the skull 4 and fit against the skull 4. In use, the neuromodulation device 1 is fitted tightly to the forehead 2, temples 3, and other areas as needed. The flexible main body 11 enables a stable acoustic coupling interface to be formed between the ultrasound generating unit 12 and the scalp, effectively reducing energy loss of ultrasound waves during propagation.

[0061] In this embodiment, the ultrasound generating unit 12 includes a plurality of ultrasound transducers 121 disposed on the main body 11, and the plurality of ultrasound transducers 121 are arranged in an array on the main body 11. Each ultrasound transducer 121 is made of piezoelectric ceramic or single crystal material, and its operating frequency range is between 0.02MHz and 0.8MHz. The ultrasound transducers 121 are connected by flexible circuits, so that when the main body 11 is bent, each ultrasound transducer 121 can still maintain a stable electrical connection. The ultrasound generating unit 12 is configured to generate ultrasound waves with a relatively long wavelength, which can reach the target area of ​​biological tissue at a depth of 1cm to 10cm. The target area includes at least one of the hippocampus, amygdala, hypothalamus, ventral intermediate nucleus of thalamus, and subthalamic nucleus in brain tissue. By stimulating these target areas with ultrasound, neurological or psychiatric diseases associated with these target areas can be treated or alleviated. Furthermore, the emission phase of each ultrasound transducer 121 is controlled by electronic phase control technology to form a focused ultrasound beam in the cranium. Furthermore, in some embodiments, the sound field distribution can be adjusted and optimized according to the anatomical location of the target area.

[0062] Please see Figure 7 As shown, in another embodiment, the ultrasound generating unit 12 adopts a modular, piecemeal design. Specifically, the neuromodulation device 1 includes multiple ultrasound transducer modules, which are configured to be combined in a way that can be increased or decreased in number and interchanged in position to form ultrasound transducer arrays of different shapes or sizes. Figure 7 As shown, each ultrasonic transducer module is square. It can be composed of four ultrasonic transducer modules arranged to form a square, two ultrasonic transducer modules arranged to form a rectangle, or three ultrasonic transducer modules arranged to form an L-shape or a straight line, to create different shapes to cover different areas of the skull. Furthermore, multiple ultrasonic transducer modules can be arranged close together or separately; in some embodiments, the neuromodulation device 1 may also include only one ultrasonic transducer module.

[0063] Please continue reading. Figure 7As shown, in this embodiment, each ultrasonic transducer module includes a support substrate and at least one ultrasonic transducer 121 disposed on the support substrate. In some embodiments, the neuromodulation device 1 includes at least one ultrasonic transducer module, which forms an ultrasonic transducer array. Each ultrasonic transducer module includes a plurality of ultrasonic transducers 121, wherein a plurality of ultrasonic transducers 121 are electrically connected in sequence, and their sequential connections form a closed geometric shape, with at least one ultrasonic transducer 121 located at the geometric center of this closed geometric shape. This arrangement allows multiple ultrasonic transducers 121 to surround the ultrasonic transducer 121 located at the center, which is more conducive to the concentration of ultrasonic waves and effectively targets the target area. For example, in Figure 7 In the illustrated embodiment, each ultrasonic transducer module includes five ultrasonic transducers 121, with four ultrasonic transducers 121 connected sequentially to form a rectangle, and the fifth ultrasonic transducer 121 located at the center point of this rectangle. It is understood that the number and arrangement of the ultrasonic transducers 121 are not limited to this. Furthermore, the closed geometric shape formed by the multiple ultrasonic transducers 121 can be circular, square, rectangular, rhomboid, elliptical, triangular, or other shapes. Further, if the supporting substrates of the multiple ultrasonic transducer modules are assembled into the main body 11 or mounted on the main body 11, then the supporting substrate must be made of a flexible material, or a mixture of flexible and rigid materials, thus making the main body 11 a flexible body. That is, in some embodiments, the supporting substrate of each ultrasonic transducer module can itself serve as the main body; in other embodiments, the main body 11 can also be a component independent of the ultrasonic transducer modules, with each ultrasonic transducer module connected to the main body 11.

[0064] In use, the neuromodulation device 1 can be directly attached to key brain regions such as the temple 3 (temporal window of the head) and forehead 2 (frontal lobe of the head) for non-invasive neuromodulation. The neuromodulation device 1 uses low-frequency ultrasound waves with a frequency range of 0.02MHz to 0.8MHz to stimulate intracranial tissues. The frequency range of 0.02MHz to 0.8MHz includes two endpoints: 0.02MHz and 0.8MHz. In some embodiments, the neuromodulation device 1 generates ultrasound waves with variable frequencies within the above frequency range; in other embodiments, it generates ultrasound waves with a fixed frequency within the above frequency range.

