Phototherapy device for improving and treating mild cognitive impairment caused by Alzheimer's disease

Abstract

This invention provides a phototherapy device for improving and treating mild cognitive impairment caused by Alzheimer's disease. [Solution] The device includes a head-worn body worn on the user's head, and a light-emitting section positioned on the head-worn body to irradiate light onto the frontal lobe, with a plurality of laser diodes arranged on a substrate. The laser diodes are composed of a mixed-type LD module 2a', 2a'' which has a wavelength range of 800nm ​​to 1100nm and an average output range of 70mW to 340mW. The mixed-type LD module may include a plurality of first laser diodes 22a configured with a wavelength of 808±10nm and an average light output in the range of 277mW±20%, and a plurality of second laser diodes 22b configured with a wavelength of 808±10nm and an average light output in the range of 100mW±20%.

Description

[Technical Field]

[0001] The present invention relates to a phototherapy device for improving and treating mild cognitive impairment caused by Alzheimer's disease, and more specifically, to a phototherapy device for improving and treating mild cognitive impairment caused by Alzheimer's disease that uses near-infrared laser light to improve and treat the cognitive function of patients with mild cognitive impairment caused by Alzheimer's disease. [Background technology]

[0002] Generally, it has been proven that irradiating human tissue with light in the red and near-infrared regions can heal wounds, inflammation, and edema in living tissue, and reduce peripheral nerve damage, among other beneficial effects. Low-level laser therapy (LLLT), which utilizes this effect, is attracting attention.

[0003] Low-level laser therapy (LLLT) applied to the human body has the drawbacks of a relatively slow onset of healing and a long treatment period, but it is extremely safe, has no side effects, and is economical. Therefore, it is attracting much attention as a treatment method particularly suitable for home treatment by non-specialists. (See Hamblin 2016, Cassano 2018, Iosifescu 2022)

[0004] Low-level laser therapy (LLLT) involves irradiating living tissue with light in the red near-infrared (NIR) region. It has been confirmed that this increases blood flow and significantly raises ATP levels in the treated area, resulting in increased capillary formation, promotion of DNA synthesis, increased oxygen content in the blood, promotion of collagen production, increased lymphatic flow, promotion of tissue granulation, and activation of phagocytosis.

[0005] Therefore, by utilizing this effect, it is possible to achieve 1) activation of cell tissue metabolism, 2) promotion of healing of damaged cell tissue, 3) regeneration and prevention of degeneration of cell tissue due to aging and disease, and 4) improvement of the immune function of cell tissue. As a result, it is expected to have a wide range of applications in the treatment of various diseases, as well as in the fields of rehabilitation and public health.

[0006] It is known that the photobiological effect of near-infrared (NIR) energy is that when light in this wavelength range enters biological tissue, its photon energy is absorbed by the cell membrane and cytochrome C oxidase (CCO) and porphyrins inside mitochondria, generating singlet oxygen, creating an electrical potential gradient between the cell membrane and the mitochondrial membrane, increasing the permeability of the cell membrane, and raising the level of ATP (Adenosine Triphosphate).

[0007] A new non-invasive neuromodulation therapy technique called transcranial photo-bio-modulation (t-PBM) has been proposed, utilizing these near-infrared (NIR) characteristics. According to this technique, near-infrared laser (NIR) light is injected into the cerebral cortex to stimulate and activate dying cells and tissues, ultimately leading to healing. In particular, near-infrared lasers (NIR) of specific wavelengths are known to penetrate the cerebral cortex strongly. The light that penetrates the cranial cavity affects the brain by increasing adenosine triphosphate (ATP) production in mitochondria and increasing regional cerebral blood flow.

[0008] Based on these physiological effects, irradiating the frontal lobe area inside the skull with laser light in the near-infrared wavelength range can improve or treat various neurological disorders such as early-stage Alzheimer's disease, dementia, cognitive impairment, and Parkinson's disease.

[0009] In healthy brain tissue cells, mitochondria absorb oxygen and produce adenosine triphosphate (ATP). Cells whose blood flow is blocked due to conditions such as cerebral infarction die due to lack of oxygen. However, it is known that when near-infrared laser (NIR) light is irradiated, mitochondria absorb light energy, generating a membrane potential, which in turn produces ATP and revives damaged nerve cells.

