A light therapy device for treating Alzheimer's disease and associated conditions

Abstract

The present application relates to a light therapy device for treating Alzheimer's disease and its associated conditions, comprising a carrying mechanism and an array of near-infrared irradiation units. The device emits near-infrared light into a containing space, and in the case of an object's head being in place, the irradiation of the emitted near-infrared light to the object's head meets a synergistic irradiation condition of an irradiation surface area ratio and an irradiation power level relative to a reference head cover surface area, the reference head cover surface area being the outer surface area of the surface of the object's head within a total boundary line, the total boundary line converging from the glabella point along the supraorbital ridge through the preauricular points on both sides, and then around the occipital protuberance to the electrode positions O1, OZ and O2 of the 10-10 international standard lead system. The irradiation surface area ratio can be as low as 30% or as high as more than 65%. The device can achieve a robust and sustained significant therapeutic effect on the treatment of AD and its associated conditions of the treatment object.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of light therapy equipment for brain and cognitive diseases, and particularly relates to a light therapy equipment for treating Alzheimer's disease and its associated diseases. BACKGROUND

[0002] Alzheimer's disease (AD) is a chronic and progressive neurodegenerative disease that mainly affects the elderly, especially people over 60 years old. The disease is characterized by memory loss, loss of social and occupational functioning, reduced executive function, speech and motor deficits, personality changes, and behavioral and psychological disorders. The deterioration process can last for 8-10 years, and currently there is no complete cure, which brings a heavy burden to families and society.

[0003] At present, the pathogenesis of AD is not completely clear, but the relatively accepted mechanism is that the abnormal processing of amyloid precursor protein (APP) produces β-amyloid protein (Aβ), which aggregates to form amyloid plaques; Tau protein is abnormally phosphorylated to form neurofibrillary tangles (NFTs), and the accumulation of these tangles in the brain leads to damage and dysfunction of nerve cells; further, intracellular NFTs and extracellular Aβ deposition will form senile plaques, resulting in increased oxidative stress, increased neuroinflammation, and mitochondrial dysfunction, etc., which further causes neuronal dysfunction and synaptic loss, and ultimately leads to neuronal death.

[0004] Long-term clinical practice has proved that the use of drugs, such as cholinesterase inhibitors, memantine, and recently introduced lumateperone (a humanized monoclonal antibody that can reduce the deposition of β-amyloid protein in the brain), combined with conventional treatment, can usually only improve mild cognitive impairment (MCI) or mild AD, and there are frequent problems of gastrointestinal adverse reactions.

[0005] In recent years, photobiomodulation (PBM) has been introduced to treat AD, which is to apply red or near-infrared light with a wavelength range of 600 to 1100 nm to the head, through the scalp and skull to the brain tissue, to treat AD non-invasively through various mechanisms, such as increasing Aβ clearance rate, reducing abnormal aggregation of Tau protein, improving metabolism and mitochondrial function, increasing cerebral blood flow, improving antioxidant stress and anti-inflammatory capacity, etc.

[0006] However, the irradiation parameters of various existing photobiomodulation equipment (also referred to as light therapy equipment herein) are defined ambiguously, chaotically and greatly different. For example, although the light power density (unit mW / cm 2) as the irradiation parameter, but the location of the action of this light power density is sometimes the immediate exit face of the LED (see Farzad Salehpour et al., Rapid Reversal of Cognitive Decline, Olfactory Dysfunction, and Quality of Life Using Multi-Modality Photobiomodulation Therapy: Case Report, Photobiomodul Photomed Laser Surg. 2019 Mar; 37(3): 159-167), sometimes a few centimeters inward from the inner wall of the head cap (see Liang Chen et al., A Pilot Study of Near-Infrared Light Treatment for Alzheimer's Disease, Journal of Alzheimer’s Disease 91 (2023) 191-201), and sometimes a depth under the dura mater (see US8308784B2). For different structures of photobiomodulation devices, even if the same light power density is present at the immediate exit face of the LED, the actual dose to the intracranial tissue will be significantly different. As shown in Fig. 1(a), the LED lamp plate is arranged in the shell of the head cap, with a predetermined distance from the head of the subject and there is a gap in the distance that will cause light attenuation; as shown in Fig. 2(a), several LED lamp plates are gathered into one irradiation unit, and the irradiation unit is tightly attached to the head of the subject; as shown in Fig. 2(b), the LED lamp plate is suspended in the air at a large distance around the head of the subject. Obviously, in these three light treatment devices, even if the immediate exit face of each LED has the same light power density, the dose to the brain tissue penetrating through the scalp and skull will be very different.

[0007] In addition, the irradiation parameter defined at the in-vivo location is not practical for the irradiation control of the light treatment device. For example, the light power density at a depth of several centimeters under the dura mater mentioned above cannot be detected invasively every time the light treatment device is operated.

[0008] Currently, manufacturers and researchers of near-infrared light treatment devices usually only simply measure and list the light power densities at different positions used as described above, and the light power densities used also vary greatly, for example, in US9993659B2, it is recorded that the light power density at the light emitting surface is about 1400mW / cm 2 to about 4200 mW / cm 2The optical power density is 31 mW / cm² at the luminescent surface, while Farzad Salehpour et al., Rapid Reversal of Cognitive Decline, Olfactory Dysfunction, and Quality of Life Using Multi-Modality Photobiomodulation Therapy: Case Report, Photobiomodul Photomed Laser Surg. 2019 Mar;37(3):159-167, recorded 31 mW / cm² at the luminescent surface. 2 The light power densities of these two devices differ by 40-140 times, yet both claim therapeutic effects on Alzheimer's disease (AD). It is perplexing to determine the appropriate light power density at what location to achieve a good therapeutic effect on AD. Does simply specifying the light power density at a particular location necessarily guarantee a good therapeutic effect on AD? Although manufacturers and researchers of near-infrared light therapy devices list power (in watts) at various locations (e.g., the emitting surface of an LED), the relationship between power and the AD treatment effect on the subject is unclear. Specifically, some of the power they use refers to the luminous power of the lamp panel, while others refer to the luminous power at the brain tissue. It is unclear whether duty cycle (time-averaged luminous power or peak luminous power) has been factored in, and the orders of magnitude differ significantly. Furthermore, US8308784B2 explicitly states that "for a selected wavelength, the power density (light intensity or power per unit area, W / cm²)..." 2 Or energy density (energy per unit area, measured in J / cm²) 2 The light energy delivered to the tissue (or power density multiplied by exposure time) is an important factor in determining the relative efficacy of phototherapy, but efficacy is not directly related to the total power or total energy delivered to the tissue (see paragraph

[0192] of its specification). Is it really true that the therapeutic efficacy of near-infrared light therapy devices for AD in subjects is not directly related to the total power or total energy delivered to the tissue?

[0009] In summary, existing technologies provide conflicting and even contradictory information regarding the required dosage for near-infrared light therapy devices, which hinders the promotion and development of near-infrared light therapy devices and methods. Summary of the Invention

[0010] The present application is proposed to solve the above problems in the prior art. The present application aims to provide a light therapy device for treating Alzheimer's disease and its associated conditions, which is not limited to a specific structure, nor to whether the near-infrared irradiation unit is a common LED or a low-energy laser diode, as long as the unified synergistic irradiation condition is met, so as to achieve robust and sustained significant therapeutic effect on the treatment of AD and its associated conditions of the subject.

[0011] According to the first aspect, the present application provides a light therapy device for treating Alzheimer's disease and its associated conditions, which comprises a bearing mechanism and an array of near-infrared irradiation units. The bearing mechanism is configured to form a containing space for the head of the subject and to bear the array of near-infrared irradiation units. The array of near-infrared irradiation units is configured to emit near-infrared light into the containing space, and in the case that the head of the subject is in place in the containing space, the irradiation of the emitted near-infrared light to the head of the subject meets the synergistic irradiation condition of the irradiation surface area ratio and the irradiation power level. Wherein, the irradiation surface area ratio is the ratio of the irradiation surface area to the reference head cover surface area, and the reference head cover surface area is the outer surface area of the surface of the head of the subject within the total boundary line. Further, the total boundary line passes through the glabella point of the head of the subject, along the brow bone, through the preauricular points on both sides, and converges backward through the inion and between the electrode positions O1, OZ and O2 of the 10-10 international standard lead system. The irradiation surface area ratio can be as low as 30% (which can be referred to as a local concentrated stimulation scheme), or as high as more than 65% (which can be referred to as a multi-zone balanced stimulation scheme).

[0012] In the present application, the so-called "irradiation to the head of the subject" is intended to mean the irradiation to the outer thin layer irradiation surface contacted by the hair of the head of the subject (the scalp where there is no hair). The energy irradiation to the outer thin layer irradiation surface means that the energy is delivered to the head including the hair, the scalp, the skull and the brain tissue. Further, the energy delivered after the absorption of the hair and the attenuation of the scalp and the skull can act on the sites in the cortex and even deeper in the brain tissue, and the energy is related to the attenuation in the transmission path.

[0013] In the present application, the so-called "time-averaged light power density" is intended to mean the light power density averaged with respect to time. For example, the "time-averaged light power density" at the target site is intended to mean the light power density averaged with respect to time at the target site. For another example, the "time-averaged light power density" of the target part is intended to mean the "time-averaged light power density" of the representative position on the target part. Specifically, the "time-averaged light power density" of the target part is 30-60 mW / cm 2 , which means that the time-averaged light power density at each representative position on the target part, such as but not limited to the position corresponding to the center of the lamp panel, is 30-60 mW / cm 2fluctuate within a range of ± 10% around 117 mW / cm

[0014] The so-called "spatiotemporal average light power density to the target region" is intended to mean the time-averaged light power density averaged with respect to the surface area of the target region, that is, the light power density after performing averaging operations with respect to both the surface area and the time.

[0015] As long as the irradiation of the emitted near-infrared light to the head of the subject satisfies the synergistic irradiation condition of the irradiation surface area ratio and the irradiation power level, for example, but not by way of limitation, for black and thick hair wearing the light guide comb described in the patent application with the application number PCT / CN2021 / 126700, or for light-colored thick hair not wearing the light guide comb, or for black and sparse hair wearing or not wearing the light guide comb, sufficient light power of near-infrared light can be delivered to sufficient regions of brain tissue per unit time. The irradiation surface area ratio of the local concentrated stimulation scheme can be as low as 30%, and an irradiation surface area ratio of more than 65% constitutes a multi-zone balanced stimulation scheme. The synergistically matched irradiation power level of the irradiation surface area ratio within this range can achieve "modulation" and "excitation" of a sufficient proportion of cell populations. After a sufficient proportion of cell populations are "modulated" and "excited", not only do they themselves respond to changes that inhibit AD, but they can also transmit and diffuse this change response to other cell populations on the AD development spatial trajectory, thereby achieving a comprehensive AD inhibition effect throughout the brain. In this way, not only can the Aβ plaques accumulated in the neocortex be significantly reduced, and the abnormal aggregation of tau proteins in the neocortex, hippocampus, and even the marginal cortex be significantly reduced, but the AD-specific lesions of cell populations throughout the brain can also be inhibited and reduced, thereby effectively inhibiting the progression of the AD course.

[0016] In some embodiments, adapted synergistic irradiation conditions can be provided for the local concentrated stimulation scheme and the multi-zone balanced stimulation scheme.

[0017] Specifically, the irradiation surface area ratio of the local concentrated stimulation scheme is less than that of the multi-zone balanced stimulation scheme, and the matched irradiation power level is also higher than that of the multi-zone balanced stimulation scheme. For example, as a local concentrated stimulation scheme, the spatiotemporal average light power density to the head of the subject is required to be 117 mW / cm 2 above when the irradiation surface area ratio is between 30% and 40%, and the spatiotemporal average light power density irradiated to the head of the subject is 110 mW / cm 2 above when the irradiation surface area ratio is between 40% and 65%. In this way, the limitations of local cell populations can be broken through, and cell populations can be fully "modulated" and "excited", and the change response to inhibit AD can be transmitted and diffused to other cell populations in a wider area on the AD development spatial trajectory.

[0018] The multi-zone balanced stimulation scheme requires an average synergistic dose of 2750 W*% to 14100 W*%, which is the product of the percentage of the irradiation surface area ratio and the average total power, so the unit is W*%, for example, if the irradiation surface area ratio is 65%, then the percentage is 65, and the average synergistic dose is the average total power multiplied by 65 W*%. As the distribution of the affected cell population is wider, such as in multiple brain regions, multiple brain function networks, etc., the above average synergistic dose is delivered to appropriately "modulate" and "stimulate" the cell population, and the inhibitory change response is transmitted and spread to other cell populations in the wide area of the AD development spatial trajectory.