[0065] Furthermore, within the aforementioned frequency range, an adjustable spatial peak pulse mean acoustic intensity (Isppa) of 0.1 W / cm² to 3 W / cm² can cover the treatment of various neurological disorders. This combination of frequency and intensity parameters ensures effective coverage of deep brain tissue by the ultrasound signal while complying with biosafety regulations. Generally, because high-frequency ultrasound attenuates much more in tissues than low-frequency ultrasound, the initial acoustic intensity for high-frequency ultrasound applications often needs to be set higher than that for low-frequency applications to achieve the desired diagnostic or therapeutic effect, while strictly adhering to safety indices (mechanical index MI and thermal index TI). Additionally, the mechanical index MI is directly proportional to the sound pressure amplitude and inversely proportional to the square root of the frequency. This means that at the same sound pressure, the higher the frequency, the lower the mechanical index MI value, and the safer it is. In other words, while maintaining a safe mechanical index MI limit, higher sound pressure, and thus higher acoustic intensity, are permissible for high-frequency ultrasound. By setting different frequencies and acoustic intensities, precise stimulation and modulation of different depths of the brain can be achieved to treat or alleviate different types of neurological disorders.

[0066] The neuromodulation device 1 provided in one embodiment of this application integrates cutting-edge flexible electronics technology with ultrasonic neuromodulation technology. It employs a flexible main body 11 and a precisely designed array structure of ultrasonic transducers 121, overcoming the shortcomings of traditional rigid devices such as discomfort during wear, limited movement during use, easy device displacement due to user activity, and difficulty in long-term use. This neuromodulation device 1 can be widely applied to various clinical scenarios, including mental illnesses such as depression, anxiety disorders, and schizophrenia; neurological diseases such as Parkinson's disease, Alzheimer's disease, epilepsy, and chronic pain; as well as post-stroke neurological rehabilitation, treatment of consciousness disorders, sleep regulation, intervention for addictive behaviors, and post-traumatic stress disorder (PTSD), providing a novel technological solution for neuroscience research and clinical treatment.

[0067] The following details the mechanism by which ultrasound waves of different frequencies generated by the neuromodulation device 1 modulate nerves.

[0068] In some embodiments, the ultrasound generating unit 12 is configured to provide ultrasound waves with a frequency of 0.02 MHz to 0.1 MHz into the intracranial cavity. Specifically, the ultrasound generating unit is configured to provide ultrasound waves with a frequency of 0.03 MHz to 0.06 MHz into the intracranial cavity. Further, the ultrasound generating unit 12 is configured to provide ultrasound waves with frequencies of 0.032 MHz, 0.033 MHz, 0.034 MHz, 0.035 MHz, 0.04 MHz, 0.05 MHz, 0.06 MHz, 0.07 MHz, 0.08 MHz, and 0.09 MHz into the intracranial cavity.

[0069] In some embodiments, the ultrasound generating unit 12 is configured to provide ultrasound waves with a frequency of 0.1 MHz to 0.3 MHz into the cranium. The 0.1 MHz to 0.3 MHz low-frequency band has stronger tissue penetration capabilities and offers significant advantages for targeting deep brain regions. The wavelength of ultrasound waves in this band is approximately 5 mm to 15 mm, capable of penetrating 1 cm to 10 cm thick biological tissue. Its attenuation coefficient in the skull is approximately 8 dB / cm / MHz to 80 dB / cm / MHz, demonstrating excellent penetration capabilities, making it particularly suitable for targeting deep brain structures such as the amygdala, ventral intermediate nucleus of the thalamus, and subthalamic nucleus. These regions are target areas in brain tissue associated with at least one of the following conditions: PTSD, addictive behaviors, and Parkinson's disease. The association refers to the important role these target areas play in the pathological mechanisms of PTSD, addictive behaviors, and Parkinson's disease; ultrasound stimulation of these target areas can effectively alleviate or treat the corresponding conditions. In this low-frequency band, relatively high spatial peak pulse average sound intensity can be used, such as 0.8 W / cm² to 2.4 W / cm², or even 1 W / cm² to 2 W / cm², to stimulate the subthalamic nucleus and regulate abnormal discharges in the basal ganglia neural circuits, achieving effective neuromodulation while ensuring biosafety. In specific applications, the ultrasound generating unit 12 can be controlled to generate ultrasound waves with a frequency of 0.1 MHz to 0.2 MHz, or with a frequency of 0.2 MHz to 0.3 MHz. Specifically, it can be fixed-frequency ultrasound waves such as 0.1 MHz, 0.15 MHz, 0.2 MHz, 0.25 MHz, and 0.3 MHz, or variable-frequency ultrasound waves within the range of 0.1 MHz to 0.3 MHz. In some embodiments, the ultrasound generating unit is configured to provide even lower-frequency ultrasound waves into the cranium, such as ultrasound waves with a frequency of 0.03 MHz to 0.1 MHz. This low-frequency band has great potential for the treatment of deep brain diseases.

