Phototherapy device for inhibiting or preventing alzheimer's disease

Abstract

Provided in the present application is a phototherapy device for inhibiting or preventing Alzheimer's disease (AD). The phototherapy device comprises a supporting structure and an array of near-infrared irradiation units. A supporting mechanism forms an accommodating space for a subject's head and supports the array of the near-infrared irradiation units. The array of the near-infrared irradiation units is configured to: emit near-infrared light into the accommodating space, and form, when the subject's head is in place, an irradiation spatial range covering at least the anterior superior part, vertex, and left and right lateral parts of the cranium, wherein the time-averaged total irradiation power applied to the cranial region of the subject's head reaches 27.5 W or more, 31 W or more, 40 W or more, 60 W or more, or 70 W or more, and the spatiotemporal-averaged optical power density irradiated to each region does not exceed 230 mW / cm2. The phototherapy device realizes optimized therapeutic effects of an AD patient from MCI to dementia stages during a treatment course, without depending on nasal and ocular irradiation, and can not only effectively maintain but also continuously enhance the therapeutic effects when phototherapy is interrupted.

Description

A light therapy device for inhibiting or preventing Alzheimer's disease Technical Field

[0001] The present application belongs to the technical field of light therapy equipment for brain and cognitive diseases, and in particular, relates to a light therapy equipment for inhibiting or preventing Alzheimer's disease. Background Art

[0002] Alzheimer's disease (AD) is a chronic, progressive neurodegenerative disease that primarily affects older adults, particularly those over 60. The disease is characterized by memory loss, impairment of social and occupational functioning, executive function impairment, speech and motor deficits, personality changes, and behavioral and psychological disturbances.

[0003] According to the international guidelines for clinical staging, the course of AD can be divided into three stages: preclinical stage, mild cognitive impairment (MCI) stage and dementia stage. The dementia stage can be further divided into mild, moderate and severe dementia stages.

[0004] In the early clinical stage, biological samples collected from the individual's brain undergo changes in biomarkers, and these changes can be detected by medical means, such as abnormal changes in amyloid and tau proteins that can be identified by PET or biochemical tests in cerebrospinal fluid / blood, but no symptoms such as memory loss are manifested.

[0005] It is important to note that many years before AD is diagnosed, there may not be any AD symptoms, but AD pathological changes may have already occurred, such as the development of amyloid plaques (Aβ) in the cerebral cortex. This pathological change is currently speculated to require the cooperation of other pathological changes, such as neurofibrillary tangles, that is, tau-PET positivity, to progress to the next pathological stage - MCI. In the MCI stage, changes in AD biomarkers are accompanied by changes in cognitive function, such as a slow and slight decline in memory, language, and thinking functions.

[0006] Patients experience MCI before entering dementia. 15% of MCI patients will develop into dementia after 2 years; approximately 1 / 3 of MCI patients will progress to dementia within 5 years; and approximately 26% of MCI patients will revert to normal cognition.

[0007] After entering the dementia stage, patients will experience significant memory, language, thinking and behavioral abnormalities that affect their daily living abilities, and AD-related biomarkers will also show obvious abnormalities.

[0008] In recent years, photobiomodulation (PBM) has been introduced to treat AD. PBM applies red light or near-infrared light with a wavelength range of 600 to 1100 nm to the head, which passes through the scalp and skull to act on brain tissue. It treats AD non-invasively through multiple mechanisms of action, such as increasing Aβ clearance, reducing abnormal aggregation of Tau protein, improving metabolism and mitochondrial function, increasing cerebral blood flow, and improving anti-oxidative stress and anti-inflammatory capabilities.

[0009] Photobiomodulation devices (also referred to herein as phototherapy devices) from various manufacturers vary significantly in the areas they irradiate, leading to practical issues. For example, many manufacturers' phototherapy devices rely on irradiating the olfactory bulb with near-infrared light via the eye (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) or via the nasal cavity (see Anita E. Saltmarche, et al., Significant Improvement in Cognition in Mild to Moderately Severe Dementia Cases Treated with Transcranial Plus Intranasal Photobiomodulation: Case Series Report, Photomedicine and Laser Surgery, Volume 35, pages 432-441). This means that a significant portion of the efficacy of these devices is attributed to the near-infrared light dose delivered to the olfactory bulb via the eye or nose, and then to the frontal lobe. However, the majority of AD patients are elderly. During research and clinical trials in nursing homes, the inventors found that most elderly individuals have a strong resistance to eye and nasal irradiation, making it difficult to implement. Furthermore, irradiation of the eyes can also bring uncontrollable risks and damage, including but not limited to infrared cataracts, retinal and choroidal damage, damage to photosensitive cells, and corneal damage.

[0010] In addition, some phototherapy devices usually target the default mode network (DMN) with near-infrared light, or the irradiation modules are concentrated in the corresponding area of ​​the occipital lobe without any irradiation to the parietal lobe. The irradiation areas vary and there is no definitive conclusion.

[0011] Currently, regarding the clinical effects of phototherapy equipment, people usually only focus on whether there is a decrease in the ADAS-cog scale score and an increase in the MMSE scale score during treatment. At most, they pay attention to the decrease and increase in the scores, but do not pay attention to the details of the change process: for example, the stagnation of score optimization during phototherapy, or the rapid deterioration and rebound of the patient's cognitive status after the cessation of phototherapy, or the learning effect caused by the short revisit interval.

[0012] Accordingly, the current research on the mechanism of action of phototherapy devices during treatment and even after treatment has stopped is relatively rough. In order to achieve fully optimized treatment effects in a wider range of AD patient populations (from MCI to severe dementia, including those who do not receive nasal and ocular therapy), there is much room for improvement.

[0013] Summary of the Invention

[0014] In view of the above-mentioned problems existing in the prior art, the purpose of this application is to provide a phototherapy device for inhibiting or preventing Alzheimer's disease, which does not rely on nasal and ocular irradiation, and can achieve optimized therapeutic effects for AD patients ranging from MCI to dementia during the treatment course, and can not only effectively maintain but also continuously increase the therapeutic effect when phototherapy is interrupted.

[0015] According to the first aspect of the present application, a phototherapy device for inhibiting or preventing Alzheimer's disease is provided. The phototherapy device includes a supporting structure and an array of near-infrared irradiation units. The supporting structure is constructed to form a storage space for the subject's head and to carry an array of near-infrared irradiation units. The array of near-infrared irradiation units is constructed as follows: near-infrared light is emitted into the storage space, and when the subject's head is in place in the storage space, an irradiation space range is formed covering at least the front upper part of the skull, the top of the skull, the left side of the skull and the right side of the skull on the surface of the subject's head, the time-averaged total irradiation power acting on the skull of the subject's head reaches 27.5W or more, 31W or more, or 40W or more, or 60W or more, or 70W or more, and the spatiotemporal average light power density does not exceed 230mW / cm 2 .

[0016] Compared with the prior art, the beneficial effects of the embodiments of the present application are as follows. The light therapy device is not limited to a specific structure, nor is it limited to whether the near-infrared irradiation unit is an ordinary LED or a low-energy laser diode. It can irradiate near-infrared light of sufficient total power to at least the upper front part of the skull, the top of the skull, together with the left side and the right side of the skull on the surface of the skull of the subject's head, while avoiding nasal and transcranial irradiation that may cause discomfort or resistance in some patients. This irradiation spatial range ensures that the near-infrared light can irradiate the core network nodes and brain areas of the default mode network (DMN), the central executive network (ECN, also known as the executive control network), the salience network (SN), the sensorimotor network (SMN) and the dorsal attention network (DAN). The time-averaged total irradiation power of more than 27.5W is synergistically applied to the above parts of the skull of the subject's head, which can effectively inhibit or cut off the development process of neurodegenerative diseases caused by abnormalities in Aβ plaques and Tau proteins spreading along the brain's functional network. In clinical experiments, it was confirmed that the light therapy device has a certain therapeutic effect on multiple individual AD patients with a course ranging from MCI to dementia. Furthermore, in a clinical trial of approximately 27 patients (including treatment and control groups) with mild and moderate dementia, it was confirmed that the effect of the light therapy device steadily increased during the treatment period, and the treatment effect was maintained during a certain interruption period after each course of treatment. Even the biochemical reactions caused by the previous light therapy continued to trigger an inhibitory effect, and the patient's condition continued to improve. Although the exact mechanism of action is not yet fully understood, the light therapy device of this application does show excellent "light charging depth" and "endurance" capabilities in inhibiting the course of AD, avoiding deterioration callbacks during interruptions, continuously increasing benefits, and patients do not have any adverse reactions.

[0017] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention.

[0018] This application describes an overview of various implementations or examples of the technology, and is not a comprehensive disclosure of the full scope or all of the features of the disclosed technology. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] In the drawings, which are not necessarily drawn to scale, the same reference numerals may describe similar components in different views. The same reference numerals with letter suffixes or different letter suffixes may represent different instances of similar components. The accompanying drawings generally illustrate various embodiments by way of example and not limitation, and together with the description and claims, serve to illustrate the embodiments of the invention. Where appropriate, the same reference numerals are used throughout the drawings to refer to the same or similar parts. Such embodiments are illustrative and are not intended to be exhaustive or exclusive of the embodiments of the present apparatus or method.

[0020] FIG1 is a schematic diagram of the longitudinal cross-sectional structure of a head cap of a light therapy device according to the first embodiment of the present application.

[0021] FIG2 is a schematic diagram of the longitudinal cross-sectional structure of a head cap of a light therapy device according to a second embodiment of the present application.

[0022] FIG3 is a bottom view of the head cap of the light therapy device according to the first or second embodiment of the present application.

[0023] 4( a ) to 4 ( f ) are diagrams showing characteristic parameters of a head of a patient or a reference head model of a group of patients according to a third embodiment of the present application.

[0024] Figure 5(a) shows a front view of a reference head model according to the fourth embodiment of the present application, which serves as an example of an object head. The electrode positions of the 10-10 international standard lead system, the overall boundary line of the reference skull, and the boundary lines between the front upper part of the skull, the left side of the skull, and the right side of the skull are shown on the object head.

[0025] Figure 5(b) shows a left side view of a reference head model according to the fourth embodiment of the present application, which serves as an example of an object head. The electrode positions of the 10-10 international standard lead system, the overall boundary line of the reference skull, and the boundary lines between the front and upper skull, the left skull, the top of the skull, and the back of the skull are shown on the object head.

[0026] Figure 5(c) shows a right side view of a reference head model according to the fourth embodiment of the present application, which serves as an example of an object head. The electrode positions of the 10-10 international standard lead system, the overall boundary line of the reference skull, and the boundary lines between the front and upper skull, the right skull, the top of the skull, and the back of the skull are shown on the object head.

[0027] Figure 5(d) shows a top view of a reference head model according to the fourth embodiment of the present application, which serves as an example of an object head. The object head shows the electrode positions of the 10-10 international standard lead system, the overall boundary line of the reference skull, and the boundary lines between 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.

[0028] Figure 5(e) shows a rear view of a reference head model according to the fourth embodiment of the present application, which serves as an example of an object head. The electrode positions of the 10-10 international standard lead system, the overall boundary line of the reference skull, and the boundary lines between the top of the skull, the left side of the skull, the right side of the skull, and the back of the skull are shown on the object's head.

[0029] FIG5( f ) shows an exemplary diagram of an irradiation area according to a fifth embodiment of the present application.

[0030] FIG6( a ) is a schematic diagram showing electrode positions based on the 10-10 international standard lead system on the upper front part of a reference head model as an example of a subject's head according to the sixth embodiment of the present application.

[0031] FIG6( b ) is a schematic diagram showing electrode positions based on the 10-10 international standard lead system on the upper front part of the skull of a reference head model as an example of a subject's head according to the seventh embodiment of the present application.

[0032] FIG6( c ) is a schematic diagram showing electrode positions based on the 10-10 international standard lead system on the upper front part of the skull of a reference head model as an example of a subject's head according to the eighth embodiment of the present application.

[0033] 7( a ) to 7 ( c ) illustrate the division methods of the front upper part of the skull, the top of the skull, the left side of the skull, and the right side of the skull according to three embodiments of the present application.

[0034] Figure 8 shows a schematic diagram of the spatial locations of the default mode network (DMN), central executive network (ECN, also known as the executive control network), salience network (SN), sensorimotor network (SMN), dorsal attention network (DAN) and visual network (VN) in the brain.

[0035] FIG9 shows a schematic diagram of the arrangement structure of the light board according to the eighth embodiment of the present application.

[0036] FIG10 is a schematic diagram showing the arrangement structure of a light panel frame according to a ninth embodiment of the present application.