[0019] Compared with the prior art, the beneficial effects of the embodiments of the present application are as follows. The light treatment device is not limited to a specific structure, nor is it limited to whether the near-infrared irradiation unit is a normal LED or a low-energy laser diode. It ensures that the near-infrared light irradiation to the head of the subject meets the synergistic irradiation condition of the irradiation surface area ratio and the irradiation power level, that is, the sufficient combined dose of the time-averaged irradiation power and the irradiation surface area ratio is delivered to the head of the subject, thereby embedding the population response characteristics of cell subpopulations and the action mechanism of brain function networks, as well as the whole-brain range progression characteristics of AD. By irradiating the sufficient combined dose of near-infrared light to the head of the subject, whether it is a local concentrated stimulation scheme or a multi-zone balanced stimulation scheme, the "modulation" and "stimulation" of the sufficient proportion of the cell population can be achieved. After the sufficient proportion of the cell population is "modulated" and "stimulated", not only does it itself undergo an inhibitory change response, but it also transmits and spreads this change response to other cell populations on the AD development spatial trajectory, thereby achieving a comprehensive AD inhibitory effect in the whole-brain range. In this way, not only can the new cortex aggregated Aβ plaques be significantly reduced, the tau protein abnormal aggregation in the new cortex, hippocampus, and even the marginal cortex can be significantly reduced, but also the AD-specific lesions of the cell population in the whole-brain range can be inhibited and reduced, thereby effectively inhibiting the progression of the AD course. The inhibitory effect of the light treatment device of the present application on the AD course is also confirmed in clinical experiments. Not only is the cognitive level of the subject significantly improved during the period of applying light therapy, but a series of biochemical reactions caused by light radiation also continue to trigger inhibitory effects during the continuous period after stopping light therapy. Not only does the inhibitory effect on AD remain to some extent, but it can even continue to improve the inhibitory effect on AD, and the cognitive level is still maintained or improved without degradation (which will be described in detail below).

[0020] It should be understood that the foregoing general description and the following detailed description are only exemplary and illustrative, but not for limiting the present application.

[0021] The foregoing general description of various implementations or examples of the technology described in this application is not a comprehensive disclosure of the full scope or all features of the disclosed technology. Attached Figure Description

[0022] In drawings that are not necessarily drawn to scale, the same reference numerals may describe similar parts in different views. The same reference numerals with or without letter suffixes may indicate different instances of similar parts. The drawings generally illustrate various embodiments by way of example rather than limitation and, together with the description and claims, serve to explain embodiments of the invention. Where appropriate, the same reference numerals are used in all drawings to refer to the same or similar parts. Such embodiments are illustrative and not intended to be exhaustive or exclusive embodiments of the apparatus or method.

[0023] Figure 1(a) shows a schematic diagram of a phototherapy device according to a first embodiment of this application;

[0024] Figure 1(b) shows a schematic diagram of the structure of the headgear of the phototherapy device according to the first embodiment of this application.

[0025] Figure 2(a) shows a schematic diagram of a phototherapy device according to a second embodiment of the present application;

[0026] Figure 2(b) shows a schematic diagram of a phototherapy device according to a third embodiment of this application.

[0027] Figures 3(a)-3(f) show schematic diagrams of the reference head model of the patient population according to embodiments of this application.

[0028] Figure 4(a) shows a front view of a reference head model as an example of a subject head according to the fourth embodiment of this application. The electrode positions of the 10-10 international standard lead system, the overall boundary line of the reference head, and the boundary lines between the upper front part of the skull, the left side of the skull, and the right side of the skull are shown on the subject head.

[0029] Figure 4(b) shows a left-side view of a reference head model as an example of an object head according to the fourth embodiment of this application. The object head shows the electrode positions of the 10-10 international standard lead system, the overall boundary line of the reference head, and the boundary lines between the upper front part of the skull, the left side of the skull, the top of the skull, and the back part of the skull.

[0030] Figure 4(c) shows a right-side view of a reference head model as an example of an object head according to the fourth embodiment of this application. The object head shows the electrode positions of the 10-10 international standard lead system, the overall boundary line of the reference head, and the boundary lines between the upper front part of the skull, the right side of the skull, the top of the skull, and the back part of the skull.

[0031] Fig. 4(d) shows a top view of the reference head model as an example of the subject's head, on which the electrode positions of the 10-10 international standard electrode system, the total boundary line of the reference head cap portion, and the boundary lines between the top of the head, the left side of the head, the right side of the head, and the back of the head are shown, according to the fourth embodiment of the present application.

[0032] Fig. 4(e) shows a back view of the reference head model as an example of the subject's head, on which the electrode positions of the 10-10 international standard electrode system, the total boundary line of the reference head cap portion, and the boundary lines between the top of the head, the left side of the head, the right side of the head, and the back of the head are shown, according to the fourth embodiment of the present application.

[0033] Fig. 5(a) shows a schematic view of the top of the head of the reference head model as an example of the subject's head, according to the fifth embodiment of the present application.

[0034] Fig. 5(b) shows a schematic view of the top of the head of the reference head model as an example of the subject's head, according to the sixth embodiment of the present application.

[0035] Fig. 5(c) shows a schematic view of the top of the head of the reference head model as an example of the subject's head, according to the seventh embodiment of the present application.

[0036] Fig. 6(a) shows an example of the irradiation area, according to the eighth embodiment of the present application.

[0037] Fig. 6(b) shows an example of the irradiation area, according to the ninth embodiment of the present application.

[0038] Fig. 6(c) shows an example of the irradiation area, according to the tenth embodiment of the present application.

[0039] Fig. 6(d) shows an example of the irradiation area, according to the eleventh embodiment of the present application.

[0040] Figure 7 Fig. 7 shows a bottom view of the headgear of the light therapy device, according to the twelfth embodiment of the present application.

[0041] Figure 8 Fig. 8 shows a schematic view of the arrangement of the light panels, according to the thirteenth embodiment of the present application.

[0042] Figure 9 Fig. 9 shows a schematic view of the arrangement of the light panel holders, according to the fourteenth embodiment of the present application.

[0043] Figure 10 Fig. 10 shows a schematic view of the procedure of a clinical experiment on AD patients using the light therapy device according to the embodiments of the present application.

[0044] FIG. 11(a) shows a graph of changes in ADAS-Cog scale scores of the control group before, during, and after the near-infrared light therapy.

[0045] FIG. 11(b) shows a graph of changes in ADAS-Cog scale scores of the test group before, during, and after the near-infrared light therapy.

[0046] FIG. 12(a) shows a graph of changes in MMSE scale scores of the control group before, during, and after the near-infrared light therapy.

[0047] FIG. 12(b) shows a graph of changes in MMSE scale scores of the test group before, during, and after the near-infrared light therapy. DETAILED DESCRIPTION

[0048] In order to make the objectives, technical solutions, and superiorities of the embodiments of the present application clearer, the technical solutions of the embodiments of the present application will be described clearly and completely below with reference to the drawings of the embodiments of the present application. Obviously, the described embodiments are some but not all of the embodiments of the present application. Based on the described embodiments of the present application, all other embodiments obtained by those of ordinary skill in the art without creative effort fall within the scope of the present application.

[0049] Unless otherwise defined, technical terms or scientific terms used in the present application shall have the ordinary meaning commonly understood by those of ordinary skill in the art to which the present application belongs. The terms "first", "second", and similar terms used in the present application do not denote any order, quantity, or importance, but are used to distinguish different components. The terms "include", "comprise", and similar terms mean that the elements or objects before the terms encompass the elements or objects listed after the terms and their equivalents, and do not exclude other elements or objects. The terms "connected", "coupled", and similar terms do not mean only physical or mechanical connections, but can include electrical connections, whether direct or indirect. The terms "upper", "lower", "left", "right", and the like are used only to indicate relative positional relationships, and when the absolute positions of the described objects are changed, the relative positional relationships can also be changed accordingly.

[0050] In order to keep the following description of the embodiments of the present application clear and brief, the present application omits detailed descriptions of known functions and known components.

[0051] The present application aims to provide a light treatment device for treating Alzheimer's disease and its associated conditions. The expression "for treating Alzheimer's disease and its associated conditions" in the present application aims to mean alleviating, inhibiting, terminating or even reversing the development of the course of Alzheimer's disease and its associated conditions. The expression "associated conditions of Alzheimer's disease" aims to mean that the subject has not yet developed the clinical symptoms of AD, but there are some pathological or physiological phenomena associated with AD and which will develop into AD with a certain probability. The expression "course of Alzheimer's disease and its associated conditions" aims to include the process in which the subject has developed the clinical symptoms of AD and then develops, and also the process in which the subject has not yet developed the clinical symptoms of AD, but there are some pathological or physiological phenomena associated with AD and which will develop into AD with a certain probability. That is, the expression "for treating Alzheimer's disease and its associated conditions" in the present application includes treating Alzheimer's disease in various courses (from MCI to severe dementia), and also treating other conditions associated with Alzheimer's disease. Specifically, according to the AD diagnostic criteria of the National Institute on Aging and the Alzheimer's Association (NIA-AA) in 2018, biomarkers can be divided into four categories based on the results of examination of β-amyloid (Aβ) and tau in the brain or cerebrospinal fluid of the population, and head MRI, FDG-PET, and cognitive function can be further divided into six levels. The first level shows normal objective cognitive neuropsychological test, no cognitive complaint, no neurobehavioral symptoms, no informed report of cognitive decline or neurobehavioral symptoms, and no follow-up test evidence of cognitive decline; the second level includes subjective cognitive decline (SCD), objective mild cognitive decline (Obj-SCD), and neurobehavioral symptoms; the first level and the second level are collectively referred to as preclinical. The third level is abnormal or impaired in objective cognitive test, but does not reach dementia, i.e. MCI. The fourth to sixth levels are mild, moderate and severe dementia, respectively. Each level in the six levels can belong to the course of Alzheimer's disease defined in the present application if there is a positive detection result of biomarkers. Further, for subjects carrying genes associated with the risk of AD but currently having a negative Aβ detection result, such as APOE ε4, ABCA7, CLU, CR1, PICALM, PLD3 and TREM2, even if the cognitive function is at the first level, medical intervention can be performed to reduce the risk of developing AD or slow down the process of developing AD, which can be considered as "treating associated conditions of Alzheimer's disease" in the present application.

[0052] The light therapy device includes a carrier mechanism 101 and an array of near-infrared irradiation units 102. The carrier mechanism 101 is configured to form an accommodation space for a subject's head 103 and to carry the array of near-infrared irradiation units 102. The array of near-infrared irradiation units 102 is configured to emit near-infrared light into the accommodation space. The carrier mechanism 101 and the array of near-infrared irradiation units 102 can take various configurations as needed, such as those shown in FIG. 1(a), FIG. 2(a), and FIG. 2(b), which will be described in detail below, but the structure of the light therapy device is not limited thereto.

[0053] When the subject's head 103 is in place in the accommodation space, the irradiation of the emitted near-infrared light to the subject's head satisfies a synergistic irradiation condition of an irradiation surface area ratio and an irradiation power level. The irradiation surface area ratio is the ratio of the irradiation surface area to the surface area of a reference head cover portion 401. As used herein, the term "in place" is intended to mean that the subject's head 103 is in a desired treatment position in the light therapy device, i.e., has a desired spatial position and spatial orientation. Generally, the light therapy device can be turned on when the subject's head 103 is in place. For example, when in place, the center of gravity of the subject's head 103 can be aligned with the center of the accommodation space, and the central axes of the front-to-back direction can be aligned with each other. For another example, when in place, the subject's head 103 can be centered in the accommodation space, with the front-to-back distance to the front and back walls of the accommodation space being substantially uniform, and the left-to-right distance to the left and right walls of the accommodation space being substantially uniform. For yet another example, with reference to the light therapy headgear shown in FIG. 1(a), when in place, the glabella of the subject's head 103 can be flush with the front edge of the headgear, and the subject's head 103 can be centered in the headgear such that the front-to-back distance to the irradiation surface of the inner shell is substantially uniform, and the left-to-right distance to the irradiation surface of the inner shell is substantially uniform.

[0054] The surface area of the reference head cover portion is the outer surface area of the subject's head surface within a total boundary line 400 that passes through the glabella of the subject's head, along the glabella, through the preauricular points on both sides, and converges rearward around the inion and between the electrode positions O1, OZ, and O2 of the 10-10 international standard electrode system, as shown in FIG. 4(a), FIG. 4(b), FIG. 4(c), and FIG. 4(e). The irradiation surface area ratio can be as low as 30% (which can be referred to as a local concentrated stimulation scheme), or as high as more than 65% (which can be referred to as a multi-zone balanced stimulation scheme).

[0055] The inventors have found, through clinical experiments including individual case experiments and experiments on a certain range of target population, that the effect of treating Alzheimer's disease and its associated conditions by irradiating near-infrared light of the same wavelength cannot be determined solely by the light power density, the irradiation power level and the irradiation surface area ratio that can be delivered to the brain tissue are important factors, and they determine the effect in a synergistic manner. Further, the energy attenuation of near-infrared light through the skull can be measured. For example, see Jagdeo JR et al. Transcranial red and near infrared light transmission in a cadaveric model. PLoS One 2012;7:e47460, at a depth of 10 mm (approximate thickness of the cadaveric skull and its complete soft tissue), the penetration percentage of 830 nm wavelength LED light is 0.9% for the temporal lobe, 2.1% for the frontal lobe, and 11.7% for the occipital lobe. In addition, the light absorption and attenuation caused by various thicknesses, amounts, and colors of hair can also be measured. That is, considering the attenuation on the transmission path from the irradiation exit surface to the target brain tissue, the near-infrared light emitted to the subject's head to meet the synergistic irradiation condition of the irradiation surface area ratio and the irradiation power level can deliver sufficient unit time light power of near-infrared light to a sufficient area of the subject's head, and then deliver sufficient unit time light power of near-infrared light after attenuation on the propagation path to a sufficient area of the brain tissue, to achieve the optimal treatment effect of Alzheimer's disease and its associated conditions. The optimization of the treatment effect is also confirmed by clinical experiments (to be described in detail below), and the light treatment device of the present application does show excellent "endurance" in the inhibition of AD progression. Specifically, the subjects not only have a significant improvement in cognitive level during the period of applying light therapy, but also maintain or improve cognitive level during the period after stopping light therapy, and the subjects have no adverse reactions. The main mechanism of this finding is estimated as follows, but the exact mechanism still needs to be confirmed and confirmed through more experiments.