[0070] In some embodiments, the ultrasound generating unit 12 is configured to provide ultrasound waves with a frequency of 0.4 MHz to 0.6 MHz into the cranium. The mid-frequency range of 0.4 MHz to 0.6 MHz can reach target areas at a depth of 4 cm to 8 cm in biological tissue, with a spatial resolution of 2.5 mm to 4 mm, suitable for ultrasound stimulation of target areas in brain tissue 5 associated with depression or stroke. Specifically, the mid-frequency range of 0.4 MHz to 0.6 MHz provides optimal modulation of subcortical structures. The attenuation characteristics of mid-frequency ultrasound waves in the skull reduce its effective depth to 4 cm to 8 cm, corresponding to an increased spatial resolution of 2.5 mm to 4 mm. This penetration depth and spatial resolution are suitable for the therapeutic modulation of depression and the resuscitation modulation of the penumbra region associated with stroke. For example, in one embodiment, when using the neuromodulation device 1 to treat depression, the neuromodulation device 1 is attached to the forehead 2. The ultrasound generating unit 12 generates 0.5 MHz ultrasound waves that precisely act on the left dorsolateral prefrontal cortex, achieving an antidepressant effect by modulating the excitability of the prefrontal limbic system neural circuits. In practical applications, the ultrasonic generating unit 12 can be controlled to generate ultrasonic waves with a frequency of 0.4MHz to 0.5MHz, or ultrasonic waves with a frequency of 0.5MHz to 0.6MHz. Specifically, it can be ultrasonic waves with fixed frequencies such as 0.4MHz, 0.45MHz, 0.5MHz, 0.55MHz, and 0.6MHz, or ultrasonic waves with variable frequencies in the range of 0.4MHz to 0.6MHz.

[0071] In some embodiments, the ultrasound generating unit 12 is configured to provide ultrasound waves with a frequency of 0.7 MHz to 0.8 MHz into the cranium. The 0.7 MHz to 0.8 MHz high-frequency ultrasound waves have a spatial resolution of 1 mm to 3 mm, suitable for precise control of the cerebral cortex and superficial neural structures. In some embodiments, it can accurately target specific areas in the cerebral cortex, such as the precentral gyrus, making it suitable for chronic pain management and post-stroke motor function reconstruction. In specific applications, the ultrasound generating unit 12 can be controlled to generate ultrasound waves at fixed frequencies such as 0.7 MHz, 0.72 MHz, 0.74 MHz, 0.75 MHz, 0.76 MHz, 0.78 MHz, and 0.8 MHz, or to generate ultrasound waves with variable frequencies within the range of 0.7 MHz to 0.8 MHz.

[0072] Regarding the setting of sound intensity parameters, the average sound intensity of the spatial peak pulse is set to 0.1W / cm²~3W / cm², strictly adhering to the principles of biosafety and the requirements for effective neural modulation.

[0073] In some embodiments, the ultrasound generating unit 12 is configured to provide a spatial peak pulse with a mean sound intensity of 0.1 W / cm² into the intracranial space. 2 Up to 1W / cm2 Ultrasound. The low-intensity range of 0.1 W / cm² to 1 W / cm² is suitable for long-term maintenance therapy, such as continuous intervention for sleep disorders and anxiety, as it can regulate neuronal excitability without causing tissue damage. For example, in the treatment of insomnia, a frequency of 0.5 MHz combined with a sound intensity of 0.8 W / cm² is used to regulate the sleep-wake cycle by stimulating the hypothalamic sleep center. At this time, the intracranial temperature rise is controlled within 0.8℃, with a mechanical index (MI) ≤ 0.4 and a thermal index (TI) ≤ 0.6. The mechanical index (MI) is used to assess the potential risk of non-thermal biological effects (mainly cavitation) during ultrasound propagation; the higher the MI value, the greater the likelihood of cavitation. The thermal index (TI) is used to assess the potential temperature rise of tissue under ultrasound irradiation; the higher the TI value, the greater the potential risk of thermal damage to the tissue.