[0010] The biggest obstacle to applying low-level laser therapy (LLLT) technology to the treatment of brain tissue-related diseases is that the brain parenchyma is protected by the scalp, skull, dura mater, and arachnoid membrane, making it impossible to directly deliver light energy to it.

[0011] Therefore, transcranial low-level laser therapy (TLT) or transcranial near-infrared laser therapy (NILT), which involves placing the light source outside the scalp and projecting light energy into the cerebral parenchyma via the skull, has been proposed.

[0012] This method allows for the treatment of brain disorders without opening the skull, making it essentially a non-invasive treatment. It is characterized by minimal mental and physical burden on the patient and is extremely economical.

[0013] Furthermore, as transcranial photobiomodulation (t-PBM) therapeutic technologies utilizing near-infrared (NIR) characteristics, technologies such as "Automated Personalized Brain Modulation System and Method Using Photobiomodulation" (Korean Registered Patent No. 10-2565489) and "Transcranial Light Irradiation Device Using Light-Emitting Diodes" (Korean Registered Patent No. 10-2413975) have been proposed.

[0014] However, transcranial photobiomodulation (t-PBM) therapy techniques utilizing near-infrared (NIR) characteristics have not been substantially validated, and the technology for specific applications is insufficient. In reality, it is being used vaguely without verifying the specific wavelength, power output, irradiation distance, and irradiation time of the near-infrared laser diode, which leads to problems in achieving appropriate therapeutic effects.

[0015] Furthermore, according to the conventional Korean Registered Patent No. 10-2565489 and Korean Registered Patent No. 10-2413975, the transcranial photobiomodulation (t-PBM) therapy technology involves arranging multiple laser diodes in the frontal lobe, parietal lobe, and bilateral temporal lobe positions within the skull to enhance therapeutic effects. However, increasing the number of laser diodes indiscriminately can lead to excessive heat generation, causing skin damage and, in severe cases, burns. In addition, there are limitations associated with the installation of an excessive number of laser diodes, such as increased battery capacity, increased component costs due to the addition and increase in capacity of other components, and increased power consumption. [Prior art documents] [Patent Documents]

[0016] [Patent Document 1] Korean Registered Patent No. 10-2565489 "Automated Personalized Brain Regulation System and Method Using Photo-Bio-Modification" [Patent Document 2] Korean Registered Patent No. 10-2413975 "Light-emitting diode-based light irradiation device for the light-emitting skull" [Overview of the project] [Problems that the invention aims to solve]

[0017] The present invention has been proposed in view of the foregoing content, and an object of the present invention is to provide a phototherapeutic device for improving and treating mild cognitive impairment caused by Alzheimer's disease, which is capable of improving or treating early Alzheimer's disease and memory impairment mild cognitive impairment by a non-invasive method, wherein each laser beam in a specific near-infrared wavelength region is irradiated to the position of the prefrontal cortex to penetrate into the cerebral cortex and stimulate the cerebral cortex.

[0018] Another object of the present invention is to provide a phototherapeutic device for improving and treating mild cognitive impairment caused by Alzheimer's disease, which can prevent skin damage caused by heat generation of laser diodes in advance in the process of respectively irradiating each laser beam in a specific near-infrared wavelength region to the position of the prefrontal cortex, minimize the power supply capacity and the arrangement number of laser diodes, thereby improving safety and durability in use, and reducing manufacturing costs and maintenance costs. [Means for Solving the Problem]

[0019] In order to achieve the above object, a phototherapeutic device for improving and treating mild cognitive impairment caused by Alzheimer's disease according to the present invention comprises: a head-worn main body that is worn on the head of a user; and a light irradiation unit arranged on the head-worn main body to irradiate light to the position of the prefrontal lobe, wherein a plurality of laser diodes are arranged on a substrate, and the laser diodes are composed of a mixed LD module provided with a plurality of laser diodes having a wavelength band in the range of 800 nm to 1100 nm and an average output in the range of 70 mW to 340 mW.

[0020] The mixed LD module may comprise a plurality of first laser diodes each having a wavelength of 808±10 nm and an average light output in the range of 277 mW±20%, and a plurality of second laser diodes each having a wavelength of 808±10 nm and an average light output in the range of 100 mW±20%.