[0037] FIG11 is a schematic flow chart showing a clinical experiment on AD patients using a light therapy device according to an embodiment of the present application.

[0038] FIG12( a ) shows a graph showing changes in the ADAS-Cog scale scores of the control group before near-infrared light therapy, during near-infrared light therapy, and after cessation of near-infrared light therapy.

[0039] FIG12( b ) shows a graph showing changes in the ADAS-Cog scale scores of the experimental group before near-infrared light therapy, during near-infrared light therapy, and after cessation of near-infrared light therapy.

[0040] FIG13( a ) shows a graph showing changes in the MMSE scale scores of the control group before near-infrared light therapy, during near-infrared light therapy, and after cessation of near-infrared light therapy.

[0041] FIG13( b ) shows a graph showing changes in the MMSE scores of the experimental group before, during, and after near-infrared light therapy.

[0042] Reference numerals:

[0043] 1-outer shell; 2-middle shell; 3-inner shell; 4-lamp board accommodating cavity; 5-light board; 6-cold air cavity; 7-air vent; 701-upper air vent unit; 702-middle air vent unit; 703-lower air vent unit; 8-cold air inlet; 9-lamp board fixing shell; 10-first layer light board; 11-second layer light board; 12-third layer light board; 13-fourth layer light board; 14-fifth layer light board; 15-sixth layer light board; 16-vent; 17-light board fixing bracket; 18-connecting part. DETAILED DESCRIPTION

[0044] In order to make the purpose, technical solutions and advantages of the embodiments of the present application clearer, the technical solutions of the embodiments of the present application will be clearly and completely described below in conjunction with the drawings of the embodiments of the present application. Obviously, the described embodiments are part of the embodiments of the present application, not all of the embodiments. Based on the described embodiments of the present application, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of this application.

[0045] Unless otherwise defined, the technical or scientific terms used in this application should have the usual meanings understood by people with ordinary skills in the field to which this application belongs. The "first", "second" and similar words used in this application do not indicate any order, quantity or importance, but are only used to distinguish different components. "Include" or "comprise" and similar words mean that the elements or objects appearing before the word include the elements or objects listed after the word and their equivalents, without excluding other elements or objects. "Connect" or "connected" and similar words are not limited to physical or mechanical connections, but may include electrical connections, whether direct or indirect. "Up", "down", "left", "right" and the like are only used to indicate relative position relationships. When the absolute position of the object being described changes, the relative position relationship may also change accordingly.

[0046] The so-called "inhibition or prevention of Alzheimer's disease" in this application is intended to indicate the effect of preventing, reducing the probability, alleviating, inhibiting, terminating or even reversing the course of Alzheimer's disease. The so-called course of Alzheimer's disease is intended to include the clinical symptoms of AD that the subject has already developed and the subsequent development process, as well as the process in which the subject has not yet clearly developed clinical symptoms of AD but has some pathological or physiological phenomena associated with AD and that will develop into AD with a certain probability. In other words, the expression "inhibition or prevention of Alzheimer's disease" in this application includes treating Alzheimer's disease that has already occurred, as well as preventing the occurrence of Alzheimer's disease or reducing the probability of Alzheimer's disease. Specifically, according to the 2018 AD diagnostic criteria of the National Institute on Aging and the Alzheimer's Association (NIA-AA), based on the levels of beta-amyloid protein (Aβ) and tau in the brain or cerebrospinal fluid of the population, as well as the results of cranial MRI and FDG-PET examinations, biomarkers can be divided into four categories, and cognitive function can be further divided into six levels. Level 1 is characterized by normal objective cognitive neuropsychological tests, no cognitive complaints, no neurobehavioral symptoms, no informed reports of cognitive decline or neurobehavioral symptoms, and no follow-up test evidence of cognitive decline; Level 2 includes subjective cognitive decline (SCD), objective mild cognitive decline (Obj-SCD) and neurobehavioral symptoms; Levels 1 and 2 are collectively referred to as the preclinical stage. Level 3 is abnormal or impaired objective cognitive tests, but has not reached dementia, that is, MCI. Levels 4-6 are mild, moderate and severe dementia, respectively. At each of these 6 levels, if there is a positive test result for a biomarker, it can belong to the course of Alzheimer's disease defined in this application. Furthermore, for subjects who carry genes associated with the risk of AD but whose current test results are Aβ-negative, such as APOEε4, ABCA7, CLU, CR1, PICALM, PLD3 and TREM2, even if their cognitive function is at level 1, medical intervention to reduce their risk of AD and slow down their progression to AD can also be regarded as "inhibiting or preventing Alzheimer's disease" in this application.

[0047] Unless otherwise specified, the so-called "skullcap portion of the subject's head" in this application is intended to cover various definitions of "skullcap portion" in the fields of anthropology and medicine. For example, the "skullcap portion" can be the demarcation made by Friess et al. (2002) when measuring the area of ​​the skull. For another example, the plane formed by the upper point between the eyebrows and the upper edge points of the external auditory meatus on both sides can be used as the dividing interface, and the part of the head above the dividing interface is taken as the "skullcap portion". For another example, the "skullcap portion" can also represent the part surrounded by the total boundary line on the surface of the head. The total boundary line can be defined according to the 10-10 international standard lead system as starting from the eyebrows point of the subject's head through the front points of the ears on both sides, circling back through the occipital protuberance and merging with the electrode positions O1, OZ and O2 of the 10-10 international standard lead system.

[0048] In this application, the term "acting on the skull portion of the subject's head" is intended to refer to the outer thin irradiation surface adjacent to the hair (or scalp where there is no hair) of the skull portion of the subject's head (that is, the skull portion of the subject's head). Irradiation of near-infrared light to this outer thin irradiation surface means that the irradiation energy of the near-infrared light is transmitted to the skull portion of the head, including the hair, scalp, skull, and brain tissue. Furthermore, after the transmitted energy is absorbed by the hair and attenuated by the scalp and skull, the remaining energy that can act on the cortex or even deeper parts of the brain tissue is related to the attenuation along the transmission path.

[0049] The so-called "time-averaged total irradiation power" in this application is different from the peak irradiation power, and is intended to indicate the total irradiation power level obtained by averaging the total irradiation energy accumulated over a period of time.

[0050] In this application, the so-called "time-averaged optical power density" is intended to mean the optical power density averaged over time. For example, the "time-averaged optical power density" of a target site is intended to mean the optical power density averaged over time at the target site. For another example, the "time-averaged optical power density" of a target portion is intended to mean the "time-averaged optical power density" of a representative position on the target portion. Specifically, the "time-averaged optical power density" of the target portion is 30-60 mW / cm 2 , which means that the time-averaged optical power density at each representative position on the target part, such as but not limited to the position corresponding to the center of the light board, is 30-60mW / cm 2 fluctuates within the range.

[0051] The so-called "spatiotemporal average optical power density" to the target area is intended to mean the time-averaged optical power density averaged relative to the surface area of ​​the target area, that is, the optical power density after averaging operations are performed relative to both the surface area and time.

[0052] According to the first aspect of the present application, a light therapy device for inhibiting or preventing Alzheimer's disease is provided. The light therapy device may include a supporting mechanism, such as but not limited to the head cap shown in Figures 1 to 3, wherein the supporting mechanism is constructed to form a storage space for the subject's head and to carry an array 5 of near-infrared irradiation units. In some embodiments, the supporting mechanism may adopt a loose head cap as shown in Figures 1 to 3, so that the head of the AD patient maintains an appropriate distance from the inner wall of the head cap when it is in place therein, and the distance is on the order of several centimeters, so as to provide sufficient margin for the movement of the head of the AD patient without causing worry and anxiety to the AD patient due to excessive space. Please note that the so-called "subject's head is in place in the storage space" herein is intended to mean that the subject's head is in a standard treatment position in the storage space, or is within an allowable position deviation range from the standard treatment position. For example, in the standard treatment position, the center of gravity of the subject's head can be aligned with the center of the storage space, and the central axes in the front-to-back direction are aligned with each other. For another example, in the standard treatment position, the subject's head can be centered within the accommodation space, with the front-to-back distances from the front and back walls of the accommodation space being substantially uniform, and the left-to-right distances from the left and right walls of the accommodation space being substantially uniform. For another example, using the phototherapy head cap shown in Figures 1-3 as an example, when in place, the subject's brow bone can be aligned with the front edge of the cap, and the subject's head can be centered within the cap, with the front and back sides of the head cap being substantially uniform, and the left and right sides of the head cap being substantially uniform.

[0053] In some embodiments, the supporting mechanism can also be implemented as a skeleton structure that fits tightly against the head of the AD patient, so that the infrared irradiation unit or its sub-array can be installed as a module on the skeleton structure. In other embodiments, the supporting mechanism can also be implemented as a non-headgear support frame that is farther away from the AD patient's head, using various structures such as arc shape, cone shape, spatial grid shape, etc., as long as it supports the array 5 of near-infrared irradiation units, and no further details are given here.

[0054] The array 5 of near-infrared irradiation units is specifically configured to emit near-infrared light into the accommodation space. When the subject's head is in place in the accommodation space, an irradiation space range is formed covering at least the front upper part of the skull, the top of the skull, the left side of the skull, and the right side of the skull. The time-averaged total irradiation power acting on the skull of the subject reaches more than 27.5W, and the time-space average light power density does not exceed 230mW / cm 2 to avoid the risk of thermal damage.

[0055] In some embodiments, a controller and a driving circuit may be provided in a host computer that is separate from the headgear and wired to the near-infrared irradiation units, so as to control and drive each near-infrared irradiation unit via the wiring to provide the desired time-averaged total irradiation power and spatiotemporal average optical power density. For another example, a controller and a driving circuit may also be provided in the headgear to control and drive each near-infrared irradiation unit to provide the desired time-averaged total irradiation power and spatiotemporal average optical power density.

[0056] Specifically, the frontal superior part of the skull is mainly associated with the frontal lobe, the top of the skull is mainly associated with the parietal lobe, and the left and right sides of the skull are mainly associated with the left and right temporal lobes. However, it should be noted that this association does not only mean a spatial association, but also an association in the brain's functional network connection. In other words, sufficient irradiation of the frontal superior part with near-infrared light can achieve neural regulation of the frontal lobe, and the same is true for other parts. The inventors have found that by applying a time-averaged total irradiation power of more than 27.5W directly to the skull of the subject, and the irradiation space range can cover at least the front upper part of the skull, the top of the skull, together with the left and right sides of the skull, it is possible to irradiate near-infrared light of sufficient energy to the core network nodes and brain areas of the default mode network (DMN), the central executive network (ECN, also known as the executive control network), the salience network (SN), the sensorimotor network (SMN) and the dorsal attention network (DAN), thereby effectively inhibiting or cutting off the development process of neurodegenerative diseases caused by abnormal Aβ plaques and Tau proteins spreading along the brain functional network. The inventors have creatively found that only focusing on the average irradiation power per unit area (that is, the light power level per unit area, mW / cm 2 ) or just focus on the radiation energy (J / cm2) per unit area. 2), and cannot ensure the robust therapeutic effect on AD whole-brain lesions. Specifically, AD is a whole-brain disease, and the lesions are diffused from some areas along the functional connection areas of the brain functional network rather than along spatially related and less connected sites. Furthermore, AD lesions can cause specific cell populations (such as but not limited to astrocytes, microglia, oligodendrocytes, neurons, vascular cells, peripheral glial cells, extracellular matrix, etc.) specific responses. By applying sufficient time-averaged total irradiation power to the cell population, it not only produces a change response that inhibits AD itself, but also can spread and deliver the change response to other cell populations along the functional connection area. Please note that the positioning and range of the upper front skull, the top of the skull, the left side of the skull and the right side of the skull in this application just correspond to or target the core network nodes and brain areas of each of the above-mentioned brain networks, and by irradiating the core network nodes and brain areas of the above-mentioned networks with sufficient time-averaged total irradiation power, the diffusion path along the functional connection area is smoother, and the diffusion and transmission effect of the inhibitory response is also more efficient, thereby achieving an optimized AD inhibition effect across the whole brain. If the process of irradiating near-infrared light to the subject's head is analogous to a battery charging process, such as a "light charging" process, the light therapy device according to this application can make the "light charging capacity" of the subject's brain larger, the "light charging depth" deeper, and the "light charging speed" faster, so the subsequent "endurance" capability (that is, the time it can maintain the therapeutic effect or even continue to increase the therapeutic effect after charging light energy) is also better. In addition to the total power used in the clinical trials on a larger range of subjects described below, the inventors also used multiple levels of total power, such as 31W or above, 40W or above, 60W or above, or 70W or above. Specifically, various total power values ​​from 29W to 135W with 1W intervals are possible. For example, total power levels of 30W, 32W, 34W, 35W, 38W, 45W, 50W, 60W, 65W, 70W, 75W, 80W, 85W, 90W, 95W, 100W, 105W, 110W, 115W, 120W, 125W, 130W, and 135W are also possible. The light therapy effect was tested on individual AD patients and confirmed that no adverse reactions occurred in patients at this range of total power. AD patients also reported that their previous cognitive impairments, such as recent memory loss, muscle stiffness, and weakened spatial ability, were alleviated to a certain extent.