[0074] In other embodiments, the ultrasound generating unit 12 is configured to provide a spatial peak pulse with an average sound intensity of 1 W / cm² into the intracranial cavity. 2 Up to 2W / cm 2 Ultrasound, for example, 1.2 W / cm. 2 ~1.8W / cm 2 A moderate intensity of 1W / cm² to 2W / cm² is suitable for symptom control in the acute phase, primarily used for tremor suppression in Parkinson's disease and control of acute epileptic seizures. For example, inhibitory stimulation of the subthalamic nucleus during a Parkinson's disease tremor attack has shown in clinical studies to reduce tremor amplitude by more than 60% at this intensity. During treatment, real-time temperature monitoring is used to ensure that the local temperature rise does not exceed 1.2℃ and the MI value is maintained below 0.45.

[0075] In yet other embodiments, the ultrasound generating unit 12 is configured to provide a spatial peak pulse with a mean acoustic intensity of 2 W / cm² into the intracranial cavity. 2 Up to 3W / cm 2 Ultrasound, for example, 2.2 W / cm. 2 ~2.8W / cm 2 High-intensity ultrasound at 2W / cm² to 3W / cm² is limited to short-term use, primarily for the transient opening of the blood-brain barrier to enhance drug delivery or for suppressing acute seizures in refractory epilepsy. In these cases, infrared thermography is required to ensure that the local temperature rise does not exceed 1.5°C, and that the mechanical index (MI) is controlled below 0.5 and the thermal index (TI) is maintained below 0.7, thereby ensuring the safety of clinical application. For example, in chemotherapy for brain tumors, 2.5W / cm² ultrasound can temporarily increase blood-brain barrier permeability and promote drug delivery. In this case, the duration of a single treatment session is strictly limited to no more than 5 minutes, and real-time contrast-enhanced ultrasound imaging is used to monitor tissue response.

[0076] This application also provides a control method for a neuromodulation device 1. The neuromodulation device 1 is the neuromodulation device 1 described in the above embodiments. The control method includes: controlling the ultrasound generating unit to selectively generate ultrasound waves with frequencies matching the location of the target area, based on the location of the target area. The frequency of the ultrasound waves includes at least a portion of a frequency range from 0.02MHz to 0.8MHz, to act on the target area. In some embodiments, the neuromodulation device 1 generates ultrasound waves with frequency variations in all or part of the aforementioned frequency range. In other embodiments, the neuromodulation device 1 generates ultrasound waves with one or more fixed frequencies within the aforementioned frequency range. It should be noted that the control method can be executed by a control unit within the neuromodulation device 1, specifically, for example, a main control chip. Furthermore, control commands can be sent to the control unit by operating an external controller or terminal APP. The control commands can specifically include the frequency of the generated ultrasound waves, stimulation duration, stimulation cycle, stimulation duty cycle, and sound intensity. In some embodiments, a specific parameter combination can be pre-set, and ultrasound stimulation based on this specific parameter combination can be initiated with a single click. For example, you can set up a combination of parameters suitable for the treatment of depression through the APP and name the combination of parameters "Depression Treatment" or similar names. When depression treatment is needed, attach the neuromodulation device 1 to the appropriate position on the head, and the treatment program can be started with one click on the APP.

[0077] The following examples illustrate the application of the neuromodulation device 1 provided in this application in neuromodulation. Specifically, they illustrate the control methods of the neuromodulation device 1 provided in this application in the treatment of several different diseases.

[0078] Example 1: Tremor Modulation in Parkinson's Disease

[0079] The target area for modulating Parkinson's disease tremor is the subthalamic nucleus. In the neuromodulation of Parkinson's disease tremor, the ultrasound generator is controlled to produce a frequency of 0.1 MHz to 0.3 MHz and a spatial peak pulse average sound intensity of 0.8 to 2.4 W / cm². 2Ultrasound waves were used to target the subthalamic nucleus region. In one embodiment, a low-frequency ultrasound of 0.3 MHz was initially set as the stimulation parameter. This frequency range provides longer wavelengths and stronger tissue penetration, effectively overcoming the energy attenuation problem of conventional high-frequency ultrasound in deep brain stimulation, making it suitable for the modulation needs of the subthalamic nucleus (STN), a target located deep in the brain. The stimulation intensity (Isppa) was set within the range of 0.8–2.4 W / cm², and after rigorous in vitro tissue safety assessments and preclinical efficacy verification, effective neuromodulation effects were achieved while ensuring biosafety.