[0021] Said first laser diode and said second laser diode can be arranged such that the distance from the scalp at the prefrontal lobe position is within a range of 20 mm ± 20% so that the amount of light energy that exhibits an optimal light irradiation effect while preventing thermal damage to the scalp does not exceed 4400 [Joules / cm 2 .

[0022] Said mixed LD module may be configured to comprise: a left mixed LD module comprising a main light output unit in which a plurality of said first laser diodes are arranged close to each other so as to irradiate light to the left dorsolateral prefrontal cortex, and an auxiliary light output unit in which a plurality of said second laser diodes are arranged around said main light output unit; and a right mixed LD module spaced apart from said left mixed LD module, comprising a main light output unit in which a plurality of said first laser diodes are arranged close to each other so as to irradiate light to the right dorsolateral prefrontal cortex, and an auxiliary light output unit in which a plurality of said second laser diodes are arranged around said main light output unit.

[0023] Each of said left mixed LD module and said right mixed LD module can form a diffusion area of light diffused on the scalp of 12cm 2 ± 20%, wherein nine said first laser diodes are arranged at equal intervals in said main light output unit so as to uniformly irradiate light onto a square region on the scalp at the left prefrontal cortex position and a square region on the scalp at the right prefrontal cortex position, and eight said second laser diodes are arranged in a "U" shape in said auxiliary light output unit so as to uniformly irradiate light from the lower, left and right outer contours of said square region.

[0024] Said left mixed LD module and said right mixed LD module can be arranged such that their narrow angles form an obtuse angle to improve the light penetration characteristic into the cerebral parenchyma, and can be configured such that said first laser diode and said second laser diode face the prefrontal cortex.

[0025] The first laser diode has a wavelength of 808 nm and an average light output of 277 mW, and the second laser diode has a wavelength of 808 nm and an average light output of 100 mW. The first and second laser diodes can be arranged so that they are 20 mm away from the scalp at the location of the prefrontal cortex.

[0026] The first and second laser diodes are output at 42 Hz with a duty cycle of 33% under the control of the control unit, and the amount of light energy is 4390 joules / cm². 2 It can be configured to be controlled to be within a smaller range than ].

[0027] The main optical output section can be composed of nine first laser diodes arranged at equal intervals.

[0028] The auxiliary light output unit is the 12cm 2 The second laser diode can be configured such that non-illuminated areas are formed at the four corners of the ±20% square region, with two on the bottom and three each on the left and right sides.

[0029] The head-worn body can be configured with an LD mounting groove into which the mixed-type LD module is mounted, recessed so that the distance between the first laser diode and the second laser diode and the scalp at the prefrontal cortex is within 20 mm ± 20%.

[0030] The LD mounting groove can consist of a left-side LD mounting groove where the left-side mixed-type LD module is positioned, and a right-side LD mounting groove where the right-side mixed-type LD module is positioned.

[0031] Preferably, the narrow angles of the left-side mixed LD module and the right-side mixed LD module can be formed with an angle inclination within the range of 151° ± 5%.

[0032] The head-worn body may include an inner head case in which the LD mounting groove is formed and the head is seated; an outer head case provided outside the inner head case; a left seating guide portion and a right seating guide portion formed on the left and right sides, respectively, so as to sit on the left and right sides of the head; a first position-holding device that sits on the user's forehead so as to orient the LD mounting groove in the prefrontal cortex; and a second position-holding device that sits on the back of the user's head so as to orient the LD mounting groove in the prefrontal cortex.

[0033] The left LD mounting groove and the right LD mounting groove can be recessed such that the distance between the forehead seating surface of the first position holding device and the surface of the inner head case, and the recess depth of the left LD mounting groove and the right LD mounting groove are within a range of 20 mm ± 20%. [Effects of the Invention]

[0034] According to the phototherapy device for improving and treating mild cognitive impairment caused by Alzheimer's disease according to the present invention, as can be seen from clinical trial results, by implementing transcranial photobiomodulation (t-PBM) therapy technology that irradiates both sides (left / right) of the prefrontal cortex with low-level near-infrared laser light having a specific wavelength and output, it is possible to improve, treat, and prevent cognitive function in patients with mild cognitive impairment and mild Alzheimer's disease. Furthermore, it is expected to have beneficial effects on traumatic diseases (stroke, brain injury, whole-cerebral ischemia) and mental disorders (depression, anxiety, post-traumatic stress disorder).