[0056] AD is a whole-brain disease, and its pathological changes are not limited to a specific area of the brain, but gradually spread from some areas to the whole brain, affecting multiple brain regions and neural networks. For example, the accumulation of Aβ in the brain follows a specific spatial trajectory, starting from the default mode network (DMN) region and gradually spreading to other low-order sensory-motor regions.

[0057] Further, single-cell transcriptomic studies have revealed cell type-specific changes in AD, that is, different cell populations have different population responses associated with AD, including but not limited to Astrocytes, Microglia, Microglia, Oligodendrocytes, Neurons, Vascular Cells, Peripheral Glial Cells, Extracellular Matrix, etc. Specifically, subpopulations of Astrocytes were found to be associated with cognitive decline, which play a role in modulating the effects of tau protein on cognitive function. Different subpopulations of Microglia are associated with the pathogenesis of AD, with some subpopulations driving Abeta proteinopathy and others modulating the effects of Abeta protein on tau proteinopathy. Specific responses of Oligodendrocytes in AD are associated with disease progression, such as subpopulation-specific transcriptional changes. AD affects specific subpopulations of neurons, for example, in the hippocampus and cortical regions, which are closely associated with AD. Vascular cells, including vascular endothelial cells and perivascular cells, play a role in vascular pathology in AD. Peripheral glial cells are associated with APOE expression and play a role in neurodegeneration in AD. Changes in the extracellular matrix are also associated with the progression of AD, affecting cell-cell interactions and signaling.

[0058] As long as the irradiation of the emitted near-infrared light to the object's head meets the synergistic irradiation condition of the irradiation surface area ratio and the irradiation power level, sufficient light power of the near-infrared light can be delivered to sufficient areas of the brain tissue in unit time. The irradiation surface area ratio of the local concentrated stimulation scheme can be as low as 30%, and the irradiation surface area ratio of the multi-zone balanced stimulation scheme can be as high as more than 65%. The irradiation surface area ratios in these ranges, synergistically matched with the irradiation power levels, can achieve the "modulation" and "excitation" of sufficient proportions of cell populations. After sufficient proportions of cell populations are "modulated" and "excited", not only do they themselves respond to changes that inhibit AD, but they also transmit and spread this change response to other cell populations on the AD development spatial trajectory, thereby achieving a comprehensive AD inhibition effect throughout the brain. In this way, not only can the Aβ plaques accumulated in the neocortex be significantly reduced, and the abnormal aggregation of tau proteins in the neocortex, hippocampus, and even the marginal cortex be significantly reduced, but the AD-specific lesions of cell populations throughout the brain can also be inhibited and reduced, thereby effectively inhibiting the progression of AD and its associated conditions. Further, during the sustained period after stopping the light therapy, the series of biochemical reactions triggered by light radiation continue to trigger inhibitory effects, not only maintaining the inhibitory effect on AD to some extent, but even continuing to advance the inhibitory effect on AD without degradation.

[0059] In some embodiments, adapted synergistic irradiation conditions can be provided for the local concentrated stimulation scheme and the multi-zone balanced stimulation scheme.

[0060] Specifically, the irradiation surface area ratio of the local concentrated stimulation scheme is less than that of the multi-zone balanced stimulation scheme, and the matched irradiation power level is also higher than that of the multi-zone balanced stimulation scheme. For example, as a local concentrated stimulation scheme, the spatiotemporal average light power density required is 117 mW / cm 2 above when the irradiation surface area ratio is between 30% and 40%, and the spatiotemporal average light power density irradiated to the object's head is 110 mW / cm 2 above when the irradiation surface area ratio is between 40% and 65%. In this way, the limitations of local cell populations can be broken through, and cell populations can be fully "modulated" and "excited", transmitting and spreading the change response that inhibits AD to other cell populations in a wider area on the AD development spatial trajectory. Please note that the description of the ranges in this application is defined as follows. "Between A and B" is intended to include the percentage between A and B, but not A or B. "A to B" is intended to include the percentage between A and B, and includes both end values A and B.

[0061] The multi-region equalized stimulation protocol requires an average synergistic dose of 2750 W*% to 14100 W*%, which is the product of the irradiated surface area ratio and the average total power, so the unit is watt*percent. As the cell population affected is distributed more widely, such as in multiple brain regions, multiple brain function networks, etc., the average synergistic dose as above can be delivered to appropriately "modulate" and "excite" the cell population, and transmit and spread the inhibitory AD change response to other cell populations in a wide area on the spatial trajectory of AD development. Please note that for various synergistic irradiation conditions of the irradiated surface area ratio and the irradiation power level, the time and space average light power density irradiated to the object's head is 230 mw / cm 2 In the following, the heat damage to the tissue cells is avoided.

[0062] The light treatment device and its headgear 100 according to the first embodiment of the present application are shown in FIG. 1(a). The bearing structure 101 is configured as a head cap, which retains a proper gap with the object's head 103 when accommodated therein, so that the object's head 103 can move. This loose and open head cap design is not binding to the patient's head, and is particularly friendly to the elderly who are emotionally agitated, anxious, resistant or even fearful of closed or crowded spaces, which can significantly improve the treatment compliance of AD patients. The array 102 of near-infrared irradiation units can form a lamp panel and be fixedly mounted in the head cap.

[0063] The light treatment device can also include a user terminal 19 configured to be interacted by the user. The user terminal 19 can be configured with a computer storage medium, on which computer executable instructions are stored, which when executed by a processor, can implement various interaction steps with the user. The storage medium can include read-only memory (ROM), flash memory, random access memory (RAM), such as synchronous DRAM (SDRAM) or Rambus DRAM (DRAM), static memory (e.g., flash memory, static random access memory), etc., on which computer executable instructions can be stored in any format. In some embodiments, the user terminal 19 is also used to receive the user's confirmation operation on the proposed infrared light treatment scheme; after receiving the confirmation operation, the irradiation is performed according to the confirmed infrared light treatment scheme.

[0064] Specifically, the controller (not shown) for controlling the irradiation can be located on the user terminal 19, on the head-mounted device 100, or on a host different from the user terminal 19 and the head-mounted device 100. The controller can be implemented by various processors and can be a processing device including one or more general-purpose processing devices, such as a microprocessor, a central processing unit (CPU), a graphics processing unit (GPU), etc., or one or more special-purpose processor devices, such as an application-specific integrated circuit (ASIC), a field-programmable gate array (FPGA), a digital signal processor (DSP), a system on chip (SoC), etc. Preferably, most of the computation and processing are centralized on the user terminal 19 to reduce the computational load and the cost of software and hardware of the head-mounted device. The head-mounted device 100 is suspended on the support 20 via the elastic member 21, and the support 20 adopts a three-section free-pivot structure to facilitate flexible adjustment of the position of the head-mounted device 100. In some embodiments, the light treatment device also carries a refrigerator 23 to introduce cold air into the light treatment device to achieve sufficient and comfortable cooling around the head 103 of the subject, for example, to stabilize the temperature at about 43 degrees Celsius or even about 41 degrees Celsius.

[0065] Figure 1(b) shows an exemplary configuration of such a loose head-mounted device 100. As shown in Figure 1(b), the head-mounted device 100 is implemented as a head cap, which includes an outer shell 1, a middle shell 2, and an inner shell 3 arranged in sequence from the outside to the inside. A lamp plate accommodating cavity 4 provided with a plurality of lamp plates 5 (corresponding to the array 102 of near-infrared irradiation units in Figure 1(a)) is formed between the outer shell 1 and the middle shell 2, a cold air cavity 6 is formed between the middle shell 2 and the inner shell 3, and the inner shell 3 inwardly encloses an accommodating space. Among them, the inner shell 3 is provided with a plurality of air holes 7, so that the cold air in the cold air cavity 6 can enter the accommodating space from the air holes 7, and the air holes 7 can be provided on a first region near the top of the head and a second region below the first region of the inner shell 3. The second region is layered with a plurality of air hole units from top to bottom, wherein the arrangement of the upper air hole unit and the lower air hole unit is different, so as to cool each region of the patient's head and improve the synchronization and balance of cooling. During the light treatment process of the patient, the whole head feels more balanced temperature distribution and higher comfort.

[0066] It can be seen that the inner shell 3 is the shell layer closest to the patient's head when worn by the patient, the cold air cavity 6 is formed between the middle shell 2 and the inner shell 3, and the inner shell 3 and the middle shell 2 are arranged to be light-transmissive. In this way, the near-infrared light (for example, with a wavelength of 800-850 nm) emitted by the lamp plate 5 can sequentially pass through the light-transmissive middle shell 2 and inner shell 3 into the accommodating space to irradiate the patient's head with sufficient dose.

[0067] In some embodiments, the inner shell 3 comprises two parts, a first area close to the top of the head and a second area below the first area. The first area and the second area can be provided with air vents 7. As shown in FIG. 1(b), the middle shell 2 is provided with a cold air inlet 8 communicating with the cold air cavity 6. A ring of air vents can be provided on at least the outer edge of the first area, and a cavity can be reserved for the top of the head for the placement of a protective pad. After entering the cold air cavity 6 through the cold air inlet 8, the cold air is blown to the patient's head through the air vents 7, so that the head and the top of the head of the patient can be better cooled. In addition, the above structure can make the cold air flow from the top of the patient's head to the bottom, which is beneficial to improve the heat exchange efficiency and temperature uniformity in the containment space.

[0068] In this embodiment, the cold air inlet 8 of the cold air cavity 6 is provided in the first area and is closer to the rear of the inner shell 3 than to the front of the inner shell 3. The front of the inner shell 3 is the direction corresponding to the forehead of the headgear, and the rear of the inner shell 3 is the direction corresponding to the back of the headgear. In this way, the forehead area is not too cold, and the back of the head, which absorbs more light energy due to the large amount of hair and produces more heat, can also feel the enhanced cooling effect, thereby improving the comfort of the patient during phototherapy. This is only an example. In some embodiments, the cold air inlet 8 is kept at a close distance from the end of the front of the inner shell 3 (i.e., the edge position of the front of the inner shell 3) and the end of the rear of the inner shell 3 (i.e., the edge position of the rear of the inner shell 3) to avoid the problem of delayed and uneven cooling in the area caused by a large distance difference.

[0069] In some embodiments, in order to deliver cold air more uniformly to the containment space, the headgear can include a plurality of cold air inlets 8 distributed at different positions of the inner shell. The position of the cold air inlet 8 can be designed and adjusted according to the specific structure of the headgear and the arrangement of the light therapy lamp panel.

[0070] In some embodiments, the second area is divided into a plurality of air vent units from top to bottom. The arrangement of the upper air vent units 701 and the lower air vent units 703 is different, and the arrangement of the upper air vent units 701 and the middle air vent units 702 is the same. For example, the number of air vents of a single lower air vent unit 703 is less than that of a single upper air vent unit 701 or middle air vent unit 702. For another example, adjacent upper air vent units 701 are provided with air vents 7 having a relatively small air vent arrangement density compared to the upper air vent units 701. Such a setting allows the upper air vent units 701 and the middle air vent units 702 to release more cold air than the lower air vent units 703.

[0071] In some embodiments, the upper layer vent hole unit 701 and the middle layer vent hole unit 702 can each be composed of vent holes 7 uniformly distributed in an inner circle and vent holes 7 uniformly distributed in an outer circle. For example, 6 vent holes 7 are uniformly distributed in an inner circle and 6 vent holes 7 are uniformly distributed in an outer circle, while the lower layer vent hole unit 703 can be composed of only one circle of vent holes 7, for example, only 6 vent holes 7.

[0072] The cooling mechanism is composed of the cooling machine 23 shown in FIG. 1(a), the cold air inlet 8, the cold air cavity 6, the vent holes 7, the communication between the accommodation space and the external environment, and the like shown in FIG. 1(b). With the cooling mechanism, the temperature of the air in the space adjacent to but not in contact with the subject's head 103 does not exceed 41℃ when the time-averaged total irradiation power reaching the subject's head 103 is 27.5-120W and the single continuous irradiation duration is 30 minutes, that is, the temperature of the surrounding air in which the subject's head 103 is immersed does not exceed 41℃.

[0073] In some embodiments, the vent holes 7 are provided at least at positions corresponding to the lamp panels 5. During the light treatment of the patient, the lamp panels 5 correspondingly irradiate the skin positions of the patient, and due to the large intensity of the light irradiation, heat is more likely to be accumulated. By providing the vent holes 7 at least at the positions on the inner shell 3 corresponding to the lamp panels 5, it is possible to prevent excessive heat accumulation caused by the irradiation of the lamp panels 5 to the skin of the patient.

[0074] In some embodiments, the density of the vent holes 7 at positions corresponding to the lamp panels 5 is greater than the density of the vent holes 7 at positions not corresponding to the lamp panels 5, so as to further balance the temperature at the positions corresponding to the lamp panels 5 and other positions, enhance the air permeability of the accommodation space, and improve the air heat exchange rate in the accommodation space.

[0075] As an example, the loose head-mounted device 100 shown in FIG. 1(b) is particularly suitable for implementing a multi-zone balanced stimulation scheme. Of course, by flexible control of the lamp panels 5, the loose head-mounted device 100 can also implement a local concentrated stimulation scheme as needed.

[0076] FIG. 2(a) shows a schematic diagram of a light treatment device according to a second embodiment of the present application. As shown in FIG. 2(a), the light treatment device includes a head-mounted device 100 and a portable control terminal 104 connected in communication.