[0057] The subject head includes the head of the patient being treated, or a reference head model of a group of patients being treated.

[0058] In some embodiments, during the manufacturing process of the phototherapy device, a reference head model of the treatment population can be used to simulate the attenuation and transmission of near-infrared light. Specifically, a reference head model with representative dimensions can be selected based on the treatment population. For example, the majority of AD patients are over 60 years old. For the treatment population in this age group, 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 length of 104-130 mm, head sagittal arc of 304-372 mm, intertragus arc of 320-375 mm, and head height of 206-253 mm. These parameters are shown in Figures 4(a) to 4(f).

[0059] Specifically, the parameter range of the reference head model falls within the intersection of the distribution range of the parameter values ​​of P1, P5, P10, P50, P90, P95 and P99 of women in this age group and the parameter values ​​of P1, P10, P50, P90, P95 and P99 of men in this age group. Therefore, it is well representative for both men and women in this age group.

[0060] 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, morphological length of 109.3 mm, sagittal arc of 355.6 mm, intertragus arc of 324.1 mm, and head height of 206 mm. These refined parameters are determined, at least in part, based on the P50 parameter values ​​for females and males of this age group. For example, the head width and head length here are the averages of the two corresponding P50 parameter values. The P50 parameter values ​​for females of this age group are as follows: head width of 149 mm, head length of 180 mm, head circumference of 548 mm, morphological length of 111 mm, sagittal arc of 335 mm, intertragus arc of 342 mm, and head height of 228 mm. The P50 parameter values ​​for males in this age group are as follows: head width 155 mm, head length 188 mm, head circumference 565 mm, morphometric length 121 mm, sagittal arc 343 mm, intertragus arc 351 mm, and head height 231 mm. As can be seen, the parameters of this reference head model have a good agreement with the P50 parameters of females and males in this age group, making it more representative. Furthermore, the cephalo-facial index (CFI) of these parameters is 82%, which is consistent with the CFI range of brachycephaly, the dominant head shape in Chinese (and East Asian) populations. Therefore, the parameters of this reference head model are particularly representative of Chinese and East Asian populations. In some embodiments, the various parameters can also be adaptively adjusted to achieve better representativeness for populations with other CFIs, such as, but not limited to, major human populations in Europe, South Asia, and Africa.

[0061] The light therapy device of the present application has been tested on a variety of reference head models (for example, but not limited to those representing elderly men and women of East Asia, elderly men and women of African descent, etc.), and it has been confirmed that when each reference head model is in place in the accommodation space, it can cover at least the upper front part of the skull, the top of the skull, as well as the left and right sides of the skull, and provide sufficient time-averaged total irradiation power.

[0062] In some embodiments, when manufacturing a phototherapy device, a representative reference headform can be prepared for the target population, and the irradiation spatial range can be verified on the cranial surface of the reference headform. Subsequently, the irradiation spatial range on the cranial surface can be verified for a predetermined range of target populations to ensure that, when the heads of individuals in the target population are seated in the accommodation space, at least the upper frontal portion, the top portion of the skull, and the left and right sides of the skull are adequately covered, and that sufficient time-averaged total irradiation power is received.

[0063] In a fourth embodiment of the present application, the cranium, the front and top of the skull, the left side of the skull, and the right side of the skull are all defined on the subject's head according to the electrode positions of the 10-10 international standard lead system, as shown in Figures 5(a) to 5(e). In Figures 5(a) to 5(f), convex portions are drawn at each electrode position for a clearer presentation, but in some embodiments, the convex portions may not be provided on the surface of the reference head model. The 10-10 international standard lead system is an electrode placement standard for electroencephalogram (EEG) recordings that provides an accurate and consistent way to mark and position electrodes on the head. In other words, the 10-10 system can be applied directly to the subject's head without the need for transcranial placement. This system is an extension of the earlier 10-20 system, which was proposed by the International Electroencephalography Society to standardize electrode positions in EEG recordings.

[0064] In the 10-10 system, electrode placement is based on anatomical landmarks on the head, including the nasion, inion, and pre-auricular points. These landmarks determine the front-to-back and left-to-right midline of the head, allowing for electrode placement based on a 10% ratio.

[0065] The 10-10 system's nomenclature is based on the 10-20 system but provides denser electrode placement, particularly in the base and anterior temporal lobes and the frontal lobe, targeting locations often overlooked in the 10-20 system. Furthermore, the 10-10 system introduces several new electrodes to allow for more precise delineation of brain region boundaries, such as FC, which denotes electrodes between the frontocentral region, FT, which denotes electrodes between the frontotemporal region, CP, which denotes electrodes between the central and parietal regions, and PO, which denotes electrodes between the parieto-occipital regions. The 10-10 system's electrode placement effectively eliminates the influence of individual head shape and size variations, allowing the same electrode to be accurately located in the same brain region across individuals. Its denser electrode placement, particularly in the temporal and frontal lobes, allows for more detailed delineation of the anterior-superior skull, the top of the skull, and the left and right sides of the skull on the surface of the skull (excluding the skull, scalp, and hair). This, in turn, allows for more detailed delineation of individual brain regions (frontal, parietal, and temporal lobes) beneath the skull and dura mater.

[0066] 5(a) to 5(e), the upper front part of the skull 500a, the top of the skull 500b, the left side of the skull 500c and the right side of the skull 500d, together with the back of the skull 500e, are arranged in blocks and are within the total area surrounded by the general boundary line 501. The general boundary line 501 runs from the glabella point of the subject's head (see FIG. 5(a)) through the preauricular points on both sides (see FIG. 5(b) and FIG. 5(c)), and then goes back around the occipital protuberance and merges with the electrode positions O1, OZ and O2 of the 10-10 international standard lead system (see FIG. 5(e)). Please note that in order to make the electrode positions clearer, the application identifies the small protrusion and the name of the electrode position at each electrode position, but it should be noted that the small protrusion may not exist.

[0067] Total boundary line 501 can be used for defining the skull surface, that is to say, the area of ​​the total region that total boundary line 501 surrounds is exactly the total surface of skull surface.Though in Fig. 5 (a)-Fig. 5 (e), front upper part 500a of skull, top of skull 500b, left side of skull 500c and right side of skull 500d, together with back of skull 500e have occupied whole total region, but this is only as an example, and these portions can only occupy the part of total region.For example, occupy more than 60% of its surface, or more than 70%, or more than 80%.For another example, the ratio that these portions occupy the surface of total region can be in 60% to 100% scope, with in each percentage ratio of 1% distribution at intervals any one.

[0068] In some embodiments, the front upper portion 500a, the top portion 500b, together with the left side 500c and the right side 500d of the skull are within a first region demarcated from the total region by the fifth boundary line 502a, and occupy more than 60%, or more than 70%, or more than 80% of the surface area of ​​the first region (see FIG5(e)). According to the 10-10 standard lead system, the fifth boundary line 502a passes sequentially between the following electrode positions (see FIG5(b), FIG5(c), and FIG5(e)): 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. The phrase "passing between electrode positions A and B" in this application is intended to mean passing through intermediate points on the line connecting electrode positions A and B. For example, the intermediate point can be the midpoint of the connecting line, or it can be at another point on the connecting line, such as a point at a 1:2 ratio from electrode positions A and B. In some embodiments, for the same boundary line, such as the fifth boundary line 502a, the points passing between paired electrode positions can be at different ratios on the connecting line, so that the sequentially connected boundary lines are smooth. By delivering sufficient time-averaged irradiation power, such as 27.5 W or more, 31 W or more, 40 W or more, 60 W or more, or 70 W or more, to more than 60% of the surface area of ​​the first region, the core network nodes and brain regions of the default mode network (DMN), central executive network (ECN, also known as the executive control network), salience network (SN), sensorimotor network (SMN), and dorsal attention network (DAN) can be substantially covered, or occasionally deviated. Sufficient irradiation power also ensures that the irradiation power component at the deviated nodes breaks through the spatial gap and spreads to the adjacent core network nodes and brain regions.

[0069] Furthermore, allowing the front upper skull 500a, the top skull 500b, along with the left and right skull 500c and 500d, to collectively share sufficient time-averaged irradiation power eliminates reliance on ocular and nasal irradiation, resulting in a more comfortable and relaxing treatment experience for the patient. For example, when using a light-guiding comb such as the present inventor's, separating dark hair on the forehead, top skull, and sides of the skull creates a hair-free, clear area on the scalp, optimizing near-infrared light transmission. Specifically, the transmittance of dense, dark hair and the scalp can be increased by 20-30%. However, the separated and gathered hair tends to be combed back, ultimately overlapping the occipital region. Once reliance on the occipital region (corresponding to the back skull 500e) is eliminated, the irradiation range, as shown in FIG5(f), can be better separated to improve transmittance, achieving dark hair on the front upper skull 500a, the top skull 500b, along with the left and right skull 500c and 500d. Furthermore, given the complex curved shape of the occipital part, which is slightly lower and partially concave, the surrounding near-infrared light can be easily blocked in large quantities unless the irradiation unit is set closely. This was also verified when the irradiation test was carried out using the light therapy equipment shown in Figures 1-3 of the present application: the near-infrared irradiation scheme was modified to increase the light power density at the upper front part 500a of the skull, the top part 500b of the skull, together with the left side 500c and the right side 500d of the skull. Compared with increasing the light power density at the back part 500e of the skull, the effect is significantly better and the modification difficulty is lower.

[0070] In some embodiments, the anterior superior skull 500a, the top of the skull 500b, together with the left skull 500c and the right skull 500d, can also be divided as follows so that each part corresponds more accurately to the core network nodes and brain areas covering the default mode network (DMN), central executive network (ECN), salience network (SN), sensorimotor network (SMN) and dorsal attention network (DAN).

[0071] In some embodiments, the front upper cranial portion 500a, the top of the cranial portion 500b, the left side of the cranial portion 500c, and the right side of the cranial portion 500d can be divided according to their boundary lines. Specifically, within a first subregion enclosed by a first boundary line 502b and the overall boundary line 501, the front upper cranial portion 500a sequentially passes between the following electrode positions according to the 10-10 standard lead system: between F7 and FT7, between F5 and FC5, between FC3 and C3, between FC1 and C1 (see Figure 5(b)), between FCZ and CZ (see Figure 5(d)), between FC2 and C2, between FC4 and C4, between F6 and FC6, and between F8 and FT8 (see Figure 5(c)). In some embodiments, the front upper cranial portion 500a occupies more than 60%, or more than 70%, or more than 80% of the surface area of ​​the first subregion. Taking the upper front part of the skull 500a as an example, it can adopt a block method that surrounds the electrode positions in groups (see Figure 6(a)), or adopt a connected domain method with multiple openings (see Figure 6(b), the opening positions can correspond to the electrode positions or not correspond to the electrode positions) to achieve the desired percentage relative to the surface area of ​​the first sub-region. In some embodiments, the upper front part of the skull 500a can also be covered with the first sub-region (see Figure 6(c)) to achieve blind spot-free irradiation of the first sub-region. This can also be applied to other parts, such as the top of the skull 500b, together with the left side of the skull 500c and the right side of the skull 500d, which will not be repeated here.

[0072] In some embodiments, the top of the skull 500b is within a second sub-region surrounded by a second boundary line 502c. According to the 10-10 standard lead system, the second boundary line 502c 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 (see FIG5(d)), between C6 and C4, between CP6 and CP4, between P6 and P4 (see FIG5(c)), 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 (see FIG5(e)), between P5 and P3, between CP5 and CP3, and between C5 and C3 (see FIG5(b)), and the top of the skull 500b occupies more than 60%, or more than 70%, or more than 80% of the surface area of ​​the second sub-region.

[0073] In some embodiments, the left cranial side 500c is within a third sub-region bounded by a third boundary line 502d and the overall boundary line 501, and the right cranial side 500d is within a fourth sub-region bounded by a fourth boundary line 502e and the overall boundary line 501. According to the 10-10 standard lead system, the third boundary line 502d sequentially passes between the following electrode positions (see FIG. 5( b )): 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, and the fourth boundary line 502e sequentially passes between the following electrode positions (see FIG. 5( c )): 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. Specifically, the left side of the skull 500c occupies more than 60%, or more than 70%, or more than 80% of the surface area of ​​the third sub-region, and the right side of the skull 500d occupies more than 60%, or more than 70%, or more than 80% of the surface area of ​​the fourth sub-region.