[0035] The phototherapy device for improving and treating mild cognitive impairment caused by Alzheimer's disease according to the present invention uses low-level laser light to irradiate with a limited maximum energy amount, and can be used safely and accurately without side effects using interlocks and sensing sensors. In particular, the light irradiation section is configured with a combination of multiple low-level laser diodes with a wavelength of 808 [nm], an average output of 277 [mW] and 100 [mW], which reduces manufacturing costs, prevents skin damage due to laser diode overheating, and minimizes the power supply capacity and the number of laser diodes, thereby improving safety and durability in use, and reducing manufacturing and maintenance costs. [Brief explanation of the drawing]

[0036] [Figure 1] This is a perspective view showing a phototherapy device for improving and treating mild cognitive impairment caused by Alzheimer's disease, according to one embodiment of the present invention. [Figure 2] This is a perspective view showing the inside of a phototherapy device for improving and treating mild cognitive impairment caused by Alzheimer's disease, according to one embodiment of the present invention. [Figure 3] This is a separated perspective view showing a phototherapy device for improving and treating mild cognitive impairment caused by Alzheimer's disease according to one embodiment of the present invention. [Figure 4] This is a separated perspective view illustrating the light irradiation section of a phototherapy device for improving and treating mild cognitive impairment caused by Alzheimer's disease, according to one embodiment of the present invention. [Figure 5] This is a plan view of the main part illustrating the light irradiation section of a phototherapy device for improving and treating mild cognitive impairment caused by Alzheimer's disease, according to one embodiment of the present invention. [Figure 6] This figure illustrates the mounting structure of a laser diode in a phototherapy device for improving and treating mild cognitive impairment caused by Alzheimer's disease, according to one embodiment of the present invention. [Figure 7] This figure illustrates the operation of the light irradiation unit of a phototherapy device for improving and treating mild cognitive impairment caused by Alzheimer's disease, according to one embodiment of the present invention. [Modes for carrying out the invention]

[0037] Preferred embodiments of the present invention will be described in detail below with reference to the accompanying drawings, and identical or similar components will be given the same reference numerals.

[0038] On the other hand, detailed explanations of the configuration, operation, and effects, which can be easily understood by those with ordinary knowledge of this field from the general technology shown in each figure, will be simplified or omitted. Furthermore, since the present invention is characterized by a phototherapy device for improving and treating mild cognitive impairment caused by Alzheimer's disease, the illustrations and explanations will focus on the parts related to this, and the explanations of the remaining parts will be simplified or omitted.

[0039] Figure 1 is a perspective view showing a phototherapy device for improving and treating mild cognitive impairment caused by Alzheimer's disease according to one embodiment of the present invention; Figure 2 is a perspective view showing the inside of the phototherapy device for improving and treating mild cognitive impairment caused by Alzheimer's disease according to one embodiment of the present invention; Figure 3 is a separated perspective view showing a therapeutic phototherapy device for improving and treating mild cognitive impairment caused by Alzheimer's disease according to one embodiment of the present invention, with some components shown separately; Figure 4 is a separated perspective view illustrating the light irradiation section of the phototherapy device for improving and treating mild cognitive impairment caused by Alzheimer's disease according to one embodiment of the present invention; and Figure 5 is a plan view of the main part illustrating the light irradiation section of the phototherapy device for improving and treating mild cognitive impairment caused by Alzheimer's disease according to one embodiment of the present invention.

[0040] Referring to Figures 1 to 5, a phototherapy device for improving and treating mild cognitive impairment caused by Alzheimer's disease according to one embodiment of the present invention comprises a head-worn body 1 worn on the user's head, which is equipped with a light irradiation unit 2 that irradiates laser light in a specific near-infrared wavelength range. The light is irradiated to the frontal lobe position, allowing it to penetrate the cerebral cortex and stimulate it, thereby enabling the improvement or treatment of early Alzheimer's disease and memory impairment-related mild cognitive impairment in a non-invasive manner.

[0041] The head-worn body 1 is a component that performs the function of a body into which the user's head is inserted and seated, and comprises an inner head case 11, an outer head case 12, a left seating guide section 13, a right seating guide section 14, a first position holding device 15, and a second position holding device, which will be described in more detail below.