[0077] The bearing mechanism 101 adopts a hollow framework pressed against the subject's head 103, and the array 102 of near-infrared irradiation units is fixedly installed on the hollow framework. Under the action of the hollow framework, the irradiation modules are tightly attached to the forehead, the top of the head, the upper ear, and the like of the subject's head, so as to emit near-infrared light to these parts.

[0078] As an example, the control terminal 104 can be provided with operation buttons, such as but not limited to a start button, a pause button and a stop button, to facilitate the operator to control the light therapy process by pressing the buttons. The control terminal 104 can also be provided with a display to present operation information of the light therapy process to the operator, such as but not limited to the light modulation intensity and the remaining time of the current treatment, etc.

[0079] In particular, the light therapy device of the structure shown in Fig. 2(a) is especially suitable for implementing the local concentrated stimulation scheme, and / or for the treatment of the early stage of AD (e.g. during MCI, mild dementia) and for the preventive medical intervention of AD. Further, the light therapy device of the structure shown in Fig. 2(a) has good portability, which can be conveniently used by the subject at home or during travel, thereby ensuring the frequency and continuity of the light therapy.

[0080] Fig. 2(b) shows a schematic diagram of a light therapy device according to the third embodiment of the present application, the control and processing terminal of which can refer to the previous embodiments and is not shown here for simplicity of description. Unlike the head-mounted device 100 shown in Fig. 1(b) and Fig. 2(a), the carrying mechanism 101 forms a significantly wider accommodation space in the shape of an arch or an umbrella, and is further away from the head 103 of the subject. Moreover, the carrying mechanism 101 is rigidly mounted to a support or a wall, and the array 102 of near-infrared irradiation units forms a separate irradiation module mounted to the inner wall of the carrying mechanism 101.

[0081] In some embodiments, the synergistic irradiation condition of the irradiation surface area ratio and the irradiation power level can represent the correlation between the irradiation surface area ratio and the spatio-temporal average light power density, such as the synergistic irradiation condition adopted by the local concentrated stimulation scheme when the irradiation surface area ratio is between 30% to 40% or 40% to 65% as described above; or represent the product of the average total power irradiated to the head of the subject and the total irradiation surface area ratio, such as the synergistic irradiation condition adopted by the multi-zone balanced stimulation scheme when the irradiation surface area ratio is above 65% as described above. In other embodiments, the synergistic irradiation condition of the irradiation surface area ratio and the irradiation power level can adopt different definitions as needed, such as the integral of the power irradiated to each sub-zone of the head of the subject with respect to the irradiation surface area ratio of each sub-zone, or the distribution of the product of the power irradiated to each sub-zone of the head of the subject and the irradiation surface area ratio of each sub-zone, etc. The synergistic irradiation condition refined to the sub-zone distribution can more effectively identify the case where the corresponding light power or light power density of the sub-zone is too low when the irradiation dose of each brain region deviates greatly, thereby ensuring that there is no dead angle for the "modulation" and "excitation" of the cell population.

[0082] In some embodiments, the object head can include a head of a subject, or a reference head model of a subject population. The specific structure parameters of the object head mainly include head width, head length, head circumference, head sagittal arc, intertragic arc, morphological face length, and head height, as shown in FIG. 3(a)-3(f).

[0083] In order to more conveniently implement the irradiation scheme, the reference head cover of the object head is divided into a cranial anterior superior portion 401a, a cranial vertex portion 401b, a cranial left lateral portion 401c, a cranial right lateral portion 401d, and a cranial posterior portion 401e. The specific division scheme can be adjusted according to actual needs. For example, the division manner shown in FIG. 4(a)-4(e) can be used. Specifically, the division manner is based on the 10-10 international standard electrode system. The 10-10 international standard electrode system is an electrode placement standard for electroencephalogram (EEG) recording, which provides an accurate and consistent way to mark and locate electrodes on the head. That is, the 10-10 system can be directly applied to the object head without transcranial. This system is an extension of the earlier 10-20 system, which was proposed by the International Society for Electroencephalography for standardizing electrode positions in EEG recordings.

[0084] In the 10-10 system, the positions of the electrodes are located based on anatomical landmarks of the head, including the nasion, inion, and left and right pre-auricular points. Through these landmark points, the anterior-posterior and left-right midlines of the head can be determined, and then the electrodes are placed according to a 10% scale.

[0085] The naming rules of the 10-10 system are based on the 10-20 system, but provide more intensive electrode placement, especially in the bottom and front of the temporal lobe and the frontal lobe, which are often ignored in the 10-20 system. In addition, the 10-10 system also introduces some new electrodes to allow more accurate location division at the junction of brain regions, such as FC representing electrodes between the frontal central regions, FT representing electrodes between the frontal temporal regions, CP representing electrodes between the central parietal regions, and PO representing electrodes between the parietal occipital regions. The electrode placement of the 10-10 system can effectively eliminate the influence of shape and size differences of individual heads, so that the same electrode position can be basically accurately located to the same brain region node of different individuals; the more intensive electrode positions, especially for the electrode positions of the temporal lobe and the frontal lobe, can obtain more detailed division of the cranial anterior superior portion 401a, the cranial vertex portion 401b, the cranial left lateral portion 401c, the cranial right lateral portion 401d, and the cranial posterior portion 401e on the surface of the head cover (outside the skull, scalp, and hair), and accordingly more detailed division of each brain region (frontal lobe, parietal lobe, temporal lobe) under the skull and dura mater is achieved.

[0086] In some embodiments, the cranial anterior superior portion 401a, the cranial superior portion 401b, the cranial left lateral portion 401c, the cranial right lateral portion 401d, and the cranial posterior portion 401e can be defined based on their boundary lines. Referring to FIGS. 4(a)-4(e), the cranial anterior superior portion 401a is within a first region 402a enclosed by the first boundary line 400a and the total boundary line 400, which sequentially passes between the following electrode positions according to the 10-10 standard system: between F7 and FT7, between F5 and FC5, between FC3 and C3, between FC1 and C1, between FCZ and CZ, between FC2 and C2, between FC4 and C4, between F6 and FC6, and between F8 and FT8. Note that the small protrusions at the various electrode positions in FIGS. 4(a)-4(e) are only for clearer presentation of the electrode positions in this application, and actual small protrusions can not be provided. For example, the surface of the reference headform can not be provided with small protrusions, which are not described herein.

[0087] The top portion 401b is surrounded by a second boundary line 400b in a second region 402b, and the second boundary line 400b sequentially passes between the following electrode positions: between FC3 and C3, between FC1 and C1, between FCZ and CZ, between FC2 and C2, between FC4 and C4, between C6 and C4, between CP6 and CP4, between P6 and P4, between PO4 and P4, between PO4 and P2, between POZ and P2, between POZ and PZ, between POZ and P1, between PO3 and P1, between PO3 and P3, between P5 and P3, between CP5 and CP3, and between C5 and C3, according to the 10-10 standard electrode system. The left portion 401c is surrounded by a third boundary line 400c and the total boundary line 400 in a third region 402c, and the third boundary line 400c sequentially passes between the following electrode positions: between FT7 and F7, between FC5 and F5, between FC5 and FC3, between C5 and C3, between CP5 and CP3, between P5 and P3, between P5 and PO5, and between P7 and PO7, according to the 10-10 standard electrode system. The right portion 401d is surrounded by a fourth boundary line 400d and the total boundary line 400 in a fourth region 402d, and the fourth boundary line 400d sequentially passes between the following electrode positions: between FT8 and F8, between FC6 and F6, between FC6 and FC4, between C6 and C4, between CP6 and CP4, between P6 and P4, between P6 and PO6, and between P8 and PO8, according to the 10-10 standard electrode system. The back portion 401e is surrounded by a fifth boundary line 400e and the total boundary line 400 in a fifth region 402e, and the fifth boundary line 400e sequentially passes between the following electrode positions: between P7 and PO7, between P5 and PO5, between P3 and PO3, between P1 and POZ, between PZ and POZ, between P2 and POZ, between P4 and PO4, between P6 and PO6, and between P8 and PO8, according to the 10-10 standard electrode system. In the present application, the phrase "passes between electrode positions A and B" is intended to mean a point on the line connecting electrode positions A and B. For example, the point can be the midpoint of the line, or other points on the line, such as a point that is 1:2 proportionally distant from electrode positions A and B. In some embodiments, for the same boundary line, such as the fifth boundary line 400e, the points passing between pairs of electrode positions can be at different proportions on the line, so that the boundary line sequentially connected is smooth.

[0088] In some embodiments, the cranial anterior superior portion 401a, the cranial superior portion 401b, the cranial left lateral portion 401c, the cranial right lateral portion 401d, and the cranial posterior portion 401e can also be defined based on the electrode positions contained therein. Referring to FIGS. 4(a)-4(e), the cranial anterior superior portion 401a forms a region including electrode positions FP2, FPZ, FP1, AF3, AF4, AF7, AF8, AFZ, FZ, F1, F2, F3, F4, F5, F6, F7, F8, FC1, FC2, FC3, FC4, FCZ. The cranial superior portion 401b forms a region including electrode positions CZ, C1, C2, C3, C4, CPZ, CP1, CP2, CP3, CP4, PZ, P1, P2, P3, P4. The cranial left lateral portion 401c forms a region including electrode positions FT7, FC5, T7, C5, TP7, CP5, P7, P5, the cranial right lateral portion 401d forms a region including electrode positions FT8, FC6, T8, C6, TP8, CP6, P8, P6. The cranial posterior portion 401e forms a region including electrode positions PO7, PO5, PO3, POZ, PO4, P06, PO8, O1, OZ, and O2.

[0089] As an example, in FIGS. 4(a)-4(e), the cranial anterior superior portion 401a, the cranial superior portion 401b, the cranial left lateral portion 401c, the cranial right lateral portion 401d, and the cranial posterior portion 401e are contiguous with each other, without holes, and occupy the entire surface area of the reference cranial portion 401 of the subject’s head, but this is merely an example. In some embodiments, the cranial anterior superior portion 401a, the cranial superior portion 401b, the cranial left lateral portion 401c, the cranial right lateral portion 401d, and the cranial posterior portion 401e each occupy more than 70% of the surface area of the first region 402a, the second region 402b, the third region 402c, the fourth region 402d, and the fifth region 402e, respectively, demarcated by their respective boundary lines, that is, it is also possible for the proportion occupied to be as low as 70%. Irradiation of 70% of the surface area of each region, through optical diffusion of the subcranial brain tissue and conduction between the brain region nodes, achieves a comprehensive AD inhibitory effect throughout the brain.

[0090] The above demarcation manner is merely an example, and the cranial anterior superior portion 401a, the cranial superior portion 401b, the cranial left lateral portion 401c, the cranial right lateral portion 401d, and the cranial posterior portion 401e can be adjusted as needed, but preferably so that each portion mainly corresponds to the frontal lobe, the parietal lobe, the left temporal lobe, the right temporal lobe, and the occipital lobe, respectively. For example, each of the cranial anterior superior portion 401a, the cranial superior portion 401b, the cranial left lateral portion 401c, the cranial right lateral portion 401d, and the cranial posterior portion 401e can be demarcated into a plurality of island-shaped sub-regions around each group of electrode sites, as shown in FIG. 5(a). For example, each portion can also be demarcated into a whole block of connected state regions with small holes, some of which can be opened around the electrode sites, as shown in FIG. 5(b).

[0091] More preferably, the cranial anterior superior portion 401a is distributed across the frontal lobe, frontal lobe and frontal lobe-parietal lobe, as shown in Fig. 5(c). Further, the cranial superior portion 401b is distributed across the parietal lobe, parietal lobe-occipital lobe and occipital lobe, the cranial left portion 401c and the cranial right portion 401d are distributed across the frontal lobe-temporal lobe, temporal lobe, temporal lobe-parietal lobe, the cranial posterior portion 401e is distributed across the parietal lobe-occipital lobe and occipital lobe. More preferably, the cranial left portion 401c and the cranial right portion 401d are distributed across the frontal lobe-parietal lobe, temporal lobe, parietal lobe, temporal lobe-parietal lobe, parietal lobe-occipital lobe. By such distribution, each portion contains the connection sites between the brain regions, and when irradiating by portion, the connection sites between the brain regions are also fully irradiated, so that the transmission path of the "modulation" and "excitation" response of the cell population is more unobstructed.

[0092] In some embodiments, in the process of manufacturing the light treatment device, a reference head model of the population of the subjects can be used to simulate, model or test the attenuation and transmission of the near-infrared light. Specifically, a reference head model with representative size can be selected according to the population of the subjects. For example, the concentrated age of the AD patients is above 60 years old, and for the population of the subjects of this age, the parameters of the reference head model can be: head width of 140-166 mm, head length of 170-196 mm, head circumference of 525-583 mm, morphological face length of 104-130 mm, head sagittal arc of 304-372 mm, intertragus arc of 320-375 mm, head height of 206-253 mm.

[0093] Specifically, the parameter range of the reference head model falls in the intersection of the parameter value of P1, P5, P10, P50, P90, P95 and P99 of the female of this age and the parameter value of P1, P10, P50, P90, P95 and P99 of the male of this age, and thus is well representative for both the male and the female of this age.