[0074] In some embodiments, the front upper cranial portion 500a, the top cranial portion 500b, along with the left cranial portion 500c and the right cranial portion 500d, can be divided according to the sets of electrode positions they contain. For example, according to the 10-10 standard lead system, see Figure 7(a), each portion can respectively contain the following electrode positions. The front upper cranial portion 500a includes electrode positions FP2, FPZ, FP1, AF3, AF4, AF7, AF8, AFZ, FZ, F1, F2, F3, F4, F5, F6, F7, F8, FC1, FC2, FC3, FC4, and FCZ. The top cranial portion 500b includes electrode positions CZ, C1, C2, C3, C4, CPZ, CP1, CP2, CP3, CP4, PZ, P1, P2, P3, and P4. The left side of the skull 500c includes electrode positions FT7, FC5, T7, C5, TP7, CP5, P7, and P5, and the right side of the skull 500d includes electrode positions FT8, FC6, T8, C6, TP8, CP6, P8, and P6.

[0075] In some embodiments, each portion may include more sparsely spaced electrode locations, i.e., narrower coverage. For example, according to the 10-10 standard lead system, the anterior superior cranial portion 500a may include electrode locations AFZ, FZ, F1, F2, FP1, and FP2. The top of the skull 500b may include electrode locations CZ, C1, C2, and CPZ. The left side of the skull 500c may include electrode locations FT7, FC5, T7, and C5, or TP7, CP5, P7, or P5, and the right side of the skull 500d may include electrode locations FT8, FC6, T8, and C6, or TP8, CP6, P8, and P6. Although the coverage of each part has been shrunk, by providing sufficient time-averaged irradiation power to each part, it is still possible to break through the spatial interval and spread to the default mode network (DMN), central executive network (ECN, also known as executive control network), salience network (SN), sensorimotor network (SMN) and dorsal attention network (DAN) in the nearby core network nodes and brain areas, thereby performing AD inhibition processing along the diffusion path of the functional connection area, such as inhibiting or eliminating the deposition of Aβ plaques, inhibiting or eliminating the abnormal aggregation of Tau protein, inhibiting or improving the tangling of neuronal fibers, and thus effectively inhibiting or cutting off the development process of neurodegenerative diseases caused by abnormal Aβ plaques and Tau protein spreading along the brain functional network.

[0076] In some embodiments, the front upper part of the skull 500a, the top of the skull 500b, together with the left side of the skull 500c and the right side of the skull 500d, can be divided into multiple groups as needed based on the set of electrode positions included. Please note that this division can be for the convenience of light control of the light therapy device, or for the specific structure of the light therapy device - especially the spatial arrangement of each unit in the array of near-infrared irradiation units. Thus, the front upper part of the skull 500a, the top of the skull 500b, together with the left side of the skull 500c and the right side of the skull 500d, each containing a set of electrode positions, can be flexibly divided as long as it can cover or be sufficiently close to the core network nodes and brain regions of the default mode network (DMN), the central executive network (ECN, also known as the executive control network), the salience network (SN), the sensorimotor network (SMN) and the dorsal attention network (DAN).

[0077] For example, according to the 10-10 standard lead system, the division of each part can be seen in Figure 7(b). The front upper part 500a includes FP2, FPZ, FP1, AF3, AF4, AF7, AF8, AFZ, FZ, F1, F2, F3, F4, F5, F6, F7, FC5, F8, FC1, FC2, FC3, FC4, FCZ, FC6, CZ, C1, C2; the top part 500b includes electrode positions C5, C3, C4, C6, CPZ, CP1, CP2, CP3, CP4, CP5, CP6, PZ, P1, P2, P3, P4. The left side of the skull 500c includes electrode positions FT7, T7, TP7, P7, and the right side of the skull 500d includes electrode positions FT8, T8, TP8, P8.

[0078] For another example, according to the 10-10 standard lead system, the division of each part can be seen in Figure 7(c). The front upper part 500a of the skull includes electrode positions FP2, FPZ, FP1, AF3, AF4, AF7, AF8, AFZ, FZ, F1, F2, F3, F4, F5, F6, FC1, FC2, FC3, FC4, FC5, FC6, FCZ, CZ, C1, and C2. The top part 500b of the skull includes electrode positions C3, C4, C5, C6, CPZ, CP1, CP2, CP3, CP4, CP5, CP6, PZ, P1, P2, P3, and P4. The left side of the skull 500c includes electrode positions F7, FT7, T7, TP7, and P5, and the right side of the skull 500d includes electrode positions F8, FT8, T8, TP8, and P6.

[0079] Figure 8 shows a schematic diagram of the spatial locations of the default mode network (DMN), central executive network (ECN, also known as the executive control network), salience network (SN), sensorimotor network (SMN), dorsal attention network (DAN), and visual network (VN) in the brain. As shown in Figure 8 , the anterior DMN sites include the medial prefrontal cortex, anterior cingulate gyrus, dorsal prefrontal cortex, and lateral temporal lobe, while the posterior sites include the medial temporal lobe, hippocampus, angular gyrus, inferior parietal lobule, posterior cingulate gyrus, and ventral prefrontal cortex. More than a decade before the onset of recognizable cognitive states, beta-amyloid (Aβ) begins to significantly accumulate in the DMN, and spreads along functionally connected regions of the DMN rather than along spatially related and less connected sites. In patients with dementia and MCI, brain functional networks often show damage in the posterior cingulate gyrus, medial temporal lobe (particularly hippocampal nodes), and posterior parietal lobe. In MCI patients, Aβ is first deposited in the posterior cingulate gyrus, prefrontal cortex, precuneus, and parietotemporal lobes, weakening functional connectivity between these regions and other brain regions. These lesion sites are fully covered by the anterior superior cranial region 500a, the top of the skull 500b, the left side of the skull 500c, and the right side of the skull 500d.

[0080] The salience network (SN), also known as the ventral attention network, and the dorsal attention network (DAN) collaborate to form the attention network (AN). The salience network is primarily distributed in the anterior cingulate gyrus, frontal insular cortex, and ventral prefrontal cortex. Abnormal increases in its internal function are associated with damage to its functional network, leading to symptoms of abnormal mental activity in AD patients, especially those in the dementia stage, such as, but not limited to, irritability, abnormal motor behavior (constant walking), anger, and aggressive behavior. In fact, weakened specific functional connectivity in the DMN compensates for increased functional connectivity related to the SN, such as enhanced connectivity between the right anterior cingulate gyrus and the SN. The DAN, on the other hand, is primarily distributed in the intraparietal sulcus and frontal oculomotor area. Reduced functional connectivity between the DAN and SN is also closely associated with attention deficits in AD patients. Specifically, both the DAN and SN are impaired in AD patients, while in MCI patients, DAN function is impaired while the internal functional connectivity of the SN is somewhat preserved. Referring to Figure 8, the upper front part 500a, the top of the skull 500b, the left side of the skull 500c and the right side of the skull 500d fully cover the frontal lobe, especially the part adjacent to the temporal lobe, and the parietal lobe, thereby fully covering the important sites where lesions occur in the SN and DAN of AD patients.

[0081] The central executive network (ECN, also known as the executive control network) is mainly distributed in the dorsolateral prefrontal cortex, ventral prefrontal cortex, medial prefrontal cortex, parietal cortex, etc., see Figure 8. In the early stages of AD, the functional connectivity pattern of the ECN has changed. For example, the functional connectivity between the left frontal cortex and other brain regions is reduced, and the functional connectivity of the left parietal cortex is reduced, which is associated with visual spatial impairment. For example, in patients during the dementia and MCI stages, the functional connectivity of the right frontal lobe and superior frontal gyrus in the ECN is significantly reduced, which is associated with cognitive impairment. Not only is the internal functional connectivity in the ECN reduced, but the functional connectivity between it and the DMN is also reduced, leading to the spread of impaired executive control function. The anterior superior cranium 500a, the top of the skull 500b, the left side of the skull 500c, and the right side of the skull 500d can fully cover these lesion sites.

[0082] The sensorimotor network (SMN) is responsible for body perception and movement, mainly including the precentral gyrus and the postcentral gyrus, see Figure 8. It is mainly distributed in the adjacent areas before and after the central sulcus, and extends to the temporal lobe on both sides along the central sulcus. Impaired functional connectivity of the SMN leads to movement disorders in AD patients. In addition, for patients in the dementia and MCI stages, the reduction in functional connectivity between the SMN and the DAN is also closely related to attention deficit; as the course of AD worsens, the internal functional connectivity of the SMN deteriorates, and the functional connectivity between the SMN and the DAN also deteriorates. The upper front part 500a and the top of the skull 500b tightly cover the adjacent areas before and after the central sulcus, and in collaboration with the left side of the skull 500c and the right side of the skull 500d, they also achieve vertical direct access to the temporal lobe, fully covering these lesion sites.

[0083] Unlike those phototherapy devices that lack the top of the skull and only focus on the DMN, the phototherapy device of the present application ensures that sufficient time-averaged irradiation power is fully applied to the core sites of lesions in the default mode network (DMN), central executive network (ECN, also known as executive control network), salience network (SN), sensorimotor network (SMN), and dorsal attention network (DAN). Furthermore, the phototherapy device of the present application finely divides the upper front part 500a of the skull, the top of the skull 500b, the left side of the skull 500c, and the right side of the skull 500d according to the 10-10 standard lead system, ensuring that the sites at the junction of brain regions in the above-mentioned networks, as well as the sites that are interconnected between different functional networks, are precisely located, thereby reducing the lack or omission of the active sites in the network. As a result, the irradiation of the near-infrared light applied by the phototherapy device of the present application has a smoother diffusion path along the functional connection area, and the diffusion and transmission effect of the inhibitory response is also more efficient, thereby achieving an optimized AD inhibition effect across the entire brain. If the process of irradiating near-infrared light to the subject's head is compared to the battery charging process, for example, it is called the "light charging" process, according to the light therapy device of the present application, because the core sites of DMN, ECN, SN, SMN, and DAN where AD lesions occur are fully "light charged", the "light charging capacity" of the subject's brain can be larger, the "light charging depth" is deeper, and the "light charging speed" is faster. The subsequent "endurance" capability, that is, the biochemical reaction is still continuously triggered after the light therapy is interrupted, so as to achieve continuous benefits and cumulative benefits, which are also better. This effect has also been verified by clinical experimental results, which will be described in detail below.

[0084] In some embodiments, the irradiated spatial range also covers the posterior cranial region 500e, which is within the fifth subregion divided from the total region by the fifth boundary line 502a, and the fifth subregion is located below the first region. Referring to FIG5(e), the first region is above the fifth boundary line 502a, and the fifth subregion is below the fifth boundary line 502a. The posterior cranial region 500e can occupy the entire fifth subregion, as shown in FIG5(e), or it can occupy only a portion of the fifth subregion.

[0085] In some embodiments, the posterior skull portion 500e may also be defined by the electrode positions it contains, for example, the posterior skull portion 500e may include electrode positions PO7, PO5, PO3, POZ, PO4, P06, PO8, O1, OZ, and O2.

[0086] In some embodiments, the posterior skull portion 500e may also be defined by anatomical feature points. For example, the posterior skull portion 500e may at least include the occipital region above the external occipital protuberance.

[0087] In some embodiments, the time-averaged total irradiation power directly applied to the head of the subject can be higher as needed, for example but not limited to 31 W or more, or 40 W or more, or 60 W or more, or 70 W or more, or even higher, but the time-space average optical power density cannot exceed 230 mW / cm 2 , to avoid thermal damage to brain tissue.

[0088] The light therapy device shown in Figures 1-3 is an example of a loose-fitting headgear. Specifically, its supporting mechanism includes a cover body disposed in mid-air, the cover body being shaped to form a cavity. When the subject's head is seated in the accommodation space, the cavity is sized to accommodate the subject's head in a loose manner without applying pressure to the subject's head. This allows subjects who cannot tolerate confined spaces to feel more free and comfortable during light therapy. Each near-infrared irradiation unit in the first group has a preset emission angle and a preset spacing and height configuration, so that multiple convergence areas are formed above the top of the skull and the upper front of the skull. Near-infrared light from several near-infrared irradiation units with different incident angles converges at each convergence area. Comparing Figures 1-3 with Figure 5(d), the area above the skull includes both the top of the skull and a portion of the upper front of the skull, and the area above the skull is not blocked by other parts of the head. In some embodiments, for black or dark hair, a light-guiding comb can be used to separate and bundle the hair above the skull to further improve light transmittance.