[0042] The light irradiation unit 2 is a component provided on the head-worn main body 1 to irradiate light onto the frontal lobe, and is configured with a structure in which multiple laser diodes 22 are arranged on a substrate 21. Here, the laser diodes are also called ordinary LDs (Laser diodes), and compared to ordinary LEDs that simply emit light, they are capable of light modulation, and have the advantage that the pulse width and output can be adjusted in various ways and can be used for medical treatment. The substrate 21 is provided with a heat sink 23 to dissipate heat emitted from the laser diodes 22.

[0043] While the laser diode 22 can be composed of laser diodes of various wavelength bands without any special limitations, this embodiment is characterized by its combination of laser diodes of various wavelength bands, which are used to penetrate the cerebral cortex and stimulate it through a test that irradiates the prefrontal cortex, thereby being suitable for non-invasively improving or treating early Alzheimer's disease and mild cognitive impairment with memory impairment.

[0044] More specifically, the light irradiation unit 2 is composed of a mixed-type LD module 2a in which multiple laser diodes having a wavelength range of 800 nm to 1100 nm and an average output in the range of 70 mW to 340 mW are arranged.

[0045] In particular, after conducting various experiments considering the effect of improving or treating early-stage Alzheimer's disease and mild cognitive impairment with memory impairment, the mixed-type LD module 2a is characterized by being limited to a configuration consisting of multiple first laser diodes 22a with wavelengths in the range of 808±10nm and average optical output in the range of 277mW±20%, and multiple second laser diodes 22b with wavelengths in the range of 808±10nm and average optical output in the range of 100mW±20%.

[0046] Furthermore, in the mixed-type LD module 2a, the intensity of the light stimulation increases with the number of laser diodes installed, which may be advantageous for improvement or treatment. However, if the number of laser diodes is increased excessively, it can lead to serious damage to the scalp and hair due to excessive heat generation. Increasing the number of laser diodes and battery capacity during product manufacturing can also cause various problems. Therefore, it is important to configure the structure and arrangement of the laser diodes so that the internal temperature of the forehead does not exceed 41°C to 43°C. Here, it is preferable to keep the internal temperature of the forehead below 41°C.

[0047] Based on the above facts, the first laser diode 22a and the second laser diode 22b have a light energy amount of 4400 [joules / cm²] that provides an optimal light irradiation effect while preventing heat damage to the hair and scalp. 2 Through various experiments and clinical trials, we have confirmed that the prefrontal cortex must be positioned so that its distance from the scalp is within 20 mm ± 20%, without exceeding [a certain limit].

[0048] Attached Figure 6 is a diagram illustrating the laser diode mounting structure of a phototherapy device for improving and treating mild cognitive impairment caused by Alzheimer's disease according to one embodiment of the present invention, and shows a simplified mounting structure. Figure 7 is a diagram illustrating the operation of the light irradiation unit of a phototherapy device for improving and treating mild cognitive impairment caused by Alzheimer's disease according to one embodiment of the present invention, and shows the diffusion region where the light from the light irradiation unit is diffused onto the scalp. Here, the diffusion region shown with dot hatching is the diffusion region caused by light irradiated from the first laser diode 22a that forms the main light output unit a1, and the diffusion region shown with grid hatching is the diffusion region caused by light irradiated from the second laser diode 22b that forms the auxiliary light output unit a2.

[0049] Referring to Figures 5 to 7, the mixed LD module 2a consists of a left-side mixed LD module 2a' configured to irradiate the left prefrontal cortex with light, and a right-side mixed LD module 2a'' configured to irradiate the right prefrontal cortex with light.

[0050] As shown in Figure 5, the left-sided mixed LD module 2a' comprises a main light output unit a1 in which multiple first laser diodes 22a are arranged in close proximity to each other to irradiate the left prefrontal cortex, and an auxiliary light output unit a2 in which multiple second laser diodes 22b are arranged around the main light output unit a1. The area of ​​the diffusion region diffused to the scalp s at all frontal lobe locations separated by a distance of 20 mm by the irradiation of light is approximately 12 cm². 2 Light is uniformly distributed within a quadrilateral region of ±20%.

[0051] The main light output unit a1 has nine first laser diodes 22a arranged at equal intervals so as to irradiate a central rectangular area of ​​the scalp s at the location of the left prefrontal cortex with uniformly distributed light.