[0080] Furthermore, in some embodiments, precise regulation of characteristic tremor symptoms of Parkinson's disease is achieved by combining low-frequency deep penetration with real-time biofeedback. Specifically, the neuromodulation device 1 includes an electromyography (EMG) sensor for detecting tremor signals, and the ultrasound generating unit 12 is configured to automatically generate ultrasound waves based on the tremor signals detected by the EMG sensor. That is, the device uses an EMG signal detection triggering mechanism, integrating a highly sensitive flexible EMG sensor array in the neuromodulation device 1 to monitor the bioelectrical signals of the patient's limb tremor activity in real time. Through specific signal processing and recognition algorithms, the system can accurately capture the characteristic signals of tremor attacks and automatically trigger an ultrasound stimulation program with preset parameters when detected. This closed-loop feedback design greatly improves the accuracy and immediacy of treatment, avoiding the potential reduction in neural adaptation and energy waste caused by continuous stimulation. Furthermore, in some embodiments, the ultrasound transducer 121 array and the EMG sensor array can be integrated on the same platform using flexible electronics technology. In one embodiment, capturing the characteristic signals of tremor attacks through specific signal processing and recognition algorithms is achieved through an intelligent recognition architecture that combines improved time-frequency domain joint feature extraction with a support vector machine (SVM) classification model.

[0081] In clinical applications, rigorously designed clinical trials have demonstrated that this flexible neuromodulation device 1 can effectively suppress the characteristic resting tremor symptoms of Parkinson's disease without affecting the patient's daily activities, while maintaining excellent wearing comfort. Post-stimulation diffusion tensor imaging (DTI) showed that the ultrasound energy was precisely focused on the target STN region, and no significant increase in tissue temperature or other adverse reactions were observed in the scanned area. Figure 4The figure shows the changes in motor evoked potentials (MEPs) before and after transcranial ultrasound stimulation in a Parkinson's disease tremor patient. As can be seen from the figure, after stimulation with this device, the MEP amplitude surged from approximately 1 mV before stimulation to approximately 1.75 mV. The two asterisks indicate a P-value less than 0.01, meaning the result is significant at the 0.01 level, indicating that ultrasound stimulation effectively enhanced the neural response. In the sham stimulation control group, the MEP amplitude remained stable at around 1 mV before and after sham stimulation. The slight difference in MEP amplitude before and after sham stimulation is normal experimental error and a normal fluctuation range of human parameters. The P-value is a commonly used statistical expression, representing the probability of observing the current experimental data or more extreme data under the null hypothesis. The null hypothesis is a default, conservative assumption, usually indicating "no effect," "no difference," or "ineffective." The smaller the P-value, the less likely it is that the observed data would occur under the null hypothesis, thus providing stronger evidence to reject the null hypothesis; in this example, ultrasound stimulation has a significant effect.

[0082] Example 2: Treatment of Depression

[0083] The target area for depression treatment is the left dorsolateral prefrontal cortex (DLPFC). For example... Figure 3 As shown, in the neuromodulation for depression, a flexible neuromodulation device 1 is attached to the patient's forehead 2, controlling the ultrasound generating unit 12 to generate ultrasound waves with a frequency of 0.4MHz to 0.6MHz to act on the left dorsolateral prefrontal cortex region. During treatment, target localization is first performed, and the process involves acquiring structural brain images of the patient using a high-field magnetic resonance imaging (MRI) system. Three-dimensional reconstruction and normalization are performed based on the MNI (Montreal Neurological Institute) standard brain spatial coordinate system. A nonlinear registration algorithm based on B-spline free form deformation is used to precisely align the structural images with the standard brain atlas. Based on this, the core coordinates of the left dorsolateral prefrontal cortex are determined using automatic anatomical marking technology, and adaptive adjustments are made according to individual skull thickness and brain sulcus morphology to ensure that the energy focus point of the ultrasound stimulation corresponds to the target area with millimeter-level precision in anatomical localization. In one embodiment, the core coordinates of the left dorsolateral prefrontal cortex (DLPFC) are determined by automatic anatomical labeling technology. Specifically, this includes: constructing a multi-scale feature fusion network based on deep learning. This network first extracts local brain region anatomical features through a 3D convolutional neural network, then establishes the topological relationship between brain regions by combining graph convolutional layers, and finally achieves automatic identification of the DLPFC through a Softmax classifier. In other embodiments, other localization technologies may be used.