[0094] In some embodiments, the parameters of the reference headform can be refined as follows: head width of 152 mm, head length of 184 mm, head circumference of 536.7 mm, metopic length of 109.3 mm, occipital arc of 355.6 mm, antihorizontal arc of 324.1 mm, and head height of 206 mm. At least some of the refined parameters are determined based on P50 parameter values of females in this age group and P50 parameter values of males in this age group. For example, the head width and the head length here are the average of the two corresponding P50 parameter values. The P50 parameter values of females in this age group are as follows: head width of 149 mm, head length of 180 mm, head circumference of 548 mm, metopic length of 111 mm, occipital arc of 335 mm, antihorizontal arc of 342 mm, and head height of 228 mm. The P50 parameter values of males in this age group are as follows: head width of 155 mm, head length of 188 mm, head circumference of 565 mm, metopic length of 121 mm, occipital arc of 343 mm, antihorizontal arc of 351 mm, and head height of 231 mm. It can be seen that the parameters of the reference headform have good consistency with the P50 parameters of females and males in this age group, and thus are more representative. Further, the cephalo-facial index of the parameters is 82%, which also corresponds to the range of cephalo-facial index of the dominant head type, i.e., Brachycephaly, in Chinese people (or even East Asian population). Therefore, the parameters of the reference headform have especially good representativeness in Chinese and East Asian population. In some embodiments, for other population with different cephalo-facial index, such as but not limited to the major human populations in Europe, South Asia, and Africa, the parameters can also be adjusted adaptively to have good representativeness.

[0095] The electrode positions of the 10-10 international standard coordinate system can be measured on the reference headform. In some embodiments, by adopting the above divisions of the cranial anterior superior portion 401a, the cranial top portion 401b, the cranial left portion 401c, the cranial right portion 401d, and the cranial posterior portion 401e, the simulation, modeling, or testing can be performed according to the details of the local concentrated stimulation scheme or the multi-zone balanced stimulation scheme intended to be implemented. In some embodiments, according to the results of the simulation or modeling, it can be verified whether the designed light treatment device can meet the required synergistic irradiation condition under the intended implementation scheme. The configuration of the light treatment device, especially the spatial arrangement of the lamp panels, can be adjusted accordingly. After the verification is completed, a prototype of the designed light treatment device can be manufactured, and the prototype can be used to irradiate the physical reference headform for testing and verification. It can be understood that if the actual test results on the physical reference headform are good, and given that the size of the reference headform has good representativeness in the sizes of the individual heads of the population of the treated people, the results will have high consistency in subsequent light treatment tests on the population of the treated people. Such a manufacturing process can take into account both the manufacturing cost and the treatment effect.

[0096] Specifically, in some embodiments, the synergistic irradiation condition of the irradiation surface area ratio and the irradiation power level can be defined as follows. In the case of the irradiation surface area ratio of the emitted near-infrared light to the object head being 30% to 40%, the spatiotemporal average light power density irradiated to the object head is 117 mW / cm 2 and 230 mW / cm 2 Below. For example, in this irradiation surface area ratio, the value (unit: mW / cm 2 ) of the spatiotemporal average light power density irradiated to the object head can be any one of all the numerical points in the numerical range of 117 to 230, starting from 117 and distributed at intervals of 0.5-1.

[0097] In the case of the irradiation surface area ratio being between 40% and 65%, the spatiotemporal average light power density irradiated to the object head is 110 mW / cm2or more and 230 mW / cm 2 Below. For example, in this irradiation surface area ratio, the value (unit: mW / cm 2 ) of the spatiotemporal average light power density irradiated to the object head can be any one of all the numerical points in the numerical range of 110 to 230, starting from 110 and distributed at intervals of 0.5-1.

[0098] In the case of the irradiation surface area ratio being 65% or more, the average synergistic dose irradiated to the object head is 2750 W*% to 14100 W*%, the average synergistic dose being the product of the irradiation surface area ratio and the average total power, and the spatiotemporal average light power density irradiated to the object head is 230 mW / cm 2 Below. For example, in this irradiation surface area ratio, the value (unit: W*%) of the average synergistic dose irradiated to the object head can be any one of all the numerical points in the numerical range of 2750 to 14100, starting from 2750 and distributed at intervals of 10.

[0099] However, in the actual manufacturing and verification process, it is not necessary to exhaust each of the above irradiation surface area ratios, but a part of them can be selected, and whether the light treatment device meets the corresponding synergistic irradiation condition can be simulated, simulated, or tested.

[0100] By adopting the flexible combination of the above cranial upper portion 401a, cranial top portion 401b, cranial left portion 401c, cranial right portion 401d, and cranial rear portion 401e, a plurality of representative irradiation surface area ratios can be obtained, thereby facilitating the simulation and verification of the local concentrated stimulation scheme or the multi-zone balanced stimulation scheme accordingly.

[0101] As an example, as shown in FIGS. 4(a)-4(e), the first region 402a, the second region 402b, the third region 402c, the fourth region 402d, and the fifth region 402e are taken as the cranial anterior superior portion 401a, the cranial top portion 401b, the cranial left portion 401c, the cranial right portion 401d, and the cranial posterior portion 401e, respectively, and the ratio of the surface area of each portion to the surface area of the reference head portion is shown in Table 1:

[0102] Table 1 Surface area ratio of cranial anterior superior portion, cranial top portion, cranial left portion, cranial right portion, and cranial posterior portion to reference head portion

[0103]

[0104] That is, the emitted near-infrared light can irradiate any one of the following regions of the subject's head: the cranial anterior superior portion; the cranial anterior superior portion and the cranial top portion, as shown in FIG. 6(a); the cranial anterior superior portion, the cranial left portion, and the cranial right portion, as shown in FIG. 6(b); the cranial anterior superior portion, the cranial left portion, the cranial right portion, and the cranial top portion, as shown in FIG. 6(c); and the cranial anterior superior portion, the cranial left portion, the cranial right portion, the cranial top portion, and the cranial posterior portion, as shown in FIG. 6(d). As an example, when only the cranial anterior superior portion of the subject's head is irradiated, the irradiation surface area ratio is 35.7% (satisfying 30% to 40%), and the spatiotemporal average light power density irradiated to the subject's head is 117 mW / cm 2 or more and 230 mW / cm 2 or less. When only the cranial anterior superior portion and the cranial top portion of the subject's head are irradiated, the irradiation surface area ratio is 59.21% (satisfying between 40% and 65%), or when only the cranial anterior superior portion, the cranial left portion, and the cranial right portion of the subject's head are irradiated, the irradiation surface area ratio is 64.03% (satisfying between 40% and 65%), and the spatiotemporal average light power density irradiated to the subject's head is 110 mW / cm 2 or more and 230 mW / cm 2The irradiation surface area ratio is 87.54% and the average synergistic dose is 2750 W*% to 10800 W*% of the reference head surface area when irradiating the cranial anterior superior part, the cranial left lateral part, the cranial right lateral part and the cranial top part of the subject's head. The irradiation surface area ratio is 100% and the average synergistic dose is 2750 W*% of the reference head surface area to 14100 W*% of the reference head surface area when irradiating the cranial anterior superior part, the cranial left lateral part, the cranial right lateral part, the cranial top part and the cranial posterior part of the subject's head. That is, after the reference head phantom of the subject's head is manufactured, if each part is divided in the above manner, as long as the target irradiation is performed according to the corresponding combination of each part above, the irradiation surface area ratio of 30% to 100% can be conveniently applied, such as the irradiation surface area ratio of 35.7%, 59.21%, 64.03%, 87.54% or 100%. In some embodiments, any irradiation surface area ratio in the range of 30% to 100% can also be flexibly realized by irradiating only part of each part or several part combinations, such as any one of the percentage values starting from 30% and distributed at intervals of 5%.

[0105] Correspondingly, the light treatment device can be adjusted, and the irradiation parameters under the corresponding combination are detected to check whether the spatiotemporal average light power density or the average synergistic dose meets the intended synergistic irradiation condition. If it does, the calibration of the irradiation parameters of the light treatment device under this combination is completed. Further, after leaving the factory, if the user adopts a self-defined combination of each part, the corresponding calibration can also be performed as above to ensure that the self-defined combination of each part meets the required synergistic irradiation condition and ensures the treatment effect on AD.

[0106] In some embodiments, the spatiotemporal average light power density corresponding to the first proportion of the reference scalp surface area of the subject's head irradiated by the emitted near-infrared light is greater than the spatiotemporal average light power density corresponding to the second proportion of the reference scalp surface area of the subject's head irradiated by the emitted near-infrared light, where the first proportion is less than the second proportion. The first proportion and the second proportion can be selected from any one of the following. For example, the first proportion and the second proportion can both be 30% to 40%. For example, the first proportion can be 30% to 40% and the second proportion can be between 40% and 65%. For example, the first proportion and the second proportion can both be between 40% and 65%. For example, the first proportion can be between 40% and 65% and the second proportion can be above 65%. For example, the first proportion and the second proportion can both be above 65%. In some embodiments, the expected spatiotemporal average light power densities corresponding to various proportions of the irradiated surface area can be analyzed by simulation modeling of the light irradiation process of the light treatment device relative to the subject's head. Specifically, the energy attenuation of the near-infrared light of the corresponding wavelength in the scalp, the skull, the cerebrospinal fluid, the dura mater, the arachnoid membrane, and the pia mater, etc. can be taken into account, and the proportion of the surface area and the spatiotemporal average light power density delivered to the target brain region, such as the prefrontal lobe, are targeted, to perform simulation modeling, so as to determine the irradiation area and the spatiotemporal average light power density irradiated to the reference scalp surface of the subject's head. When performing simulation modeling, the proportion of the irradiated surface area can be adjusted by adjusting the irradiation area irradiated to the reference scalp surface of the subject's head, and the spatiotemporal average light power density irradiated to the reference scalp surface of the subject's head can be adjusted accordingly according to the spatiotemporal average light power density relationship of the above first proportion and second proportion, so as to obtain a specific cooperative irradiation scheme for the reference scalp surface of the subject's head. Subsequently, the light treatment device can be calibrated, inspected, and actually operated according to the specific cooperative irradiation scheme.

[0107] As described above, the inventors have creatively found that the time-averaged irradiance level and the proportion of the irradiated surface area delivered to the brain tissue are important factors for the process efficacy of the light therapy in treating AD, and accordingly, the cooperative irradiation conditions required for the near-infrared light irradiation to the subject's head can be characterized in various ways for the important factor of the time-averaged irradiance level. For example, the time-averaged irradiance level can be characterized as the spatiotemporal average light power density, or the total power, or a composite parameter (such as a product, an integral, etc.) after operation with the irradiated surface area. In some embodiments, the average irradiation total power of the emitted near-infrared light irradiated to the subject's head is 23-140 W, or 29-120 W, or 31-100 W. In some embodiments, the corresponding average irradiation total power can also be adapted according to the course of AD.

[0108] For AD patients whose target regions are not clear or are discrete, a multi-region balanced stimulation scheme is preferred. For example, the cranial anterior superior part, the cranial left part, the cranial right part and the cranial top part can be irradiated, or the cranial anterior superior part, the cranial left part, the cranial right part, the cranial top part and the cranial posterior part can be irradiated. The division of each part can refer to the description in other embodiments, but is not limited thereto. Among them, the spatiotemporal average light power density irradiated to the cranial anterior superior part is 50-120 mW / cm 2 , the spatiotemporal average light power density irradiated to the cranial top part is 60-120 mW / cm 2 , the spatiotemporal average light power density irradiated to the cranial left part and the cranial right part is 32-85 mW / cm 2 . In some embodiments, the spatiotemporal average light power density irradiated to the cranial anterior superior part, the cranial top part, the cranial left part, or the cranial right part can be any value obtained by spacing from the lower limit of the corresponding range above by 4-10 mW / cm 2 .

[0109] In some embodiments, if the cranial anterior superior part 401a, the cranial left part 401c, the cranial right part 401d, the cranial top part 401b and the cranial posterior part 401e each contain the corresponding electrode positions as shown in FIGS. 4(a)-4(e), the requirement of the spatiotemporal average light power density can be refined to the electrode site cluster, so as to accurately reflect the fluctuation of the time-averaged light power density of the electrode sites, especially at the boundary of each part.

[0110] In some embodiments, in the case of irradiating at least the cranial anterior superior part, the cranial left part, the cranial right part and the cranial top part, the time-averaged light power density irradiated to the electrode positions Fp1, Fpz, Fp2, AF3, AFz, AF4, F5, F3, F1, Fz, F2, F4, F6, FC1, FC2, FC3, FC4, FC5, FC6, C1, C2, C3, Cz, C4, C5, C6, CP1, CP2, CPz, CP3, CP4, P1, P2, Pz is 50-90 mW / cm 2 . The time-averaged light power density irradiated to the electrode positions FCz, P3, P4, TP7, FT7, T7, FT8, T8, POz, P6, TP8, CP6, P5, CP5, F7, F8, AF7, AF8 is 25-65 mW / cm 2 .

[0111] In some embodiments, in the case of irradiating the cranial anterior superior part, the cranial left part, the cranial right part, the cranial top part and the cranial posterior part, the time-averaged light power density irradiated to the electrode positions P8, P08, O1, O2, Oz, P7, P07 is 1 mW / cm 2 to 30 mW / cm 2 , that is, can fluctuate in this range.

[0112] For the multi-zone equalization stimulation scheme, the headgear 100 of the loose headgear design shown in FIG. 1(b) can be used. In some embodiments, there is a preset spacing between adjacent near-infrared irradiation units (such as LED lamp beads), and each near-infrared irradiation unit has a preset emission angle, so that when the object's head is in place in the accommodation space: the reference head cover part of the object's head corresponds to a peripheral irradiation surface on which near-infrared light is emitted everywhere. The following will be described in combination with Figures 7-9 The light therapy device and its headgear 100 are further described, wherein the peripheral irradiation surface is implemented as the irradiation surface of the transparent inner shell 3, and the surface area of the peripheral irradiation surface is 1200-1700 cm 2 .