[0089] In some embodiments, the corresponding near-infrared irradiation units above the top of the skull and the front upper part of the skull are arranged along the arched curved surface, and when the subject's head is in place in the accommodation space, the first average distance between the top of the skull and the front upper part of the skull and the corresponding near-infrared irradiation units 5 is greater than the predetermined average distance, so that through the convergence of multiple light beams, the spatiotemporal average light power density at the convergence area above the top of the skull and the front upper part of the skull is at a high level, for example, 58 mW / cm 2 Above 60mW / cm 2 Above, 62mW / cm 2 Above, 64mW / cm 2 Above, 66mW / cm 2 Above, 68mW / cm 2 Above 70mW / cm 2 Above 72mW / cm 2 Above, etc.

[0090] The phototherapy device shown in Figures 1-3 also illustrates an application of a circumferential array of near-infrared irradiation units at multiple heights. Specifically, the support mechanism comprises a housing disposed in mid-air, shaped to form a cavity. The housing supports at least three groups of near-infrared irradiation units at different heights, each group circumferentially spaced at a corresponding height. This circumferential spacing ensures a stable therapeutic effect when the subject's head rotates in place, and also maintains a balanced and stable therapeutic effect across different circumferential locations and regions of the head.

[0091] Different from the design that covers the joint of the subject's head and neck within the cover, the head cap shown in Figures 1 to 3 adopts a "cap" structure rather than a "helmet" structure. Specifically, the cross-sectional area of ​​the cavity formed by the cover increases as it goes downward. When the subject's head is in place in the accommodation space, the bottom of the cover is located on both sides at the tragus or its periphery (for example, 5 cm around the tragus). 2 In this way, the subject's vision is not blocked, and the external occipital protuberance with the largest diameter is adequately spaced from the inner wall, just like wearing a hat instead of being enclosed in it, thus reducing the subject's psychological pressure. This gradually expanding downward cavity makes it difficult for the subject to touch the inner wall when the body slides down due to fatigue or suddenly raises the head, thereby avoiding local high temperature caused by blocking the air outlet on the inner wall and also avoiding touching the high-temperature area on the inner wall.

[0092] The structure of Figures 1 to 3 shows an example in which a light-transmitting protective portion is included in the cover body. The cover body includes a light-transmitting protective portion, for example, the inner shell 3 is made of a light-transmitting material to form the light-transmitting protective portion. The light-transmitting protective portion forms a front upper portion, a top portion, a back portion, a left portion and a right portion, and surrounds the cavity. With this light-transmitting protective portion, the subject's head can be protected from direct contact with the near-infrared irradiation unit. In some embodiments, the front upper portion is arranged correspondingly to the front upper portion of the skull, the top portion is arranged correspondingly to the top of the skull, the back portion is arranged correspondingly to the back of the skull, the left portion is arranged correspondingly to the left side of the skull, and the right portion is arranged correspondingly to the right side of the skull. In some embodiments, the near-infrared light emitted from the top, front upper portion, back portion, left portion and right portion of the light-transmitting protective portion forms an irradiation curved surface without holes on the surface of the skull of the subject's head. In this way, the near-infrared light beam emitted from the array of near-infrared irradiation units and emitted through the light-transmitting protective part has no blind spots and can provide comprehensive radiation to all parts of the subject's skull, thereby not only being applied transcranially and comprehensively to the core sites of lesions in the default mode network (DMN), central executive network (ECN, also known as executive control network), salience network (SN), sensorimotor network (SMN), and dorsal attention network (DAN), but also ensuring that it is fully applied to the sites on the functional connection paths between these core sites.

[0093] For example, the light-transmitting protection portion may be an integrated shell, and all inner walls of the light-transmitting protection portion emit near-infrared light.

[0094] Below, we will describe an example structure of a light therapy device (particularly a head cap) with reference to Figures 1-3. However, it should be noted that the head cap structures shown in Figures 1-3 are merely examples, and the light therapy device of this application may employ different structures. The various structures of the light therapy device defined in the claims, as well as the descriptions of the various components and parts of the light therapy device in the specification, may be used independently or in combination with each other as embodiments of the light therapy device of this application, and are not described in detail here.

[0095] As shown in Figures 1 and 2, an embodiment of the present application provides a head cap for a light therapy device. The head cap includes an outer shell 1, a middle shell 2, and an inner shell 3, which are arranged in sequence from the outside to the inside. A light board receiving cavity 4 with multiple light boards 5 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. The inner shell 3 is enclosed inward to form a receiving space. In some embodiments, each light board can include 4-9 near-infrared LEDs, the time-averaged optical power of each near-infrared LED is 80mw-100mw, and the irradiation area of ​​each near-infrared irradiation unit is 5-9cm 2 .

[0096] In some embodiments, the phototherapy device may further include a cooling mechanism, and the cooling mechanism is configured to: when the time-averaged total irradiation power irradiated to the subject's head reaches 27.5-120W and the single continuous irradiation duration reaches 30 minutes, the temperature of the air in the space adjacent to but not in contact with the subject's head does not exceed 41°C. The cooling mechanism can adopt various different structures. The cooling mechanism in the phototherapy device of the present application introduces cold air from the outside, and utilizes heat transfer under the temperature difference between the cold air and the thermal environment around the subject's head in the accommodation space while the gas is convection, to achieve efficient cooling. Taking Figures 1 to 3 as an example, the cooling mechanism can adopt a design of introducing cold air from the outside, and entering the accommodation space from the air vent 7 through the cold air cavity 6, but it should be noted that other cooling mechanisms are also possible.

[0097] Among them, a plurality of air holes 7 are provided on the inner shell 3 so that the cold air passing through the cold air cavity 6 can enter the accommodating space from the air holes 7. The inner shell 3 can be provided with air holes 7 in the first area close to the top of the head and the second area below the first area. The second area is layered with a plurality of air hole units from top to bottom. Among them, the arrangement of the upper air hole units and the lower air hole units is different, so as to be able to better cool down the various areas of the patient's head, cool down the various brain areas in time, improve the synchronization of cooling, and make the temperature felt by the entire head more balanced during the patient's light therapy, thereby improving the comfort of the patient when wearing the head cap for light therapy.

[0098] Among them, the inner shell 3 is the shell layer closest to the patient's head when worn by the patient, a cold air cavity 6 is formed between the middle shell 2 and the inner shell 3, and the outer shell 1 and the middle shell 2 form a lamp board accommodating cavity 4, wherein the inner shell 3 and the middle shell 2 are configured to be translucent, and the light emitted by the lamp board 5 can pass through the translucent middle shell 2 and inner shell 3 in turn into the accommodating space to perform light therapy on the patient.

[0099] In this embodiment, the inner shell 3 includes two parts: a first area close to the top of the head and a second area below the first area. Air holes 7 may be provided on the first area and the second area. As shown in Figure 3, a cold air inlet 8 communicating with the cold air cavity 6 is provided on the middle shell 2. A circle of air holes may be provided on at least the outer edge of the first area, and a cavity may be reserved for a protective pad on the top of the head. In this way, after the cold air enters the cold air cavity 6 through the cold air inlet 8, it is blown toward the patient's head through the air holes 7 to ensure that the patient has a better cooling experience around the head and on the top of the head during light therapy. In addition, the above structure enables the cold air to flow from the patient's head from top to bottom, which is beneficial to improving the heat exchange efficiency in the accommodation space and making the temperature in the head cap accommodation space more uniform.

[0100] In some embodiments, the cold air inlet 8 of the cold air cavity 6 is arranged in the first area and is closer to the rear of the inner shell 3 than to the front of the inner shell 3, wherein the front of the inner shell 3 is the direction of the forehead corresponding to the head cap, and the rear of the inner shell 3 is the direction of the back of the head cap. As shown in Figures 1 and 2, the cold air inlet 8 shown in Figure 2 is closer to the rear of the inner shell 3. The cold air inlet 8 is arranged closer to the rear of the inner shell 3 than to the front of the inner shell 3, so that the distance from the cold air inlet 8 to 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 distance from the cold air inlet 8 to the end of the rear of the inner shell 3 (i.e., the edge position of the rear of the inner shell 3) are close, thereby avoiding the problem that the cold air inlet 8 is improperly positioned, resulting in a large difference in distance from the edge positions of the front and rear of the inner shell 3, resulting in untimely cooling of some areas and uneven overall cooling.

[0101] In other embodiments of the present application, to ensure that the cold air inlet 8 can evenly transmit cold air to the accommodating space through the air vents 7 of the cold air cavity 6, the headgear for the phototherapy device may include multiple cold air inlets 8, which are distributed at different positions of the inner shell to fill the cold air cavity 6 with cold air, thereby improving the uniformity of cooling the headgear as a whole. The position of the cold air inlet 8 can be adjusted accordingly based on the specific headgear structure and the layout of the phototherapy light panel.

[0102] In the present application, the first area of ​​the inner shell 3 and the second area below it are both provided with air vents 7, which are beneficial to reducing the temperature at the top of the patient's head and the area around the head. In addition, the position / number of the cold air inlet 8 is adjusted so that it is located in the first area, which can ensure effective cooling at the top of the head, and the arrangement position is closer to the back of the inner shell 3 than the front of the inner shell 3, so that the time for the cold air to reach the front end and the rear end of the inner shell 3 is similar, which can coordinate the cooling of various brain regions, and make the temperature felt by the entire head more balanced during the patient's light therapy, so that the forehead area will not be overcooled, and the back of the head area can feel a better cooling effect, thereby improving the patient's comfort when wearing the head cap for light therapy.

[0103] As shown in Figures 2 and 3, in some embodiments, the second region is layered with multiple air vent units from top to bottom. The upper air vent units 701 and lower air vent units 703 are arranged differently, while the upper air vent units 701 and middle air vent units 702 are arranged in the same manner. The number of air vents in a single lower air vent unit 703 is less than the number of air vents in a single upper air vent unit 701 or middle air vent unit 702, and air vents 7 are arranged between adjacent upper air vent units 701 at a relatively lower air vent density than in the upper air vent units 701. This arrangement allows the upper air vent units 701 and middle air vent units 702 to release more cold air than the lower air vent units 703.

[0104] In some embodiments, the upper air pore unit 701 and the middle air pore unit 702 can both be composed of an inner circle of evenly distributed air pores 7 and an outer circle of evenly distributed air pores 7, for example, 6 air pores 7 evenly distributed in the inner circle and 6 air pores 7 evenly distributed in the outer circle, while the lower air pore unit 703 can be composed of only one circle of evenly distributed air pores 7, for example, only 6 evenly distributed air pores 7.

[0105] In some embodiments, air holes 7 with a relatively lower density of air holes 7 than those in the upper air hole units 701 are further provided between adjacent upper air hole units 701. As shown in FIG3 , the air holes 7 provided between the upper air hole units 701 are relatively sparse. No other air holes 7 are provided between the middle air hole units 702 and the lower air hole units 703.

[0106] Because when the patient wears the head cap for light therapy, the air permeability of the head cap is different from top to bottom. The skin at the top of the patient's head is in the accommodation space and is relatively closed, while the skin at the back of the patient's head is closer to the connection position between the accommodation space and the outside, which is conducive to air exchange. Therefore, more air holes are set at the positions where the air flow is poor to increase the cooling rate, and relatively fewer air holes are set at the positions where the air flow is good, so as to utilize the external environment for heat dissipation, and utilize the principle that cold air moves downward and hot air moves upward, so as to achieve the best cooling effect on the patient's head under the premise of releasing an equal amount of cold air into the accommodation space through the cold air cavity. The arrangement of the air vent units can balance the temperature from top to bottom as much as possible, and increase the comfort during light therapy. Furthermore, in the air vent units of each layer, the spacing between adjacent air vent units can be the same.

[0107] In some embodiments, the ventilation holes 7 are provided at least at positions corresponding to the positions where the light panels 5 are provided. During light therapy, the light panels 5 irradiate the patient's skin. Due to the high intensity of the light, heat accumulation is more likely to occur. Providing the ventilation holes 7 on the inner housing 3 at least at positions corresponding to the positions of the light panels 5 can prevent the light panels 5 from irradiating the patient's skin and generate significant heat accumulation, thereby efficiently transferring the accumulated heat.

[0108] In some embodiments, the density of the air holes 7 at the position corresponding to the light board 5 is greater than the density of the air holes 7 at the position where the light board 5 is not provided. This is conducive to more balanced temperature between the position where the light board 5 is not provided and the position where the light board 5 is provided, which can effectively enhance the air permeability of the accommodation space of the headgear, improve the air heat exchange efficiency in the accommodation space, and further improve the wearing comfort of the patient.