[0084] In terms of stimulation parameter design, in one specific embodiment, the ultrasound generating unit 12 is controlled to generate a frequency of 0.5 MHz and a spatial peak pulse average sound intensity of 1.5 W / cm². 2 The ultrasound used is intermittent ultrasound pulses, with each pulse lasting 2-8 seconds and the interval lasting 2-8 seconds. Specifically, the ultrasound frequency is set at 0.5 MHz. This parameter fully considers the balance between skull penetration depth and tissue spatial resolution. The 0.5 MHz sound wave frequency ensures sufficient penetration while maintaining good spatial focusing characteristics. The acoustic intensity parameter is set to a spatial peak pulse average sound intensity of 1.5 W / cm². This intensity range effectively induces changes in neuronal electrical activity while strictly controlling it within the biosafety threshold. The timing parameter adopts a 10 Hz intermittent pulse stimulation mode, specifically alternating between a 5-second working period and a 5-second interval. This timing arrangement considers the action potential firing characteristics of neurons while avoiding adaptive inhibition that may be caused by prolonged continuous stimulation.

[0085] The treatment protocol employs a modular implementation strategy in clinical application. It begins with a 20-minute single-stimulation test to assess individual responsiveness and tolerance. Following this, regular treatment lasts 4-6 weeks, 3-5 times per week, based on clinical evaluation results. Throughout the treatment process, the device's low-voltage drive characteristics and flexible substrate design ensure excellent wearing comfort, allowing patients to maintain normal daily activities. Clinically validated, this treatment protocol effectively improves negative emotions and cognitive function in patients with depression, with no significant adverse neurological reactions. Figure 5 The figure shows the changes in Montgomery Depression Rating Scale (MADRS) values ​​of some patients with depression during transcranial ultrasound stimulation (TCS) treatment with this device over several days. One asterisk indicates a p-value less than 0.05, meaning the result is significant at the 0.05 level. The figure shows that the MADRS values ​​generally decreased significantly with increasing treatment days. A lower MADRS value indicates a reduction in the severity of depression. In case 4, the MADRS value rebounded on days 4 and 5, which is a normal phenomenon reflecting individual differences in treatment effectiveness.

[0086] Example 3: Chronic Pain Management

[0087] The target area for chronic pain relief is the primary somatosensory cortex. In the neuromodulation of chronic pain, the ultrasound generating unit 12 is controlled to generate ultrasound waves with a frequency of 0.7MHz to 0.8MHz to act on the primary somatosensory cortex region. Specifically, for the treatment needs of various chronic pain syndromes, the primary somatosensory cortex (S1 area) of the brain is selected as the target modulation area, which plays a key central regulatory role in the perception and transmission of pain signals. In the implementation process, a three-dimensional anatomical model is first established based on the patient's individualized cranial magnetic resonance imaging data, and spatial registration is performed using standard brain atlases to accurately calibrate the coordinate position of the primary somatosensory cortex. This embodiment uses a central operating frequency of 0.8MHz. This specific frequency band has been optimized multiple times to achieve precise stimulation of the target area without causing significant skull attenuation, while effectively avoiding non-specific diffusion effects. The sound intensity parameter is set to a spatial peak pulse average sound intensity of 0.6W / cm². This intensity fully considers the optimal balance between the tissue tolerance threshold and the neuromodulation effect. Preclinical studies have confirmed that it can achieve effective analgesia without causing thermal damage. The stimulation mode employs continuous wave output, with each treatment session lasting no more than 1-20 minutes, such as 15 minutes, to ensure a good onset time window and prevent cumulative thermal effects on tissues. In practical applications, the ultrasound frequency can be adjusted within the range of 0.7MHz to 0.8MHz, and the sound intensity can be adjusted within the range of 0.1W / cm² to 1W / cm², depending on the specific circumstances.

[0088] The clinical application effect was evaluated using the internationally recognized Visual Analogue Scale (VAS) as an objective evaluation indicator. Multicenter clinical trials confirmed that this parameter combination significantly reduced patients' pain perception scores, providing an innovative non-pharmacological intervention for patients with chronic pain. Figure 6 As shown in the figure, the data corresponding to the Sham group are sham stimulation data, and the data corresponding to the dACC group are real stimulation data. It can be seen from the figure that the pain value is significantly reduced after real stimulation by the device of this application.