[0052] Preferably, the main light output section a1 has nine first laser diodes 22a with a wavelength of 808 nm and an average light output of 277 mW, arranged at equal intervals to form three rows and three columns, and is configured to form a diffused region on the scalp s at all frontal lobe positions spaced 20 mm apart as light is irradiated.

[0053] The auxiliary light output section a2 has eight second laser diodes 22b arranged in a "U" shape so that light is uniformly distributed around the lower, left, and right outer edges of the rectangular region of the main light output section 2a'.

[0054] Preferably, the auxiliary light output section a2 is provided with eight second laser diodes 22b having a wavelength of 808 nm and an average light output of 100 mW, arranged at equal intervals, and two second laser diodes are arranged on the lower side in the direction of the eye of the main light output section a1, and three second laser diodes are arranged on the left and right sides of the main light output section a1, so that non-illuminated areas of light are formed at the four corners of the rectangular region of the main light output section 2a'.

[0055] On the other hand, the right-side mixed LD module 2a'' is formed symmetrically, spaced apart from the left-side mixed LD module 2a', and includes a main optical output section a1 in which a plurality of first laser diodes 22a are arranged in close proximity to each other to irradiate the right prefrontal cortex, and an auxiliary optical output section a2 in which a plurality of second laser diodes 22b are arranged around the main optical output section a1.

[0056] The main optical output section a1 of the right-side mixed LD module 2a'' also consists of nine first laser diodes 22a arranged at equal intervals to uniformly irradiate a rectangular area in the center of the scalp at the location of the right prefrontal cortex. The detailed structure is identical or similar to that of the main optical output section a1 of the left-side mixed LD module 2a', so a detailed explanation will be omitted.

[0057] The auxiliary optical output section of the right-side mixed LD module 2a'' also consists of eight second laser diodes arranged in a "u" shape so as to irradiate light uniformly from the lower, left, and right outer edges of the rectangular area of ​​the main optical output section a1. The detailed structure is the same as or similar to the auxiliary optical output section a2 of the left-side mixed LD module 2a', so a detailed explanation will be omitted.

[0058] Furthermore, the left-sided mixed LD module 2a' and the right-sided mixed LD module 2a'' described above are arranged such that the narrow angle θ is obtuse. This incorporates a technical consideration to position the first laser diode 22a and the second laser diode 22b facing the prefrontal cortex scalp s in order to improve the light penetration characteristics into the cerebral parenchyma. Preferably, the narrow angle θ of the left-sided mixed LD module 2a' and the right-sided mixed LD module 2a'' is formed in the range of 151°±5%, taking into account the structure of the adult prefrontal cortex region, in order to form an optimal irradiation angle.

[0059] To achieve the best therapeutic effect, the first laser diode 22a applied to the left-side mixed LD module 2a' and the right-side mixed LD module 2a'' has a wavelength of 808 nm and an average light output of 277 mW, while the second laser diode has a wavelength of 808 nm and an average light output of 100 mW. The first and second laser diodes are positioned so that they are 20 mm away from the scalp at the prefrontal cortex location.

[0060] The first laser diode 22a and the second laser diode 22b are configured to have a light irradiation angle of 28°, as shown in Figure 6, and are positioned with a distance of 9 mm between the centerlines of adjacent laser diodes.

[0061] The first laser diode 22a and the second laser diode 22b are output at 42 Hz with a duty cycle of 33% under the control of the control unit, and the amount of light energy is 4390 joules / cm². 2is configured to be controlled to a smaller range. For example, the light energy amounts of the first laser diode 22a and the second laser diode 22b are 4,390[joule / cm 2 which is smaller than 4,390[joule / cm 2 , it is preferably controlled so as not to drop to 5% or less based on

[0062] In addition, when the first laser diode 22a and the second laser diode 22b, with the left mixed LD module 2a' and the right mixed LD module 2a'' configured in the optimal arrangement structure shown in FIG. 5, are mounted on the inner head case 11 of the head-worn main body 1, turned on and illuminated, as shown in FIG. 7, on the scalp at the prefrontal cortex region, there is a diffusion region of 45 mm in the horizontal direction and 36.5 mm in the vertical direction (diffusion region area: 3.6 cm × 4.5 cm = 16.2 cm 2 ), light is irradiated to have the above diffusion region, and the actual light irradiation area excluding the empty spaces at four corners (total area of the four empty spaces: 2.86 cm 2 ) is 13.34 cm 2 Therefore, on the scalp at the positions of the left and right prefrontal cortex, 12 cm 2 ±20% of the square region can be irradiated with light to exert an effective therapeutic effect.