[0113] In some embodiments, a plurality of lamp panels 5 are arranged on the middle shell 2 through a lamp panel fixing shell 9, and the lamp panel fixing shell 9 is arranged on the side of the middle shell 2 close to the outer shell 1. As Figure 8 shown, in some embodiments, the lamp panel fixing shell 9 is arranged in the lamp panel accommodating cavity 4, the lamp panel fixing shell 9 is arranged on the side of the middle shell 2 close to the outer shell 1, and a plurality of lamp panels 5 are arranged in layers from top to bottom along the lamp panel fixing shell 9, and the spacing between two lamp panels 5 on the upper layer is greater than the spacing between two adjacent lamp panels 5 on the lower layer, so as to ensure effective light therapy effect on different brain regions of the patient. In some embodiments, the density of the lamp panels arranged at the position corresponding to the top of the patient's head is low, and more dense lamp panels can be arranged at other positions of the patient's head except the position corresponding to the top of the patient's head, but this is only an example. Specifically, the inventors have creatively found that, especially in the headgear 100 as Figures 7-9 shown, at least a few centimeters or even close to 10 centimeters of space is reserved on the top of the head when the object's head is in place, so as to reduce the feeling of oppression of the object during light therapy, but the near-infrared light emitted by the plurality of lamp beads can overlap on the surface of the object's head after propagating through the spacing, and the near-infrared light beams emitted by each lamp panel can also overlap on the surface of the object's head after propagating through the spacing, so that the optical power density of the surface can be maintained at, for example, 80-120 mW / cm 2Please note that the multi-layered circumferential ring distribution of the plurality of lamp panels 5 is merely an example of the array of near-infrared irradiation units. The array of near-infrared irradiation units can also employ LEDs, laser diodes, or optical fibers that transmit near-infrared light from the outside, etc., which are not described herein. In some embodiments, the array of near-infrared irradiation units can be specifically configured to emit near-infrared light with a duty cycle of 30%-70%, a wavelength of 650-1100 nm, and a frequency falling within the frequency range of Alpha waves, the frequency range of Gamma waves, or the neighborhood of both. Among them, the individual near-infrared irradiation device used to constitute the near-infrared irradiation unit can be an LED, and the average optical power thereof can be 90 mW or more.

[0114] In other embodiments of the present application, the plurality of lamp panels 5 can be directly arranged on the middle shell 2.

[0115] In some embodiments, as shown in FIG. 1, six layers of lamp panels 5 are arranged on the lamp panel fixing shell 9 with intervals, and the lamp panels 5 include at least one of the following arrangement modes. Figure 8 Mode one, in the first layer of lamp panels 10 closest to the top of the headgear, there is a first gap between adjacent two lamp panels, and the length of the narrowest position a of the first gap ranges from 23 mm to 26 mm, and the length of the widest position b of the first gap ranges from 57 mm to 60 mm. Further, the length of the narrowest position a of the first gap ranges from 23.5 mm to 25.5 mm, and the length of the widest position b of the first gap ranges from 57.5 mm to 59.5 mm. Preferably, the length of the narrowest position a of the first gap is about 24 mm, and the length of the widest position b of the first gap is about 59 mm. Please note that the phrase “about” in the present application is intended to take measurement errors into account.

[0116] Mode two, in the second layer of lamp panels 11 adjacent to the first layer of lamp panels 10, there is a second gap between adjacent two lamp panels, and the length of the narrowest position of the second gap ranges from 15 mm to 18 mm, and the length of the widest position of the second gap ranges from 41 mm to 44 mm. Further, the length of the narrowest position of the second gap ranges from 16 mm to 17.5 mm, and the length of the widest position of the second gap ranges from 41 mm to 43 mm. Preferably, the length of the narrowest position of the second gap is about 16.7 mm, and the length of the widest position of the first gap is about 42.5 mm.

[0117]

[0118] ​The third gap between the adjacent two lamp panels in the third layer of lamp panels 12 below the second layer of lamp panels 11 has a length ranging from 13mm to 16mm at the narrowest position and a length ranging from 24mm to 27mm at the widest position. Further, the length of the third gap at the narrowest position ranges from 13.5mm to 15.5mm, and the length of the third gap at the widest position ranges from 24mm to 26mm. Preferably, the length of the third gap at the narrowest position is about 14.2mm, and the length of the third gap at the widest position is about 25.3mm.

[0119] The fourth gap between the adjacent two lamp panels in the fourth layer of lamp panels 13 below the third layer of lamp panels 12 has a length ranging from 12mm to 15mm at the narrowest position and a length ranging from 19mm to 22mm at the widest position. Further, the length of the fourth gap at the narrowest position ranges from 13.5mm to 14.5mm, and the length of the fourth gap at the widest position ranges from 19.5mm to 21.5mm. Preferably, the length of the fourth gap at the narrowest position is about 14mm, and the length of the fourth gap at the widest position is about 20.5mm.

[0120] The fifth gap between the adjacent two lamp panels in the fifth layer of lamp panels 14 has a length ranging from 12mm to 15mm at the narrowest position and a length ranging from 16mm to 19mm at the widest position. Further, the length of the fifth gap at the narrowest position ranges from 13mm to 14.5mm, and the length of the fifth gap at the widest position ranges from 16.5mm to 18.5mm. Preferably, the length of the fifth gap at the narrowest position is about 13.8mm, and the length of the fifth gap at the widest position is about 18mm.

[0121] The sixth gap between the adjacent two lamp panels in the sixth layer of lamp panels 15 has a length ranging from 11mm to 14mm at the narrowest position and a length ranging from 15mm to 18mm at the widest position. Further, the length of the sixth gap at the narrowest position ranges from 12mm to 14mm, and the length of the sixth gap at the widest position ranges from 15mm to 17mm. Preferably, the length of the sixth gap at the narrowest position is about 13mm, and the length of the sixth gap at the widest position is about 16.2mm.

[0122] The above structure can achieve dynamic balance of the overall temperature inside the headgear under the premise that the lamp panels 5 emit light to achieve the light therapy effect. The spacing of the lamp panels 5 and the setting between the adjacent layers of lamp panels 5 avoid concentrated heat dissipation of the lamp panels 5, prevent the local temperature inside the headgear from being too high, and save energy consumption.

[0123] In optional embodiments, as shown in Figure 8 the gap between the adjacent two lamp panels 5 in each layer has a narrowest position and a widest position respectively, and the width of the gap between the adjacent two lamp panels 5 on the upper layer is greater than the width of the gap between the adjacent two lamp panels 5 on the lower layer. In this way, the local temperature in the light therapy head cap caused by the dense arrangement of the lamp panels 5 is significantly reduced while ensuring the irradiation of the lamp panels 5 to achieve the light therapy effect. Since the structure design of the light therapy device head cap makes the accommodation space form a trend of gradually increasing inner diameter from top to bottom, the arrangement spacing of the first layer of lamp panels 10 and the second layer of lamp panels 11 is enlarged, which, under the premise of ensuring the uniformity of the light power density, also avoids the accumulation of heat emitted by the lamp panels 5 in the head cap, facilitating cooling. In order to achieve the uniformity of the light power density in the entire accommodation space, the optimal average light power of the first layer of lamp panels 10 and the second layer of lamp panels 11 can be 75-125 mw, and preferably 90-100 mw.

[0124] As shown in Figure 8 in some embodiments, the vertical spacing between the first layer of lamp panels 10 and the second layer of lamp panels 11 is 19-25 mm, and preferably 19.5-24.5 mm. The vertical spacing between the second layer of lamp panels 11 and the third layer of lamp panels 12 is 14-21 mm, and preferably 15-20 mm.

[0125] As shown in Figure 8 in some embodiments, the vertical spacing between the remaining adjacent two layers of lamp panels is 13-19 mm, and preferably 14-18 mm. The vertical spacing between the adjacent two layers of lamp panels can not only meet the irradiation to the entire brain region, but also avoid the accumulation of heat emitted by the lamp panels 5 in the accommodation space.

[0126] Therefore, the arrangement of the lamp panels 5 can irradiate the entire region of the patient's head, including the temporal lobe, occipital lobe, frontal lobe, and parietal lobe, without affecting the normal progress of light therapy, and also improves the comfort of the treatment process.

[0127] In addition, as shown in Figure 9 the lamp panels 5 are connected with the lamp panel fixing frame 17, and the lamp panels 5 are fixed to the lamp panel fixing shell 9 through the lamp panel fixing frame 17. In some embodiments, the spacing between the adjacent lamp panel fixing frames 17 in each layer of lamp panel fixing frames 17 is similar to or the same as the spacing between the corresponding adjacent lamp panels 5.

[0128] Returning to Figure 7In combination with FIG. 1(b), in some embodiments, the headgear is provided with a ring-shaped connecting portion 18, and the bottom of the outer shell 1 and the middle shell 2 are connected to the connecting portion 18, respectively. The connecting portion 18 is provided with a plurality of air vents 16 communicating with the lamp plate accommodating cavity 4, and the area of each air vent 16 at the rear end of the headgear is greater than the area of each air vent 16 at the front end of the headgear. Further, the air vents 16 can be in the shape of a long strip. In this way, the air flow entering the rear end of the headgear can be increased, so as to improve the cooling effect of the lamp plate accommodating cavity 4 and balance the cooling effect at the occiput and the forehead of the headgear. It also reduces the heat transfer from the lamp plate accommodating cavity 4 to the cold air cavity 6, thereby facilitating the improvement of the cooling effect on the accommodating space.

[0129] In some embodiments, the top of the headgear is provided with an air extraction port communicating with the lamp plate accommodating cavity 4, for extracting hot air in the lamp plate accommodating cavity 4.

[0130] In some embodiments, 80 lamp plates 5 are distributed in the headgear, and the size of the near-infrared light exit port of each lamp plate 5 is 28mm x 28mm, with a tolerance of ±0.2mm, and the lamp beads are arranged in a 3x3 array.

[0131] We have carried out a series of clinical experiments using the light treatment device of this structure. As an example, the array of near-infrared irradiation units emits near-infrared light with a central wavelength of 810nm, a duty cycle of 50%, and a frequency of 10Hz, but it should be noted that this is only an example.

[0132] In some embodiments, the near-infrared light can be emitted with a duty cycle of 30%-70%, a wavelength of 650-1100nm, and a frequency falling within the frequency range of Alpha waves, the frequency range of Gamma waves, or the neighborhood of both, which will not be described here.

[0133] In some embodiments, the array of near-infrared irradiation units is specifically configured to irradiate at least 8260-42250 joules of energy to the head of the subject as a unit dose within a continuous irradiation time of 5 minutes. The irradiation of 8260 joules of energy within 5 minutes is equivalent to continuous irradiation of the calvaria with a time-averaged irradiation power of 27.5W, and the surface area of the calvaria is 612.35cm 2 , the space-time average light power density is 45mW / cm 2 ; and the irradiation of 42250 joules of energy within 5 minutes is equivalent to continuous irradiation of the calvaria with a time-averaged irradiation power of 140W, and the surface area of the calvaria is 612.35cm 2 , the space-time average light power density is 230mW / cm 2The inventors found in clinical experiments that for some AD patients in moderate and severe dementia stage, it is difficult to sustain for 10 minutes to half an hour without interruption, some AD patients are severely cognitively impaired and do not cooperate, and some AD patients also frequently have abnormal limb movements, such as muscle stiffness and flexion, muscle atrophy and weakness, apraxia, etc. Taking 5 minutes as a unit dose means that each 5 minutes of irradiation has an inhibitory effect on AD to some extent.

[0134] For example, the energy dose required to irradiate the subject's head in a single time period of 1 hour, such as 3 unit doses, at least 24800 joules-126800 joules of energy, can be performed in separate or continuous effective unit doses, so that the single time period cumulative dose delivered can achieve a comparable AD inhibitory effect as the single time period cumulative dose delivered in a continuous 15-minute uninterrupted delivery. In actual treatment, even if the AD patient is interrupted due to his own reasons or operation failure, the operator only needs to ensure that the cumulative irradiation time in a single time period meets the requirements, without the need to restart the light treatment equipment, without the need to clear the irradiation dose of the current time, and without the need to interrupt the irradiation hard. Specifically, if the subject has high cooperation and the treatment is also very smooth, he can be directly continuously irradiated for 15 minutes. If the subject has low cooperation or the treatment is not smooth, and he needs to go to the bathroom for 6 minutes, the treatment can be temporarily interrupted, and he can continue to be irradiated after he returns. The interruption time can be flexibly adjusted according to the needs of the subject, as long as the irradiation duration is achieved within 1 hour. This significantly reduces the operation difficulty of light treatment for AD patients with severe cognitive impairment or severe motor abnormalities that do not cooperate, as well as for subject groups with varying severity of AD symptoms (such as cross-age nursing home populations), and even for nursing staff with insufficient experience in caring for AD patients.