[0109] In some embodiments, a plurality of lamp panels 5 are arranged on the middle shell 2 via a lamp panel fixing shell 9, and the lamp panel fixing shell cover 9 is provided on the side of the middle shell 2 close to the outer shell 1. As shown in FIG9 , in some embodiments, a lamp panel fixing shell 9 is provided in the lamp panel accommodating cavity 4, and the lamp panel fixing shell 9 is covered on the side of the middle shell 2 close to the outer shell 1. 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 that an effective time-averaged radiation dose is delivered to various parts of the surface of the subject's skull, that is, the upper front part of the skull, the top of the skull, the left side of the skull, and the right side of the skull (optional posterior skull), thereby providing a sufficient and effective time-averaged radiation dose to the core sites and regions of the subject's brain functional network through the cranium.

[0110] Specifically, the spatiotemporal average optical power density irradiated to the top of the skull and the upper front of the skull is 55 mW / cm 2 The time-space average optical power density irradiated to the left and right sides of the skull is 35 mW / cm 2 In some embodiments, it can be understood that when multiple light panels 5 are distributed on a spatial curved surface covering the subject's head with a predetermined gap, the spatiotemporal average light power density obtained based on the time-averaged light power density irradiated to each representative position of the top and front upper skull is higher than the spatiotemporal average light power density obtained based on the time-averaged light power density irradiated to each representative position of the left and right skull. This is particularly applicable to the array of surround-type multi-height near-infrared irradiation units and the loose headgear design shown in Figures 1-3. Specifically, although such a design is highly acceptable to AD patients who dislike restraint, it is prone to occlusion of the left and right skull parts, or a weak superposition effect, resulting in low light power density. By allowing the top skull part, which can fully concentrate near-infrared light, and the front upper skull part, which has less hair and is not obstructed, to share as much of the light power density as possible, benefiting from the largest surface area of ​​these two parts, it is possible to provide an overall higher power to the front upper skull, top skull, left skull part, and right skull part. Moreover, there are more core sites and areas of the brain functional network corresponding to the upper front and top of the skull, so it can achieve efficient "light charging" of the core sites and areas of the brain functional network that are prone to AD lesions. The applied near-infrared light irradiation energy has a smoother diffusion path along the functional connection area, and the diffusion and transmission effect of the inhibitory response is also more efficient, thereby achieving optimized AD inhibition effect throughout the brain.

[0111] In some embodiments, the posterior skull can also be selectively included in the irradiation space range, and the spatiotemporal average optical power density irradiated to the posterior skull can be reduced to, for example, 1-30 mW / cm 2Through a large number of irradiation tests, the inventors found that the time-averaged optical power density on the back of the skull has a large deviation. See the structures in Figures 1 to 3. Especially for the loose-fitting headgear design, the back of the skull corresponds to the occipital region, is relatively low in position, and has a concave curved surface. This three-dimensional structure can easily block the near-infrared light directed there. Moreover, the three-dimensional height fluctuations at various locations can also cause this blocking to be more variable. For example, the time-averaged optical power density at various locations can be as low as a few mW / cm 2 , and may be as high as 30 or even 40 mW / cm 2 , resulting in instability in the spatiotemporal average light power density on the posterior part of the skull. In response to this, in the head cap structure of the light therapy device of the present application, even if the posterior part of the skull is covered, the spatiotemporal average light power density irradiated to the top of the skull and the upper front part of the skull, as well as the spatiotemporal average light power density irradiated to the left and right sides of the skull, are (significantly) higher than the spatiotemporal average light power density irradiated to the posterior part of the skull. In other words, the spatiotemporal average light power density and the total irradiation power are shared as little as possible by the posterior skull, which is subject to variable occlusion, so that the AD inhibition or prevention effect on the subject can still be ensured.

[0112] In some embodiments, the representative positions include at least one of the following: electrode positions according to the 10-10 standard lead system contained in each part, or a predetermined proportion thereof; electrode positions according to the 10-10 standard lead system contained in each part and non-electrode positions between the electrode positions, or a predetermined proportion thereof; a predetermined number of positions in each part selected according to a predetermined method, and the predetermined method includes at least one of the following: randomly selecting a predetermined number of positions; evenly dividing each part into a predetermined number of grids and selecting the predetermined number of positions corresponding to the grids; selecting the predetermined number of positions other than the edge positions; selecting the positions of the projection points in each central part of the near-infrared irradiation unit.

[0113] In other embodiments of the present application, multiple light boards 5 can be directly arranged on the middle shell 2.

[0114] In an embodiment of the present application, as shown in FIG9 , six layers of lamp boards 5 are spaced apart on the lamp board fixing shell 9 , and the lamp boards 5 include at least one of the following arrangement modes.

[0115] Method 1: In the first layer of light panels 10 closest to the top of the head cap, there is a first gap between two adjacent light panels. The length of the narrowest position a of the first gap ranges from 23mm to 26mm, and the length of the widest position b of the first gap ranges from 57mm to 60mm. Furthermore, the length of the narrowest position a of the first gap ranges from 23.5mm to 25.5mm, and the length of the widest position b of the first gap ranges from 57.5mm to 59.5mm. Preferably, the length of the narrowest position a of the first gap is about 24mm, and the length of the widest position b of the first gap is about 59mm.

[0116] Method 2: In the second layer of light boards 11 adjacent to the first layer of light boards 10, a second gap is formed between adjacent light boards. The length of the second gap at its narrowest point ranges from 15mm to 18mm, and the length of the second gap at its widest point ranges from 41mm to 44mm. Furthermore, the length of the second gap at its narrowest point ranges from 16mm to 17.5mm, and the length of the second gap at its widest point ranges from 41mm to 43mm. Preferably, the length of the second gap at its narrowest point is approximately 16.7mm, and the length of the first gap at its widest point is approximately 42.5mm.

[0117] Method 3: In the third layer of light boards 12 located below the second layer of light boards 11, a third gap is defined between adjacent light boards. The length of the third gap at its narrowest point ranges from 13mm to 16mm, and the length of the third gap at its widest point ranges from 24mm to 27mm. Furthermore, the length of the third gap at its narrowest point ranges from 13.5mm to 15.5mm, and the length of the third gap at its widest point ranges from 24mm to 26mm. Preferably, the length of the third gap at its narrowest point is approximately 14.2mm, and the length of the third gap at its widest point is approximately 25.3mm.

[0118] Method 4: Located below the third layer of light boards 12 and arranged sequentially from top to bottom in the fourth layer of light boards 13, the fifth layer of light boards 14, and the sixth layer of light boards 15, there is a fourth gap between two adjacent light boards of the fourth layer of light boards 13. The length of the fourth gap at its narrowest position ranges from 12mm to 15mm, and the length of the fourth gap at its widest position ranges from 19mm to 22mm. Furthermore, the length of the fourth gap at its narrowest position ranges from 13.5mm to 14.5mm, and the length of the fourth gap at its widest position ranges from 19.5mm to 21.5mm. Preferably, the length of the fourth gap at its narrowest position is about 14mm, and the length of the fourth gap at its widest position is about 20.5mm.

[0119] In the fifth embodiment, a fifth gap is formed between adjacent light boards in the fifth layer 14. The length of the fifth gap at its narrowest point ranges from 12mm to 15mm, and the length of the fifth gap at its widest point ranges from 16mm to 19mm. Furthermore, the length of the fifth gap at its narrowest point ranges from 13mm to 14.5mm, and the length of the fifth gap at its widest point ranges from 16.5mm to 18.5mm. Preferably, the length of the fifth gap at its narrowest point is approximately 13.8mm, and the length of the fifth gap at its widest point is approximately 18mm.

[0120] Method 6: The sixth layer of light panels 15 is divided into two left and right sections, each section having three light panels. A sixth gap is defined between adjacent light panels. The length of the sixth gap at its narrowest point ranges from 11mm to 14mm, and the length of the sixth gap at its widest point ranges from 15mm to 18mm. Furthermore, the length of the sixth gap at its narrowest point ranges from 12mm to 14mm, and the length of the sixth gap at its widest point ranges from 15mm to 17mm. Preferably, the length of the sixth gap at its narrowest point is approximately 13mm, and the length of the sixth gap at its widest point is approximately 16.2mm.

[0121] The spacing setting of the above-mentioned light panels 5 and the setting between adjacent layers of the light panels 5 reduce the situation where the local temperature inside the head cap is too high due to the concentrated heat dissipation of the light panels 5, and save energy.

[0122] In a further optional embodiment of the present application, as shown in FIG9 , the gaps between adjacent lamp panels 5 in each layer have a narrowest position and a widest position, respectively. Furthermore, the width of the gaps between adjacent lamp panels 5 on each layer, from top to bottom, is greater than the width of the gaps between adjacent lamp panels 5 on the lower layer. This ensures that the lamp panels 5 can illuminate the entire space to achieve the desired phototherapy effect while reducing the probability of localized overheating within the phototherapy headgear due to concentrated heat dissipation from the lamp panels 5 due to the dense arrangement of the lamp panels 5. Furthermore, due to the structural design of the headgear for the phototherapy device, the inner diameter of the housing space gradually increases from top to bottom. Therefore, the spacing between the first and second layers of lamp panels 10, 11 is increased. This ensures uniform optical power density while preventing heat from the lamp panels 5 from accumulating within the headgear, facilitating cooling. To achieve uniform optical power density throughout the entire housing space, the optimal average optical power of the first and second layers of lamp panels 10, 11 can be between 75mw and 125mw, preferably approximately 100mw.

[0123] As shown in FIG9 , in some embodiments, the vertical spacing between the first layer of light boards 10 and the second layer of light boards 11 is 19 mm to 25 mm, preferably 19.5 mm to 24.5 mm. The vertical spacing between the second layer of light boards 11 and the third layer of light boards 12 is 14 mm to 21 mm, preferably 15 mm to 20 mm.

[0124] As shown in Figure 9, in some embodiments, the vertical spacing between the remaining two adjacent layers of light panels is 13mm to 19mm, preferably 14mm to 18mm. The vertical spacing between the adjacent layers of light panels can not only ensure that the entire brain area is illuminated, but also prevent the heat emitted by the light panels 5 from accumulating in the storage space.

[0125] Therefore, the arrangement of the light panel 5 can illuminate all areas of the patient's head, including the front upper part of the skull, the top of the skull, the left side of the skull and the right side of the skull, without affecting the normal progress of light therapy, and can also improve the comfort of the treatment process.

[0126] 10 , the light panels 5 are connected to the light panel fixing brackets 17, and the light panels 5 are detachably fixed to the light panel fixing housing 9 via the light panel fixing brackets 17. In some embodiments, the spacing between adjacent light panel fixing brackets 17 in each layer of light panel fixing brackets 17 is similar to or the same as the spacing between the corresponding adjacent light panels 5.

[0127] Returning to Figure 3, in some embodiments, the head cap is provided with an annular connecting portion 18, and the bottoms of the outer shell 1 and the middle shell 2 are respectively connected to the connecting portion 18. The connecting portion 18 is provided with a plurality of vents 16 that communicate with the lamp board accommodating cavity 4, and the area of ​​each vent 16 located at the rear end of the head cap is larger than the area of ​​each vent 16 located at the front end of the head cap. Furthermore, the vents 16 can be in the shape of long strips. This can increase the amount of wind entering the rear end of the head cap, so as to improve the cooling effect of the lamp board accommodating cavity 4 and balance the cooling effect at the back of the head and forehead of the head cap. Furthermore, this can also reduce the heat transfer from the lamp board accommodating cavity 4 to the cold air cavity 6, thereby helping to improve the cooling effect of the accommodating space.

[0128] In some embodiments, an exhaust port is provided on the top of the head cap, which is communicated with the light board accommodating cavity 4 and is used to extract hot air from the light board accommodating cavity 4.

[0129] In some embodiments, a total of 80 lamp boards 5 are distributed inside the head cap, the size of the near-infrared light outlet of each lamp board 5 is 28mm×28mm, with an allowable error of ±0.2mm, and the lamp beads are arranged in a 3×3 array.

[0130] The present application also provides a phototherapy device, which includes a trolley control device and a headgear according to any embodiment of the present application. The trolley control device includes a refrigeration device and an exhaust device. The refrigeration device is connected to the cold air inlet 8 and is used to pass cold air into the cold air cavity 6 through the cold air inlet 8. The exhaust device is connected to the exhaust port of the headgear. Through the cooperation of the trolley control device and the headgear, the patient is given phototherapy, and the wearer's comfort can be improved while the phototherapy is being performed.

[0131] We conducted a series of clinical trials using a light therapy device with this structure. As an example, the array of near-infrared irradiation units emits near-infrared light with a central wavelength of 810 nm, a 50% duty cycle, and a frequency of 10 Hz. However, this is merely an example. In some embodiments, near-infrared light can be emitted with a duty cycle of 30%-70%, a wavelength of 650-1100 nm, and a frequency within the alpha wave frequency range, the gamma wave frequency range, or a region adjacent to these two frequencies. This is not detailed here.