[0089] As described above in the specific embodiments, the neuromodulation device 1 and its control method provided in this application employ the transmission of ultrasound waves from 0.02MHz to 0.8MHz into the cranium to penetrate biological tissue at a predetermined depth and reach the target area deep within the brain. Furthermore, the relatively low frequency range within this range addresses the challenge of penetrating deep brain regions, the relatively mid-frequency range balances accuracy and depth, and the relatively high frequency range enables fine-tuning of the cortex, covering neuromodulation needs from deep nuclei to cortical circuits. Furthermore, the spatial peak pulse average acoustic intensity of the ultrasound waves is controlled within the range of 0.1W / cm² to 3W / cm², strictly adhering to FDA ultrasound equipment safety guidelines to minimize the risks of thermal and mechanical effects. Through frequency segmentation control and acoustic intensity parameter optimization, a unified approach to penetration depth, spatial resolution, and treatment safety is achieved. Additionally, the neuromodulation device 1 provided in this application combines a flexible main body 11 with an array of ultrasound transducers 121, making it comfortable to wear and conforming to the human head 4 while maintaining excellent acoustic coupling performance, suitable for home use.

[0090] In summary, the embodiments of this application have solved key problems that have long existed in the field of non-invasive neuromodulation, such as insufficient penetration depth, poor targeting, and safety concerns, through technological innovation, providing a novel solution for the treatment of nervous system diseases. With further optimization of the technology and expansion of indications, this device will become an important clinical tool in the field of neuromodulation.

[0091] The embodiments described above are merely illustrative of several implementation methods of this application, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent application. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these all fall within the scope of protection of this application. Therefore, the patent protection scope of this application should be determined by the appended claims.

Claims

1. A neuromodulation device for generating ultrasound waves to stimulate intracranial nerves, characterized in that, The neuromodulation device includes: The main body, configured to be placed at least once on the forehead and temple of the skull on the outer side of the skull; and An ultrasound generating unit is disposed in the main body, the ultrasound generating unit being configured to controllably deliver ultrasound waves to a target area within the cranium; The ultrasound generating unit is configured to provide ultrasound waves with a frequency of 0.02MHz to 0.8MHz into the intracranial cavity, so as to penetrate biological tissue at a set depth into the intracranial cavity and reach the target area.

2. The neural modulation device according to claim 1, characterized in that, The ultrasound generating unit is configured such that the ultrasound waves it generates can reach the target area at a depth of 1 cm to 10 cm in biological tissue.

3. The neural modulation device according to claim 2, characterized in that, The target area includes at least one of the following brain tissues: the prefrontal cortex, precentral gyrus, hippocampus, amygdala, hypothalamus, ventral intermediate nucleus of the thalamus, and subthalamic nucleus.

4. The neural modulation device according to claim 1, characterized in that, The ultrasound generating unit is configured to provide ultrasound waves with a frequency of 0.02MHz to 0.1MHz into the cranium.

5. The neural modulation device according to claim 4, characterized in that, The ultrasound generating unit is configured to provide ultrasound waves with a frequency of 0.03MHz to 0.06MHz into the cranium.

6. The neural modulation device according to claim 5, characterized in that, The ultrasound generating unit is configured to provide ultrasound waves with a frequency of at least one of 0.032MHz, 0.033MHz, 0.034MHz, 0.035MHz, 0.04MHz, and 0.05MHz into the intracranial cavity.

7. The neural modulation device according to claim 1, characterized in that, The ultrasound generating unit is configured to provide ultrasound waves with a frequency of 0.1 MHz to 0.3 MHz into the cranium.

8. The neural modulation device according to claim 7, characterized in that, The ultrasound generating unit is configured to provide ultrasound waves with a frequency of 0.1MHz to 0.2MHz into the cranium; Alternatively, the ultrasound generating unit is configured to provide ultrasound waves with a frequency of 0.2MHz to 0.3MHz into the cranium.

9. The neural modulation device according to claim 4, characterized in that, The ultrasonic generating unit is configured such that the wavelength of the ultrasonic waves it generates is 5mm to 15mm.

10. The neural modulation device according to claim 4, characterized in that, The neuromodulation device is configured to provide ultrasound stimulation to a target area in brain tissue associated with at least one of the following conditions: post-traumatic stress disorder, addictive behavior, and Parkinson's disease.

11. The neural modulation device according to claim 1, characterized in that, The ultrasound generating unit is configured to provide ultrasound waves with a frequency of 0.4 MHz to 0.6 MHz into the cranium.

12. The neural modulation device according to claim 11, characterized in that, The ultrasound generating unit is configured to provide ultrasound waves with a frequency of 0.4MHz to 0.5MHz into the cranium; Alternatively, the ultrasound generating unit is configured to provide ultrasound waves with a frequency of 0.5 MHz to 0.6 MHz into the cranium.

13. The neural modulation device according to claim 11, characterized in that, The ultrasound generating unit is configured such that the ultrasound waves it generates can reach the target area at a depth of 4 cm to 8 cm in biological tissue.