[0135] In some embodiments, the array of near-infrared irradiation units is specifically configured to irradiate at least 24800 Joules - 7100000 Joules of energy to the subject's head in a single day as a single-day cumulative dose. It can be seen that the single-day cumulative dose can have a span of nearly 40 times, with a lower limit of 15 minutes of cumulative irradiation at a time-averaged irradiation power of 27.5 W, and an upper limit of 2 hours of irradiation at a time-averaged irradiation power of 140 W. The inventors have found that with the light treatment device of the present application, the single-day cumulative dose can be adjusted at a large span according to the subject's adaptability. Specifically, if the subject has a high degree of cooperation for the light treatment and an individual response is good, the array of near-infrared irradiation units is specifically configured to provide an accelerated single-day cumulative dose by implementing a single-period cumulative dose by continuously irradiating for more than 30 minutes in a single period of 1 hour, and the single-period cumulative dose can be implemented up to 4 times in a single day. The accelerated single-day cumulative dose is equivalent to the amount of several days of the lower limit of the single-day cumulative dose. In the case where the subject needs to interrupt the treatment for several days due to specific circumstances, the accelerated single-day cumulative dose can be performed first, thereby increasing the flexibility and convenience of the light treatment. In addition, although the mechanism of action is not clear, the progress of cognitive performance of the individual volunteer after the implementation of the accelerated single-day cumulative dose is even better than the effect of the same cumulative dose implemented for several days. In some embodiments, the weekly cumulative dose irradiated to the subject's head can be as low as 24800 Joules, and the irradiation time can be as short as 15 minutes.

[0136] In some embodiments, the array of near-infrared irradiation units is specifically configured to irradiate at least 24800 Joules - 7100000 Joules of energy to the subject's head in a single day as a single-day cumulative dose. It can be seen that the single-day cumulative dose can have a span of nearly 40 times, with a lower limit of 15 minutes of cumulative irradiation at a time-averaged irradiation power of 27.5 W, and an upper limit of 2 hours of irradiation at a time-averaged irradiation power of 140 W. The inventors have found that with the light treatment device of the present application, the single-day cumulative dose can be adjusted at a large span according to the subject's adaptability. Specifically, if the subject has a high degree of cooperation for the light treatment and an individual response is good, the array of near-infrared irradiation units is specifically configured to provide an accelerated single-day cumulative dose by implementing a single-period cumulative dose by continuously irradiating for more than 30 minutes in a single period of 1 hour, and the single-period cumulative dose can be implemented up to 4 times in a single day. The accelerated single-day cumulative dose is equivalent to the amount of several days of the lower limit of the single-day cumulative dose. In the case where the subject needs to interrupt the treatment for several days due to specific circumstances, the accelerated single-day cumulative dose can be performed first, thereby increasing the flexibility and convenience of the light treatment. In addition, although the mechanism of action is not clear, the progress of cognitive performance of the individual volunteer after the implementation of the accelerated single-day cumulative dose is even better than the effect of the same cumulative dose implemented for several days. In some embodiments, the weekly cumulative dose irradiated to the subject's head can be as low as 24800 Joules, and the irradiation time can be as short as 15 minutes. 2 - every day for 2 hours - 7 days) as a weekly cumulative dose. Specifically, the single-period cumulative dose can be implemented for 1 time, 2 times, 3 times, 4 times, 5 times, 6 times, 7 times, or 8 times in each day of the week in which irradiation is implemented.

[0137] Specifically, the array of near-infrared irradiation units is specifically configured to implement more than 8 times of the weekly cumulative dose in 8 weeks, and preferably more than 16 times of the weekly cumulative dose in 16 weeks, as a course cumulative dose.

[0138] In some embodiments, the course interruption time between two courses does not exceed half of the course duration, in order to avoid the deterioration of the AD pathological condition caused by the interruption of the treatment as much as possible.

[0139] The applicant conducted a clinical experiment on the test group (i.e., the treatment group) using the light treatment device shown in FIGS. 1(a) and 1(b), the spatiotemporal average light power density of the light treatment device at each part of the reference head model on the subject's head, and the time average light power density of the irradiation surface of the inner shell 3 corresponding to the center position of the lamp panel, as shown in Table 2.

[0140] Table 2 Spatiotemporal average light power density of the light treatment device at each part of the reference head model

[0141]

[0142] The applicant conducted a clinical experiment on the test group (i.e., the treatment group) using the light treatment device with the operating parameters in Table 3.

[0143] Table 3 Operating parameters of the light treatment device

[0144]

[0145] The light treatment device in this clinical experiment, when in place in the accommodating space formed by the bearing mechanism on the subject's head, emitted near-infrared light that could cover the front upper part of the skull, the top of the skull, the left side of the skull, the right side of the skull, and the back of the skull of the subject's head, with an irradiation surface area ratio of greater than 65%, meeting the synergistic irradiation conditions of the irradiation surface area ratio and the irradiation power level, as shown in Tables 2 and 3, with an average synergistic dose of about 3200 W*% to 4800 W*% irradiated to the subject's head, and a spatiotemporal average light power density of 230 mw / cm 2 The following.

[0146] The inclusion criteria for this clinical experiment were as follows: (1) meeting the core criteria for possible Alzheimer's disease (AD) defined by the National Institute on Aging-Alzheimer's Association (NIA-AA); (2) results of cranial MRI examination (within 6 months) supporting possible AD diagnosis; (3) age between 50 and 85 years old, regardless of gender; (4) MMSE score < 26 points, able to cooperate with scale assessment; (5) patient not in medication period, if taking mental or cognitive improvement drugs, must have stable dose at least 12 weeks before the experiment, and remain unchanged during the treatment period.

[0147] Exclusion criteria: (1) presence of MRI contraindications, such as metal implants or claustrophobia, etc.; (2) other types of dementia or other mental or nervous system diseases, such as depression or Parkinson's disease; (3) history of stroke or epilepsy; (4) photosensitivity to sunlight or visible light, or increased skin sensitivity in the treatment area; (5) severe visual or hearing impairment; (6) history of alcohol or drug addiction; (7) any other condition not suitable for participating in this study.

[0148] According to the inclusion and exclusion criteria, a total of 27 patients were enrolled, 13 in the experimental group and 14 in the control group. The treatment group received whole-head near-infrared light stimulation: wavelength 810 nm, frequency 10 Hz, each participant received 30 minutes of treatment once a day, 6 days a week, for 4 months. The placebo treatment group (control group) had exactly the same program as the near-infrared light treatment group, but used a placebo treatment head cap. The light emitted by the placebo treatment device is visually identical to the near-infrared treatment device, and produces similar sounds and a warm feeling on the scalp during treatment, but the light power is very weak and is basically absorbed by the tissue, and cannot achieve the effect of stimulating brain tissue, see Figure 10 .

[0149] Scale assessments were conducted at the 2nd and 4th months during treatment, and at 2 and 4 months after treatment ended (6th and 8th months), as Figure 10 indicated. The assessors, subjects, and their caregivers were unaware of the treatment allocation throughout the study until the end of the study. And throughout the study, the relevant personnel did not discuss the treatment allocation. The subjects all believed that they were receiving real near-infrared treatment.

[0150] Finally, a total of 18 patients (9 in the treatment group and 9 in the control group) completed 4 months of treatment and 4 months of evaluation, of which 1 patient only completed the MMSE scale evaluation in the scale evaluation, and did not complete the ADAS-cog scale. The ADAS-Cog scale consists of 12 items covering memory, orientation, language, application, attention, etc., and can assess the severity of AD cognitive symptoms and treatment changes, and is commonly used for efficacy evaluation of mild to moderate AD (usually 4 points of improvement is considered as a clinically significant drug effect). The MMSE scale is the most widely used cognitive screening scale at home and abroad, covering orientation, memory, attention, calculation, language ability, and visual spatial ability. Studies on MMSE have found that in professional institutions such as memory clinics or in community hospitals, the sensitivity and specificity of MMSE in distinguishing normal elderly and dementia both reach more than 80%, and it has good value for screening dementia.

[0151] In order to explore the persistence of the effect of near-infrared light on AD patients, follow-up visits were conducted on the subjects after treatment ended. A total of 14 subjects completed the 8th month follow-up (4 months after treatment ended, 8 in the treatment group and 6 in the control group).

[0152] Referring to FIG. 11(a) and FIG. 11(b), it can be seen that the ADAS-cog scale score of the subjects in the treatment group after 2 months of light treatment is reduced by an average of 1.11 points from the baseline, and continues to decrease with a greater slope after 4 months of treatment, and is reduced by an average of 6.04 points from the baseline, and the statistical significance within the group is p = 0.034 < 0.05, which is significantly better than the score of the control group. Within 2 months after the end of the treatment, the ADAS-cog scale score of the treatment group fluctuates less, and still remains reduced by an average of 5.59 points from the baseline 2 months after the end of the treatment, and the statistical significance within the group is p = 0.009 < 0.05. After the follow-up 2 months after the end of the treatment, the ADAS-cog scale score of the treatment group even starts to continue to decrease, and is reduced by an average of 8.25 points from the baseline 4 months after the end of the treatment, and the statistical significance within the group is p = 0.008 < 0.05. From the ADAS-cog scale score, the light treatment device of the present application achieves a beneficial effect that has never appeared in the papers and related literature of other light therapy devices: within 4 months of light therapy, the ADAS-cog scale score decreases with a greater slope after the second month than in the first two months; every two months after the end of the light therapy, it is found that the biochemical reaction caused by the irradiation energy of the near-infrared light delivered to the head of the object continues to trigger the inhibitory effect after the end of the light therapy, not only maintains the inhibitory effect on AD to a certain extent, but also continuously promotes the inhibitory effect on AD, and there is no degradation of the ADAS-cog scale score.

[0153] As shown in FIG. 12(a) and FIG. 12(b), the MMSE scale score of the subjects in the treatment group was improved by 0.67 on average after 2 months of light treatment, and the MMSE scale score was continuously improved with a greater slope in the following 2 months of light treatment, and was improved by 2.78 on average from the baseline after 4 months of light treatment, which was significantly better than the score of the control group, and the statistical significance within the group was P = 0.025 < 0.05. From the ADAS-cog scale score and the MMSE scale score in the first 2 months and the last 2 months of light treatment, similar improvement effects were shown: the last 2 months were continuously improved with a greater slope. Further, similar to the continuous improvement of the ADAS-cog scale score after the end of light treatment, the MMSE scale score was still continuously rising in the 2 months after the end of light treatment, even with a rising slope comparable to that during light treatment, and was improved by 3.89 on average from the baseline, and the statistical significance within the group was p = 0.004 < 0.05. After 4 months of the end of light treatment, the MMSE scale score of the treatment group was still comparable to the MMSE scale score obtained after 4 months of light treatment, and no degradation was observed. That is, from the MMSE scale score, the biochemical reaction caused by the irradiation energy of the near-infrared light delivered to the head of the subject was still continuously triggering the inhibitory effect after the end of light treatment, not only maintaining the inhibitory effect on AD to some extent, but also continuously promoting the inhibitory effect on AD, and no degradation of the ADAS-cog scale score was observed.

[0154] In combination with the results of the ADAS-Cog scale score and the MMSE scale score during and after the follow-up after the end of light treatment, it is also confirmed that the optimization of the light treatment device of the present application mentioned in the foregoing and the continuous benefit process: the "light charging capacity" of the brain of the subject is larger, the "light charging depth" is deeper, and the "light charging speed" is faster, the scale score improvement in the first 2 months and the last 2 months of light treatment is very significant, and occurs with a stable slope without stagnation; the subsequent "endurance" ability and continuous benefit are better, the effect of 2 months of light treatment is maintained at least to 2 months after the end of light treatment, and even to 4 months after the end of light treatment, and the biochemical reaction caused by "light charging" is still continuously triggering the inhibitory effect after the end of light treatment, and continuously promoting the inhibitory effect on AD, and no degradation is observed.

[0155] Further, after 4 months of near-infrared light treatment, the resting-state functional magnetic resonance examination results of the subjects in the treatment group showed that the ALFF of multiple brain regions of the frontal lobe, occipital lobe and temporal lobe was enhanced (P < 0.05), indicating that the neuronal excitability and spontaneous activity of the subjects were enhanced, which provided neuroimaging evidence for the improvement of the corresponding cognitive function. At the same time, no adverse events related to the test instrument were observed in the present test.

[0156] Although the light therapy in this clinical trial lasted for 4 months, the light therapy showed the characteristics of deep regulation and sustained and even accumulated benefits, and the benefits would continue to increase if the light therapy was used for a longer time, such as 6 months, 8 months, 10 months, … 1 year or more, or even used all year round, which would reflect a more significant disease-modifying effect.

[0157] Furthermore, although exemplary embodiments have been described herein, the scope of their protection is limited by the appended claims, which are to be accorded the full scope of equivalents thereof. The claims are to be interpreted broadly, in a manner similar to the way the elements of a claim are interpreted under 35 U.S.C. § 112, 6th paragraph, and likewise to the manner a claim is interpreted under 35 U.S.C. § 101. In this regard the criteria set forth in the Manual of Patent Examining Procedures, Section 2111.03, are specifically incorporated herein by reference in their entirety. Under those criteria, the claim is to be given its broadest reasonable interpretation, which includes not only the specific embodiments disclosed in the specification but also "any and all changes or modifications within the scope of the disclosure."

[0158] The above description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more aspects thereof) can be used in combination with each other. Other embodiments can be used as well, which will become apparent to those of ordinary skill in the art upon reading the above description. Further, in the detailed description, various features can be grouped together to streamline the disclosure. This should not be interpreted as a requirement that the features must be provided together, merely because they are grouped together. Rather, the subject disclosure will cover any patentable aspects of a claim that can come in any number of different claim sets, and the subject disclosure can be amended to add claims that depend on or otherwise are related to a claim or claims. As the subject disclosure is intended to cover all aspects of the claim sets, the claims should not be construed as limiting of the subject disclosure in any way. The scope of the subject disclosure should be determined with reference to the claims and the full scope of equivalents to which they are entitled.