[0063] Referring to the attached FIGS. 1 to 4, the head-worn main body is formed to have a substantially helmet shape, and comprises an inner head case 11, an outer head case 12, a left seating guide part 13, a right seating guide part 14, a first position holding device 15 and a second position holding device 16, which will be described more specifically below.

[0064] The inner head case 11 is a case located inside the head-worn main body 1 that is in contact with the head when worn, and a head seating groove 112 is recessed in the center of the edge 113 so that the upper portion of the head can be seated therein, and an LD mounting groove 114 in which the mixed LD module 2a is arranged is recessed in the forehead direction of the head seating groove 112.

[0065] The outer head case 12 is a case located on the outside of the head-worn main body, formed to surround the outside of the inner head case 11, and has a roughly helmet-like shape. A light-emitting section mounting projection 123 protrudes from the front of the outer case body 121, which houses a light-emitting section 2 including a heat sink 23.

[0066] The left-side seating guide portion 13 and the right-side seating guide portion 14 are formed on the left and right sides of the lateral head case 12 so as to sit on the temporal bone area of ​​the head, respectively, as components for maintaining a stable wearing state of the head-worn body.

[0067] The left-side seating guide section 13 and the right-side seating guide section 14 each comprise guide members 131 and 141 that extend forward from the rear of the outer head case 12, and head seating members 132 and 142 provided inside these guide members.

[0068] The head resting members 132 and 142 are formed in a shape having curved portions corresponding to the left and right shapes of the head, and are made of a material that is elastic and flexible, such as silicone, to improve adhesion and reduce pain when in contact with the temporal bone.

[0069] The first position-holding device 15 is a support device that ensures the prefrontal cortex is positioned and facing the mixed-type LD module 2a when the head-worn body 1 is worn, and that this position is stably maintained. It consists of a support leg 151, one end of which is fastened to the front edge 113 of the inner head case 11, and a seating portion 152 formed on the support leg 151 that sits on the user's forehead.

[0070] Preferably, the first position-holding device 15 is configured to allow for easy attachment and detachment of the head-worn body 1, and to allow for angle adjustment of the seating portion 152 to accommodate the detailed head shapes of different wearers.

[0071] The second position-holding device 16 is a support device that sits on the back of the user's head so that the light-emitting unit 2 is localized to the prefrontal cortex. One end of the second position-holding device 16 is attached to the rear edge 113 of the inner head case 11, which is opposite the first position-holding device 15, and the other end sits on the back of the user's head. Here, the second position-holding device 16, like the first position-holding device 15, consists of a support leg 161, one end of which is attached to the rear edge 113 of the inner head case 11, and a seating portion 162 formed on the support leg 161 that sits on the back of the user's head.

[0072] On the other hand, the LD mounting groove 114 formed in the head-worn body 1 is configured such that the left LD mounting groove 114a, to which the left mixed type LD module 2a' is attached, and the right LD mounting groove 114bv, to which the right mixed type LD module 2a'' is attached, are in communication with each other.

[0073] In particular, the left LD mounting groove 114a and the right LD mounting groove 114b are recessed so that the distance between the first laser diode 22a and the second laser diode 22b and the scalp at the prefrontal cortex is within the range of 20 mm ± 20%, while the left LD mounting groove 114a and the right LD mounting groove 114b are formed with an inclination to have a narrow angle θ.

[0074] Preferably, the left LD mounting groove 114a and the right LD mounting groove 114b are recessed to such a depth that the distance between the forehead seating surface of the seating portion 152 of the first position holding device 15 and the surface of the inner head case 11, and the recess depth of the left LD mounting groove 114a and the right LD mounting groove are in the range of 20 mm ± 20%.

[0075] Furthermore, the left LD mounting groove 114a and the right LD mounting groove 114b are formed with a narrow angle between them inclined within the range of 151°±5%, similar to the substrate narrow angle θ of the left mixed type LD module 2a' and the right mixed type LD module 2a'' described above.