14. The neural modulation device according to claim 11, characterized in that, The ultrasonic generating unit is configured such that the spatial resolution of the ultrasonic waves it generates is 2.5 mm to 4 mm.

15. The neural modulation device according to claim 11, characterized in that, The neuromodulation device is configured to perform ultrasound stimulation on target areas in brain tissue associated with depression or stroke.

16. The neural modulation device according to claim 1, characterized in that, The ultrasound generating unit is configured to provide ultrasound waves with a frequency of 0.7 MHz to 0.8 MHz into the cranium.

17. The neuromodulation device according to claim 16, characterized in that, The ultrasonic generating unit is configured such that the spatial resolution of the ultrasonic waves it generates is 1mm to 3mm.

18. The neuromodulation device according to claim 16, characterized in that, The ultrasound generating unit is configured to generate ultrasound waves for ultrasound stimulation of a target area in the cerebral cortex, the target area of ​​the cerebral cortex including at least the precentral gyrus.

19. The neuromodulation device according to claim 16, characterized in that, The neuromodulation device is configured to provide ultrasound stimulation to target areas in brain tissue associated with chronic pain or post-stroke motor function reconstruction.

20. The neural modulation device according to claim 1, characterized in that, The ultrasound generating unit is configured to provide a spatial peak pulse with a mean sound intensity of 0.1 W / cm² into the intracranial cavity. 2 Up to 3W / cm 2 Ultrasound.

21. The neural modulation device according to claim 1, characterized in that, The neuromodulation device is configured to control the intracranial local temperature rise to no more than 1.5°C, the mechanical index to no more than 0.5, and the thermal index to no more than 0.7 during ultrasound stimulation.

22. The neuromodulation device according to any one of claims 1 to 21, characterized in that, The main body is a deformable component, and the ultrasonic generating unit includes multiple ultrasonic transducers disposed on the main body.

23. The neural modulation device according to claim 22, characterized in that, The main body is a flexible sheet that conforms to the contour of the skull surface, and the multiple ultrasonic transducers are arranged in an array on the main body.

24. The neuromodulation device according to any one of claims 1 to 21, characterized in that, The neural modulation device includes at least one ultrasonic transducer module, which forms an ultrasonic transducer array; each ultrasonic transducer module includes a plurality of ultrasonic transducers, which are electrically connected in sequence to form a closed geometric shape, and at least one of the ultrasonic transducers is located at the center of the closed geometric shape.

25. A control method for a neural modulation device, characterized in that, The neuromodulation device includes a main body configured to be placed on the lateral side of the skull and conform to the contours of the skull surface, fitting at least one location in the forehead and temples; and an ultrasound generating unit disposed on the main body, the ultrasound generating unit being configured to controllably deliver ultrasound waves to a target area within the skull; the control method includes: Based on the location of the target area, the ultrasonic generating unit is controlled to selectively generate ultrasonic waves with a frequency matching the location of the target area, wherein the frequency of the ultrasonic waves includes at least a portion of the frequency range from 0.02MHz to 0.8MHz, to act on the target area.

26. The control method according to claim 25, characterized in that, The ultrasound generating unit is configured such that the ultrasound waves it generates can reach the target area at a depth of 1 cm to 10 cm in biological tissue.

27. The control method according to claim 25, characterized in that, The target area includes at least one of the following brain tissues: the prefrontal cortex, precentral gyrus, hippocampus, amygdala, hypothalamus, ventral intermediate nucleus of the thalamus, and subthalamic nucleus.

28. The control method for the neural modulation device according to claim 25, characterized in that, The control method includes controlling the ultrasound generating unit to generate ultrasound waves with a frequency of 0.1 MHz to 0.3 MHz in the neuromodulation of Parkinson's disease tremor to act on the subthalamic nucleus region.

29. The control method for the neural modulation device according to claim 28, characterized in that, The neuromodulation device includes an electromyography (EMG) sensor for detecting tremor signals, and the control method includes controlling the ultrasound generating unit to generate ultrasound waves based on the tremor signals detected by the EMG sensor.

30. The control method for the neural modulation device according to claim 25, characterized in that, The control method includes: in neuromodulation targeting depression, controlling the ultrasound generating unit to generate ultrasound waves with a frequency of 0.4MHz to 0.6MHz to act on the left lateral prefrontal cortex region.

31. The control method for the neural modulation device according to claim 25, characterized in that, The control method includes: in neuromodulation for chronic pain, controlling the ultrasound generating unit to generate ultrasound waves with a frequency of 0.7 MHz to 0.8 MHz to act on the primary somatosensory cortex area.

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