[0159] The above embodiments are only exemplary embodiments of the present disclosure, and are not intended to limit the present disclosure. The protection scope of the present disclosure is defined by the claims. Those skilled in the art can make various modifications or equivalent replacements to the present disclosure within the spirit and protection scope of the present disclosure, and such modifications or equivalent replacements should also be considered to fall within the protection scope of the present disclosure.

Claims

1. A light treatment device for the treatment of Alzheimer's disease and its associated conditions, characterized in that, The application comprises: a bearing mechanism configured to form a containing space for a subject's head, and to bear an array of near-infrared irradiation units; and the array of near-infrared irradiation units configured to emit near-infrared light into the containing space, wherein, in the case that the subject's head is in place in the containing space, the irradiation surface area ratio of the irradiation of the emitted near-infrared light to the subject's head to a reference head cover surface area in the range of 30% to 40%, or between 40% and 65%, or above 65%, and the irradiation power level of the emitted near-infrared light is set in coordination with the irradiation surface area ratio in the range, so that the irradiation to the subject's head satisfies the coordination irradiation condition of the irradiation surface area ratio and the irradiation power level, and the reference head cover surface area is the outer surface area of the surface of the subject's head within a total boundary line, the total boundary line passing through the glabella point of the subject's head, along the brow bone, through the preauricular points on both sides, and converging backward through the inion and the electrode positions O1, OZ and O2 of the 10-10 international standard electrode system. The coordination irradiation condition of the irradiation surface area ratio and the irradiation power level comprises at least one of the following: The coordination irradiation condition of the irradiation surface area ratio and the irradiation power level characterizes at least one of the following: In the case where the irradiated surface area ratio of the emitted near-infrared light to the head of the subject is 30% to 40%, the spatiotemporal average light power density irradiated to the head of the subject is 117 mW / cm 2 The above and 230 mW / cm 2 The following; The spatiotemporal average optical power density irradiated to the subject's head is 110 mW / cm 2 above and 230 mW / cm 2 below; In the case where the irradiation surface area ratio is 65% or more, the average synergistic dose to the subject's head is 2750 W up to 14100 W The average synergistic dose is the product of the percentage of the irradiation surface area ratio and the average total power, and the spatiotemporal average optical power density to the subject's head is 230 mW / cm 2 The following.

2. The light therapy device of claim 1, wherein, The correlation between the irradiation surface area ratio and the spatio-temporal average light power density; The product of the average total power of the irradiation to the subject's head and the percentage of the total irradiation surface area ratio; or The integral of the power of the irradiation to each sub-zone of the subject's head with respect to the irradiation surface area ratio of each sub-zone. The coordination irradiation condition of the irradiation surface area ratio and the irradiation power level specifically comprises any one of the following:

3. Light therapy device according to claim 1 or 2, characterized in that, The average light power density corresponding to the first proportion of the reference head cover surface area of the subject's head irradiated by the emitted near-infrared light is greater than the average light power density corresponding to the second proportion of the reference head cover surface of the subject's head irradiated by the emitted near-infrared light, wherein the first proportion is less than the second proportion. The spatiotemporal average optical power density to the subject's head was 117 mW / cm 2 above and 230 mW / cm 2 below. When irradiating only the cranial anterior upper portion and the cranial top portion of the subject's head, or irradiating only the cranial anterior upper portion, the cranial left side portion, and the cranial right side portion of the subject's head, the spatiotemporal average light power density irradiated to the subject's head is 110 mW / cm 2 The above and 230 mW / cm 2 The following; The average synergistic dose was 2750 W to 10800 W when irradiating the anterio-superior, left-lateral, right-lateral and parietal parts of the head of the subject ;​ The average synergistic dose was 2750 W when irradiating the anterio-superior, left-lateral, right-lateral, parietal and posterior parts of the head of the subject up to 14100 W .

4. The light therapy device of claim 1, wherein, The first proportion and the second proportion are selected from any one of the following:

5. The light therapy device of claim 4, wherein, Both the first proportion and the second proportion are 30% to 40%; The first proportion is 30% to 40%, and the second proportion is between 40% and 65%; Both the first proportion and the second proportion are between 40% and 65%; The first proportion is between 40% and 65%, and the second proportion is above 65%; Both the first proportion and the second proportion are above 65%. The average irradiation total power of the emitted near-infrared light to the subject's head is 23-140W, or 29-120W, or 31-100W.

6. Light therapy device according to any of claims 1, 2, 4 and 5, characterized in that, The subject's head comprises the head of a subject, or a reference head model of a subject population, wherein the emitted near-infrared light irradiates any one of the following regions of the subject's head: the cranial anterior superior part; the cranial anterior superior part and the cranial top part; the cranial anterior superior part, the cranial left side part and the cranial right side part; the cranial anterior superior part, the cranial left side part, the cranial right side part and the cranial top part; the cranial anterior superior part, the cranial left side part, the cranial right side part, the cranial top part and the cranial posterior part, 7. Light therapy device according to any of claims 1, 2, 4 and 5, characterized in that, The parameters of the reference head model of the subject population are any one of the following: ​ The head width is 140-166 mm, the head length is 170-196 mm, the head circumference is 525-583 mm, the morphological facial length is 104-130 mm, the head sagittal arc is 304-372 mm, the inter-antitragus arc is 320-375 mm, and the head height is 206-253 mm; or The head width is 152 mm, the head length is 184 mm, the head circumference is 536.7 mm, the morphological facial length is 109.3 mm, the head sagittal arc is 355.6 mm, the inter-antitragus arc is 324.1 mm, and the head height is 206 mm.

8. The light therapy device of claim 7, wherein, According to the 10-10 standard lead system, The cranial anterior superior part forms a region including electrode positions FP2, FPZ, FP1, AF3, AF4, AF7, AF8, AFZ, FZ, F1, F2, F3, F4, F5, F6, F7, F8, FC1, FC2, FC3, FC4, FCZ, The cranial top part forms a region including electrode positions CZ, C1, C2, C3, C4, CPZ, CP1, CP2, CP3, CP4, PZ, P1, P2, P3, P4, The cranial left side part forms a region including electrode positions FT7, FC5, T7, C5, TP7, CP5, P7, P5, and the cranial right side part forms a region including electrode positions FT8, FC6, T8, C6, TP8, CP6, P8, P6, The cranial posterior part forms a region including electrode positions PO7, PO5, PO3, POZ, PO4, P06, PO8, O1, OZ, and O2.

9. The light therapy device of claim 7, wherein, The cranial anterior superior part is in a first region surrounded by a first boundary line and the total boundary line, according to the 10-10 standard lead system, the first boundary line sequentially passes between the following electrode positions: between F7 and FT7, between F5 and FC5, between FC3 and C3, between FC1 and C1, between FCZ and CZ, between FC2 and C2, between FC4 and C4, between F6 and FC6, and between F8 and FT8; The cranial top part is in a second region surrounded by a second boundary line, according to the 10-10 standard lead system, the second boundary line sequentially passes between the following electrode positions: between FC3 and C3, between FC1 and C1, between FCZ and CZ, between FC2 and C2, between FC4 and C4, between C6 and C4, between CP6 and CP4, between P6 and P4, between PO4 and P4, between PO4 and P2, between POZ and P2, between POZ and PZ, between POZ and P1, between PO3 and P1, between PO3 and P3, between P5 and P3, between CP5 and CP3, and between C5 and C3; The cranial left side portion is in a third region surrounded by a third boundary line and the total boundary line, and the third boundary line sequentially passes between the following electrode positions according to the 10-10 standard electrode system: between FT7 and F7, between FC5 and F5, between FC5 and FC3, between C5 and C3, between CP5 and CP3, between P5 and P3, between P5 and PO5, and between P7 and PO7; The cranial right side portion is in a fourth region surrounded by a fourth boundary line and the total boundary line, and the fourth boundary line sequentially passes between the following electrode positions according to the 10-10 standard electrode system: between FT8 and F8, between FC6 and F6, between FC6 and FC4, between C6 and C4, between CP6 and CP4, between P6 and P4, between P6 and PO6, and between P8 and PO8; The cranial posterior portion is in a fifth region surrounded by a fifth boundary line and the total boundary line, and the fifth boundary line sequentially passes between the following electrode positions according to the 10-10 standard electrode system: between P7 and PO7, between P5 and PO5, between P3 and PO3, between P1 and POZ, between PZ and POZ, between P2 and POZ, between P4 and PO4, between P6 and PO6, and between P8 and PO8.

10. The light therapy device of claim 9, wherein, The surface area of the cranial anterior superior portion is more than 70% of the surface area of the first region, the surface area of the cranial parietal portion is more than 70% of the surface area of the second region, the surface area of the cranial left side portion is more than 70% of the surface area of the third region, the surface area of the cranial right side portion is more than 70% of the surface area of the fourth region, and the surface area of the cranial posterior portion is more than 70% of the surface area of the fifth region.

11. The light therapy device of claim 7, wherein, In the case of irradiation to the cranial anterior superior portion, the cranial left side portion, the cranial right side portion, and the cranial parietal portion, or irradiation to the cranial anterior superior portion, the cranial left side portion, the cranial right side portion, the cranial parietal portion, and the cranial posterior portion, spatially and temporally averaged light power density of 50-120 mW / cm 2 spatially and temporally averaged light power density of 60-120 mW / cm 2 spatially and temporally averaged light power density of 32-85 mW / cm 2 to the left side of the head and to the right side of the head.

12. The light therapy device of claim 7, wherein, In the case of irradiation to at least the cranial anterior superior portion, the cranial left side portion, the cranial right side portion, and the cranial parietal portion, The time-averaged optical power density irradiated to the electrode positions Fp1, Fpz, Fp2, AF3, AFz, AF4, F5, F3, F1, Fz, F2, F4, F6, FC1, FC2, FC3, FC4, FC5, FC6, C1, C2, C3, Cz, C4, C5, C6, CP1, CP2, CPz, CP3, CP4, P1, P2, Pz is 50-90 mW / cm2 2 , The time-averaged optical power density irradiated to the electrode positions FCz, TP7, FT7, T7, FT8, T8, POz, P6, TP8, CP6, P5, CP5, F7, F8, AF7, AF8 is 25-65 mW / cm 2 .

13. The light therapy device of claim 12, wherein, In the case of irradiation to the upper portion of the head, the left portion of the head, the right portion of the head, the top of the head, and the back of the head, the time-averaged optical power density at the electrode positions P8, P08, 01, 02, Oz, P7, P07 is 1 mW / cm 2 to 30 mW / cm 2 .

14. Light therapy device according to any of claims 1, 2, 4 and 5, characterized in that, The unit dose of irradiation to the subject's head is at least 8260-42250 joules of energy to the subject's head over a 5 minute duration of irradiation.

15. Light therapy device according to any of claims 1, 2, 4 and 5, characterized in that, The single session cumulative dose of irradiation to the subject's head is at least 24800-126800 joules of energy to the subject's head in a single session of 1 hour in separate or continuous effective unit doses.

16. The light therapy device of claim 15, wherein, The single session cumulative dose can have a cumulative irradiation time of more than 30 minutes in a single session of 1 hour.

17. Light therapy device according to any of claims 1, 2, 4 and 5, characterized in that, The single day cumulative dose of irradiation to the subject's head is at least 24800-1014050 joules of energy to the subject's head in separate single session cumulative doses in a single day.

18. The light therapy device of claim 17, wherein, In the case of the single session cumulative dose having a cumulative irradiation time of more than 30 minutes in a single session of 1 hour, it can be implemented up to 4 times to provide an accelerated single day cumulative dose.

19. Light therapy device according to any of claims 1, 2, 4 and 5, characterized in that, The weekly cumulative dose of irradiation to the subject's head can be as low as 24800 joules, and the irradiation time can be as little as 15 minutes.

20. Light therapy device according to any of claims 1, 2, 4 and 5, characterized in that, The weekly cumulative dose of irradiation to the subject's head is: at least 124,000 Joules to 7,000,000 Joules of energy in separate single time period cumulative doses to the subject's head over a week, the single time period cumulative doses being administered in time periods that are administered 1, 2, 3, 4, 5, 6, 7, or 8 times over the days of the week in which the irradiation is administered.

21. Light therapy device according to any of claims 1, 2, 4 and 5, characterized in that, The light treatment device further comprises a cooling mechanism configured to, in the case that the time-averaged total irradiation power to the subject's head reaches 27.5-120 W and the single continuous irradiation duration reaches 30 minutes, cause the temperature of the air in the space adjacent to but not in contact with the subject's head to not exceed 41℃.

22. Light therapy device according to any of claims 1, 2, 4 and 5, characterized in that, The adjacent near-infrared irradiation units have a preset interval, and each near-infrared irradiation unit has a preset emission angle, so that, in the case that the subject's head is in place in the accommodating space: the near-infrared light is emitted at each position on the peripheral irradiation surface corresponding to the reference head cover portion of the subject's head.

23. The light therapy device of claim 22, wherein, The surface area of the peripheral irradiation surface is 1200-1700 cm 2 .

24. Light therapy device according to any of claims 1, 2, 4 and 5, characterized in that, The array of near-infrared irradiation units is specifically configured to emit near-infrared light with a duty cycle of 30%-70%, a wavelength of 650-1100 nm, and a frequency falling within the frequency range of Alpha waves, the frequency range of Gamma waves, or the neighborhood of both, wherein the time-averaged optical power of a single near-infrared irradiation device used to constitute the near-infrared irradiation unit is 90 mW or more.

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