[0132] In some embodiments, the array of near-infrared irradiation units is specifically configured to irradiate at least 8260-42260 joules of energy to the subject's head within a continuous irradiation time of 5 minutes as a unit dose. 8260 joules of energy irradiation within 5 minutes is equivalent to continuously irradiating the skull with a time-averaged irradiation power of 27.5 W, assuming a skull surface area of ​​612.35 cm 2 To calculate, the spatiotemporal average optical power density is 45mW / cm 2 ; 42260 joules of energy irradiation in 5 minutes is equivalent to continuous irradiation of the skull with a time-averaged irradiation power of 140.8W. The surface area of ​​the skull is 612.35cm 2 To calculate, the spatiotemporal average optical power density is 230mW / cm 2 In clinical trials, the inventors found that for some patients with moderate and severe AD, continuous treatment for more than 10 minutes to half an hour without interruption is difficult. Some AD patients have severe cognitive impairment and are uncooperative. Some AD patients also frequently experience abnormalities in limb movement, such as muscle stiffness and flexion, muscle atrophy and weakness, and apraxia. Using a 5-minute unit dose means that each 5-minute exposure period has a certain degree of AD suppression effect.

[0133] For example, the required energy dose delivered to the subject's head within a single 1-hour session, such as three unit doses of at least 24,800 joules to 126,800 joules of energy, can be delivered as discrete or continuous effective unit doses. The cumulative dose delivered in this manner can achieve comparable AD suppression efficacy to a single session delivered continuously for 15 minutes. In practice, even if treatment is interrupted due to patient-specific reasons or operational failure, the operator only needs to ensure that the cumulative irradiation time within the single session meets the required duration. There is no need to restart the phototherapy device, reset the current irradiation dose, or impose a fixed rest period for irradiation. Specifically, if the subject is highly compliant and treatment is proceeding smoothly, irradiation can continue for 15 minutes. If the subject's compliance is low or treatment is not proceeding smoothly, such as requiring a bathroom break after 6 minutes, treatment can be temporarily interrupted and resumed upon their return. The interruption time can be flexibly adjusted based on the subject's needs, as long as all irradiation times are completed within the 1-hour period. This significantly reduces the operational difficulty of light therapy for AD patients with severe cognitive impairment or motor abnormalities that lead to non-cooperation, as well as for groups with varying degrees of AD severity (such as nursing home populations across age groups), and even for caregivers who lack experience in caring for AD patients.

[0134] In some embodiments, the array of the near-infrared irradiation unit is specifically configured to irradiate at least 24,800 joules to 1,014,100 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 27.5W, and an upper limit of 2 hours of irradiation at a time-averaged irradiation power of 140.8W. The inventors have found that using the light therapy equipment of the present application, the single-day cumulative dose can be adjusted over a large span according to the adaptability of the subject. Specifically, if the subject has a high degree of cooperation with light therapy and a good individual response, the array of the near-infrared irradiation unit is specifically configured to implement a single-period cumulative dose by continuously irradiating for more than 30 minutes in a single period of 1 hour, and up to 4 times in a single day to provide an accelerated single-day cumulative dose. The accelerated single-day cumulative dose is equivalent to the amount of a small single-day cumulative dose for several days. If a subject needs to interrupt treatment for a few days due to specific circumstances, an accelerated single-day cumulative dose can be administered first, increasing the flexibility and convenience of light therapy. In addition, although the mechanism of action is not yet clear, the improvement in cognitive performance after the accelerated single-day cumulative dose was even better than the effect of the same cumulative dose administered over several days.

[0135] In some embodiments, the array of near-infrared irradiation units is specifically configured to provide a cumulative dose of at least 124,000 joules (27.5 W - 15 minutes - 5 times) to 7,099,000 (230 mW / cm 2 -2 hours per day for 7 days) joules of energy are irradiated to the subject's head as a weekly cumulative dose. The single-session cumulative dose can be divided into time periods and implemented 1 time, 2 times, 3 times, 4 times, 5 times, 6 times, 7 times or 8 times on each day of the irradiation per week.

[0136] Specifically, the array of the near-infrared irradiation units is specifically configured to implement more than 8 times the weekly cumulative dose within 8 weeks, preferably more than 16 times the weekly cumulative dose within 16 weeks, as the cumulative dose for the course of treatment.

[0137] In some embodiments, the treatment interruption time between two treatment courses does not exceed half of the treatment course duration to minimize the deterioration of AD pathological conditions caused by interrupted treatment.

[0138] The applicant conducted a clinical experiment on a test group (i.e., a treatment group) using the phototherapy device shown in Figures 1-3. The spatiotemporal average optical power density of the phototherapy device at various locations on the reference head model of the subject's head is shown in Table 1. The phototherapy device in this clinical experiment, when the subject's head was in place within the accommodation space formed by the support mechanism, formed an irradiation spatial range covering the upper front 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. The time-averaged total irradiation power acting on the skull of the subject's head reached more than 31W, approximately 32W-48W, and the spatiotemporal average optical power density did not exceed 230mW / cm 2 .

[0139] Table 1 Spatiotemporal average optical power density of the light therapy device at various locations on the reference head model

[0140] The applicant conducted a clinical experiment on the experimental group (ie, the treatment group) using the light therapy device with the operating parameters shown in Table 2.

[0141] Table 2 Operating parameters of light therapy equipment

[0142] The inclusion criteria for this clinical trial are as follows: (1) meeting the core criteria for probable Alzheimer's disease (AD) as defined by the National Institute on Aging-Alzheimer's Association (NIA-AA); (2) brain MRI examination results (within 6 months) supporting a possible diagnosis of AD; (3) aged 50-85 years, regardless of gender; (4) MMSE score <26 points, and able to cooperate in completing the scale assessment; (5) patients are not taking medication. If they are taking psychiatric or cognitive improvement drugs, the dosage must be stable for at least 12 weeks before the trial and remain unchanged during treatment.

[0143] Exclusion criteria: (1) presence of contraindications to MRI, such as metal implants or claustrophobia; (2) other types of dementia or other psychiatric or neurological 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 that makes participation in this study unsuitable.

[0144] Based on 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 810nm, frequency 10Hz. Each participant received 30 minutes of treatment daily, 6 days a week, for 4 months. The sham treatment group followed the same protocol as the near-infrared light treatment group, but used a sham head cap. The light emitted by the sham device was visually identical to the near-infrared device, and the treatment produced a similar sound and warming sensation on the scalp as the near-infrared device. However, the light power was very weak and was largely absorbed by tissue, failing to stimulate brain tissue (see Figure 11).

[0145] The scale assessment was conducted at the 2nd and 4th months of the treatment period, and at 2 and 4 months (6th and 8th months) after the end of treatment, as shown in Figure 11. As can be seen, the clinical trial of this application set the interval for each scale statistical analysis to 2 months instead of 1 month, which weakened the learning effect of the subjects and made the scale scoring more objective and accurate.

[0146] Assessors, participants, and their caregivers remained blinded to treatment assignment throughout the study until its completion. Treatment assignment was not discussed throughout the study. Participants believed they were receiving genuine near-infrared therapy.

[0147] 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 assessment. Among them, 1 patient only completed the MMSE scale assessment in the scale assessment, and did not complete the ADAS-cog scale. The ADAS-Cog scale consists of 12 items, covering memory, orientation, language, application, attention, etc. It can assess the severity of AD cognitive symptoms and treatment changes. It is often used to evaluate the efficacy of mild to moderate AD (usually an improvement of 4 points is used as the clinical criterion for drug efficacy). 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 the MMSE have found that in professional institutions such as memory clinics or in community hospitals, the sensitivity and specificity of the MMSE in distinguishing normal elderly people from dementia are both over 80%, which has good value in screening dementia.

[0148] To investigate the long-term efficacy of near-infrared light therapy for AD patients, a follow-up visit was conducted after the treatment. A total of 14 subjects completed the 8-month follow-up visit (i.e., 4 months after treatment, 8 in the treatment group and 6 in the control group).

[0149] As shown in Figures 12(a) and 12(b), two months after light therapy, the ADAS-cog scores of the treatment group decreased by an average of 1.11 points from baseline. Four months after treatment, the decrease continued at a steeper rate, reaching an average decrease of 6.04 points from baseline (p = 0.034 < 0.05), significantly superior to the control group's scores. Within two months after treatment, ADAS-cog scores in the treatment group fluctuated less, remaining at an average decrease of 5.59 points from baseline at two months after treatment (p = 0.009 < 0.05). Upon follow-up two months after treatment, ADAS-cog scores in the treatment group even began to decline, decreasing by an average of 8.25 points from baseline at four months after treatment (p = 0.008 < 0.05). Judging from the ADAS-cog scale scores, the phototherapy device of the present application has achieved beneficial effects that have never appeared in papers and related literature on other existing phototherapy devices: within the four months of phototherapy, the ADAS-cog scale scores decreased at a larger slope after the second month compared with the previous two months; two follow-up visits every two months after the end of phototherapy found that the biochemical reactions caused by the irradiation energy of the near-infrared light delivered to the subject's head continued to trigger an inhibitory effect after the end of phototherapy, not only maintaining the inhibitory effect on AD to a certain extent, but even continuously promoting the inhibitory effect on AD, and there was no deterioration of the ADAS-cog scale score.

[0150] As shown in Figures 13(a) and 13(b), after two months of light therapy, the MMSE scores of the treatment group increased by an average of 0.67 points from baseline. During the following two months of light therapy, MMSE scores continued to improve at a steeper rate, reaching an average of 2.78 points from baseline by four months, significantly superior to the control group (P = 0.025 < 0.05). Both ADAS-cog and MMSE scores showed similar improvements during the first two months and the last two months of light therapy, with the improvement continuing at a steeper rate during the latter two months. Furthermore, similar to the continued improvement in ADAS-cog scores after light therapy, MMSE scores continued to rise two months after light therapy, even after light therapy was discontinued, maintaining a similar upward slope to that during treatment. By two months after light therapy, the average improvement from baseline had reached 3.89 points (P = 0.004 < 0.05). Four months after the end of light therapy, the MMSE scale scores of the treatment group remained comparable to those obtained four months after light therapy, with no regression. In other words, judging by the MMSE scale scores, the biochemical reactions caused by the irradiation energy of the near-infrared light delivered to the subjects' heads continued to trigger an inhibitory effect after the end of light therapy, not only maintaining a certain degree of inhibitory effect on AD, but even continuing to promote this inhibitory effect, without any regression of the ADAS-cog scale scores.

[0151] Combined with the results of follow-up visits during and after the light therapy, the optimized "light charging" and continuous benefit process of the light therapy device of the present application mentioned above were also confirmed: the "light charging capacity" of the subject's brain was larger, the "light charging depth" was deeper, and the "light charging speed" was faster. The scale scores improved significantly in the first 2 months and the last 2 months of the light therapy, and occurred at a stable slope without stagnation; the subsequent "endurance" ability and continuous benefit were better, and the effect of 2 months of light therapy was maintained for at least 2 months after the end of light therapy, and even for 4 months after the end of light therapy. Moreover, the biochemical reaction caused by "light charging" continued to trigger an inhibitory effect after the end of light therapy, and continued to promote the inhibitory effect on AD without deterioration and callback.

[0152] Furthermore, four months after near-infrared light therapy, resting-state functional MRI results in the treatment group showed increased ALFF in multiple brain regions across the frontal, occipital, and temporal lobes (P<0.05), indicating increased neuronal excitability and spontaneous activity, providing neuroimaging evidence for improved cognitive function. No adverse events related to the trial device were observed in this trial.

[0153] Although phototherapy lasted for 4 months in this clinical trial, it showed the characteristics of deep regulation, sustained benefits, and even cumulative benefits. If it is used for a longer period of time, such as 6 months, 8 months, 10 months,... more than 1 year, or even year-round, the benefits are expected to continue to increase, reflecting a more significant disease-modifying effect.

[0154] The above description is intended to be illustrative rather than restrictive, and those skilled in the art may make changes, modifications, substitutions, and variations to the above embodiments within the scope of the present disclosure. Furthermore, the above examples (or one or more of them) may be used in combination with each other, and it is contemplated that these embodiments may be combined with each other in various combinations or permutations.

Claims

1. A light therapy device for inhibiting or preventing Alzheimer's disease, characterized in that: include: A carrying mechanism, the carrying mechanism being configured to form a receiving space for the subject's head and to carry an array of near-infrared irradiation units; as well as The array of near-infrared irradiation units is constructed as follows: near-infrared light is emitted into the accommodation space, and when the subject's head is in place in the accommodation space, an irradiation space range is formed to cover at least the front upper part of the skull, the top of the skull, the left side of the skull and the right side of the skull on the surface of the skull of the subject's head, and the time-averaged total irradiation power acting on the skull of the subject's head reaches 27.5 W or more, 31 W or more, or 40 W or more, or 60 W or more, or 70 W or more, and the time-space average light power density irradiated to each part does not exceed 230 mW / cm 2 .

2. The light therapy device according to claim 1, characterized in that The subject head includes the head of the patient being treated, or a reference head mold of a group of patients being treated. The head of the patient being treated or the reference head mold of a group of patients being treated has the following parameters: head width is 140-166 mm, head length is 170-196 mm, and head circumference is 525-583 mm.

3. The light therapy device according to claim 1, characterized in that The front upper part of the skull, the top of the skull, the left side of the skull and the right side of the skull, together with the back of the skull, are within the total area enclosed by the total boundary line, and the total boundary line runs from the glabella of the subject's head through the preauricular points on both sides, and goes around backwards through the occipital protuberance and merges between the electrode positions O1, OZ and O2 of the 10-10 international standard lead system, and the front upper part of the skull, the top of the skull, together with the left side of the skull and the right side of the skull are within the first area divided from the total area by the fifth boundary line, and occupy more than 60%, or more than 70%, or more than 80% of the surface area of ​​the first area; According to the 10-10 standard lead system, the fifth boundary line passes sequentially 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.

4. The light therapy device according to claim 3, characterized in that The front upper part of the skull is within a first sub-region surrounded by the first boundary line and the total boundary line, and according to the 10-10 standard lead system, the first boundary line passes through the following electrode positions in sequence: 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, and the front upper part of the skull occupies more than 60%, or more than 70%, or more than 80% of the surface area of ​​the first sub-region; and / or The top of the skull is within a second sub-region surrounded by a second boundary line, and according to the 10-10 standard lead system, the second boundary line passes through the following electrode positions in sequence: 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, and the top of the skull occupies more than 60%, or more than 70%, or more than 80% of the surface area of ​​the second sub-region; and / or The left side of the skull is in a third sub-region surrounded by the third boundary line and the overall boundary line, and the right side of the skull is in a fourth sub-region surrounded by the fourth boundary line and the overall boundary line. According to the 10-10 standard lead system, the third boundary line passes through the following electrode positions in sequence: 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 fourth boundary line passes through the following electrode positions in sequence: 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 left side of the skull occupies more than 60%, or more than 70%, or more than 80% of the surface area of ​​the third sub-region, and the right side of the skull occupies more than 50% of the surface area of ​​the third sub-region. The surface area of ​​the fourth sub-region is more than 60%, or more than 70%, or more than 80%.

5. The light therapy device according to any one of claims 1 to 4, characterized in that According to the 10-10 standard lead system, The upper front skull portion includes electrode positions FP2, FPZ, FP1, AF3, AF4, AF7, AF8, AFZ, FZ, F1, F2, F3, F4, F5, F6, F7, F8, FC1, FC2, FC3, FC4, FCZ; and / or The top of the skull includes electrode locations CZ, C1, C2, C3, C4, CPZ, CP1, CP2, CP3, CP4, PZ, P1, P2, P3, P4; and / or The left side of the skull includes electrode positions FT7, FC5, T7, C5, TP7, CP5, P7, and P5, and the right side of the skull includes electrode positions FT8, FC6, T8, C6, TP8, CP6, P8, and P6.

6. The light therapy device according to any one of claims 1 to 4, characterized in that According to the 10-10 standard lead system, The upper front part of the skull comprises electrode positions AFZ, FZ, F1, F2, FP1, FP2; and / or The top of the skull includes electrode locations CZ, C1, C2 and CPZ; and / or The left side of the skull includes electrode positions FT7, FC5, T7, C5, or TP7, CP5, P7 or P5, and the right side of the skull includes electrode positions FT8, FC6, T8, C6, or TP8, CP6, P8, P6.

7. The light therapy device according to any one of claims 1 to 4, characterized in that According to the 10-10 standard lead system, The upper front skull portion includes electrode locations FP2, FPZ, FP1, AF3, AF4, AF7, AF8, AFZ, FZ, F1, F2, F3, F4, F5, F6, F7, FC5, F8, FC1, FC2, FC3, FC4, FCZ, FC6, CZ, C1, C2; and / or The top of the skull includes electrode locations C5, C3, C4, C6, CPZ, CP1, CP2, CP3, CP4, CP5, CP6, PZ, P1, P2, P3, P4; and / or The left side of the skull includes electrode positions FT7, T7, TP7, and P7, and the right side of the skull includes electrode positions FT8, T8, TP8, and P8.

8. The light therapy device according to any one of claims 1 to 4, characterized in that According to the 10-10 standard lead system, The upper front skull portion includes electrode locations FP2, FPZ, FP1, AF3, AF4, AF7, AF8, AFZ, FZ, F1, F2, F3, F4, F5, F6, FC1, FC2, FC3, FC4, FC5, FC6, FCZ, CZ, C1, C2; and / or The top of the skull includes electrode locations C3, C4, C5, C6, CPZ, CP1, CP2, CP3, CP4, CP5, CP6, PZ, P1, P2, P3, P4; and / or The left side of the skull includes electrode positions F7, FT7, T7, TP7, and P5, and the right side of the skull includes electrode positions F8, FT8, T8, TP8, and P6.

9. The light therapy device according to claim 3, characterized in that The irradiated spatial range also covers the posterior skull, which is within a fifth sub-region divided from the overall region by the fifth boundary line, and the fifth sub-region is located below the first region.

10. The light therapy device according to any one of claims 1 to 4, characterized in that The irradiated spatial range also covers the posterior skull, which includes electrode positions PO7, PO5, PO3, POZ, PO4, P06, PO8, O1, OZ and O2.

11. The light therapy device according to any one of claims 1 to 4, characterized in that The irradiated spatial range also covers the posterior skull, which at least includes the occipital region above the external occipital protuberance.

12. The light therapy device according to any one of claims 1 to 4, characterized in that The temporal and spatial average optical power density irradiated to the top of the skull and the upper front of the skull is 55 mW / cm 2 The time-space average optical power density irradiated to the left and right sides of the skull is 35 mW / cm 2 above.

13. The light therapy device according to any one of claims 1 to 4, characterized in that The irradiated spatial range also covers the back of the skull, and the spatiotemporal average optical power density irradiated to the back of the skull is 13 mW / cm 2 above.

14. The light therapy device according to any one of claims 1 to 4, characterized in that When the array of the near-infrared irradiation units is distributed on a spatial curved surface covered with a predetermined gap on the subject's head, the spatiotemporal average light power density irradiated to the top of the skull and the upper front of the skull is higher than the spatiotemporal average light power density irradiated to the left side of the skull and the right side of the skull.

15. The light therapy device according to any one of claims 1 to 4, characterized in that The irradiation spatial range also covers the back of the skull. The spatiotemporal average light power density irradiated to the top and upper front of the skull, as well as the spatiotemporal average light power density irradiated to the left and right sides of the skull, are all higher than the spatiotemporal average light power density irradiated to the back of the skull.

16. The light therapy device according to any one of claims 1 to 4, characterized in that The spatiotemporal average optical power density irradiated to each part is determined according to the temporal average optical power density of a representative position of each part, wherein the representative position includes at least one of the following: The locations of electrodes contained in each section according to the 10-10 standard lead system, or a predetermined ratio thereof; Electrode positions according to the 10-10 standard lead system included in each section and non-electrode positions between said electrode positions, or a predetermined ratio thereof; A predetermined number of positions in each part are selected in a predetermined manner, and the predetermined manner includes at least one of the following: randomly selecting a predetermined number of positions; evenly dividing each part into a predetermined number of grids and selecting the predetermined number of positions corresponding to the grids; selecting the predetermined number of positions except the edge positions; selecting the positions of the projection points in each central part of the near-infrared irradiation unit.

17. The light therapy device according to any one of claims 1 to 4, characterized in that The supporting mechanism includes a cover body arranged in the air, the cover body is formed to form a cavity, and when the subject's head is in place in the accommodating space, the size of the cavity is suitable for accommodating the subject's head in a loose manner without applying pressure to the subject's head, and each near-infrared irradiation unit in the first group of near-infrared irradiation units has a preset emission angle, and has a preset spacing and height difference configuration, so that a plurality of convergence areas are formed above the top of the skull and the upper front of the skull, and the near-infrared light is converged at each convergence area.

18. The light therapy device according to claim 17, characterized in that The corresponding near-infrared irradiation units above the top of the skull and the front upper part of the skull are arranged along the arched curved surface, and when the subject's head is in place in the accommodation space, the first average spacing between the top of the skull and the front upper part of the skull and the corresponding near-infrared irradiation units is greater than the predetermined average spacing, so that the spatiotemporal average optical power density at the convergence area above the top of the skull and the front upper part of the skull is 58 mW / cm 2 above.

19. The light therapy device according to any one of claims 1 to 4, characterized in that The supporting mechanism comprises a cover body arranged in the air, the cover body is formed to form a cavity, the cover body carries at least three groups of near-infrared irradiation units at different heights, and each group of near-infrared irradiation units is arranged at intervals in the circumferential direction at a corresponding height.

20. The light therapy device according to claim 19, characterized in that The cavity formed by the mask is bell-shaped. When the subject's head is in place in the accommodating space, the lower part of the mask is located at the tragus or its periphery on both sides, at a predetermined distance above or below the external occipital protuberance on the rear side, and above the brow bone on the front side.

21. The light therapy device according to claim 19, characterized in that The cover body includes a light-transmitting protection portion, which forms a front upper portion, a top portion, a rear portion, a left portion and a right portion, and surrounds the cavity; The near infrared light emitted from the top, front upper part, rear part, left side and right side of the light-transmitting protective part forms an irradiated curved surface without holes on the surface of the skull of the subject's head.

22. The light therapy device of claim 19, wherein: The cover body includes a light-transmitting protection part, which forms a front upper part, a top part, a rear part, a left part and a right part, and surrounds the cavity. The light-transmitting protection part is an integrated shell, and each inner wall of the light-transmitting protection part emits near-infrared light.

23. The light therapy device according to any one of claims 1 to 4, characterized in that Each near-infrared irradiation unit includes 4-9 near-infrared LEDs, the time-averaged light power of each near-infrared LED is 80mw-100mw, and the irradiation area of ​​each near-infrared irradiation unit is 5-9cm 2 .

24. The light therapy device according to any one of claims 1 to 4, characterized in that The phototherapy device also includes a cooling mechanism, which is configured to ensure that the temperature of the air in the space adjacent to but not in contact with the subject's head does not exceed 41°C when the time-averaged total irradiation power irradiated to the subject's head reaches 27.5-120W and the single continuous irradiation duration reaches 30 minutes.

25. The light therapy device according to any one of claims 1 to 4, characterized in that The array of near-infrared irradiation units is specifically configured to irradiate at least 8260-42260 joules of energy to the subject's head as a unit dose within a continuous irradiation time of 5 minutes.

26. A light therapy device according to any one of claims 1 to 4, characterized in that The array of near-infrared irradiation units is specifically configured to irradiate at least 24,800 joules to 126,800 joules of energy to the subject's head in a single period of 1 hour in a discrete or continuous effective unit dose as a single-period cumulative dose.

27. A light therapy device according to any one of claims 1 to 4, characterized in that The array of near-infrared irradiation units is specifically configured to irradiate at least 24,800 joules to 1,014,100 joules of energy to the subject's head in a single day as a single-day cumulative dose.

28. The light therapy device according to claim 27, characterized in that The array of near-infrared irradiation units is specifically configured to provide an accelerated single-day cumulative dose by continuously irradiating for more than 30 minutes in a single period of 1 hour, and up to 4 times in a single day.

29. The light therapy device of claim 26, wherein: The array of the near-infrared irradiation units is specifically configured as follows: at least 124,000 joules to 7,099,000 joules of energy are irradiated to the subject's head in separate single-period cumulative doses within a week as a weekly cumulative dose, and the single-period cumulative dose can be implemented in time periods 1, 2, 3, 4, 5, 6, 7 or 8 times on each day of the irradiation each week.

30. The light therapy device of claim 29, wherein: The array of the near-infrared irradiation units is specifically configured to implement more than 8 times of the weekly cumulative dose within 8 weeks, preferably more than 16 times of the weekly cumulative dose within 16 weeks, as the cumulative dose for the course of treatment.

31. The light therapy device of claim 30, wherein: The interruption of treatment between two courses did not exceed half of the course duration.

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