[0076] On the other hand, a phototherapy device for improving and treating mild cognitive impairment caused by Alzheimer's disease according to one embodiment of the present invention includes an input unit (not shown) which is a power button for the user to input power on / off operation, selection of usage mode, usage time, etc., a wear detection sensor (not shown) attached to sense whether the user is wearing the device, and an interlock (not shown) for ensuring the normal operation of the dementia treatment device, but a detailed explanation of these will be omitted. In addition, among the components of the head-worn body 1 shown in Figures 1 to 3, the explanation of non-important components will be omitted, and the shape of the head-worn body 1 can be varied in various ways other than those shown in Figures 1 to 3, as long as the light irradiation unit 2 can be held in a stable position.

[0077] The following briefly describes the action of a phototherapy device for improving and treating mild cognitive impairment caused by Alzheimer's disease according to one embodiment of the present invention.

[0078] This report briefly describes the results of a clinical trial conducted to verify a phototherapy device for improving and treating mild cognitive impairment caused by Alzheimer's disease, according to one embodiment of the present invention. (The following clinical trial was conducted at the request of the Department of Neurosurgery at Gangnam Pedro Hospital in South Korea. Protocol NO: t-PBM)

[0079] This clinical trial included patients with mild cognitive impairment and mild Alzheimer's disease. Their medical history, K-MMSE scores, CDRs, MRI scans, concomitant medications, and treatments were investigated, and participants were selected according to standard criteria in this field for inclusion and exclusion.

[0080] Participants who met the selection / exclusion criteria and provided written consent to participate in this clinical trial were randomly assigned to either the treatment group or the control group upon their visit. During the clinical trial, participants received the clinical trial medical device once daily, six times a week, for 12 weeks (72 sessions in total).

[0081] After obtaining baseline results by performing MoCA-K and K-MMSE tests before the application of the medical device, efficacy and safety were evaluated by performing MoCA-K and K-MMSE tests at weeks 7 and 13 of medical device application.

[0082] The efficacy was evaluated using statistical analysis methods. The primary efficacy evaluation criterion was the change in total score for the MoCA-K test at 13 weeks compared to baseline, and the secondary efficacy evaluation criterion was the change in total score for the MoCA-K test at 7 weeks compared to baseline, as well as the change in total scores for the K-MMSE, CERAD-K, and GDeps tests at 7 and 13 weeks compared to baseline. Of the 26 planned participants selected through the defined clinical participant selection criteria (omitted), 23 participated in the clinical trial, using the drug for 11 minutes and 7 seconds per day, 6 times a week, for 12 weeks.

[0083] As described above, the results of the clinical trial are summarized in [Table 1] and [Table 2] regarding the change in total score for the MoCA-K test. Here, the MoCA-K test is also called the K-MoCA test (Korean-Montreal Cognitive Assessment). MoCA was developed to screen for mild cognitive impairment at an early stage, and MoCA evaluates various cognitive domains such as attention, executive function, memory, language ability, visuospatial construction ability, conceptual thinking, calculation ability, and orientation. K-MoCA is the Korean version of MoCA. The K-MoCA test takes approximately 10-15 minutes to administer, and the maximum score is 30 points.

[0084] In the table below, N represents the number of people, Mean represents the mean, SD represents the standard deviation, Median represents the median, Min represents the minimum value, Max represents the maximum value, and IQR represents the interquartile range, all interpreted as having statistical significance. The p-value (significance probability) is the probability that the test statistic of the observed data supports the null hypothesis (usually, if it is small than 0.05, the null hypothesis is rejected and it is judged to be statistically significant). In the table below, the superscript 'a' at the end of the p-value represents the repeated measures ANOVA at baseline, 7 weeks, and 13 weeks; 'b' represents the baseline-adjusted ANOVA at 13 weeks; 'c' represents the baseline-adjusted ANOVA at 7 weeks; 'd' represents the baseline two-sample t-test; 'e' represents the two-sample t-test at 7 weeks; 'f' represents the two-sample t-test at 13 weeks; 'g' represents the baseline-compared paired t-test at 13 weeks; and 'h' represents the baseline-compared paired t-test at 7 weeks.

[0085] In the case of FAS, MoCA-K refers to the analysis of the entire analysis set (Full Analysis Set, FAS), while in the case of PPS, MoCA-K refers to the analysis of the Per-Protocol set (PPS) of FAS analysis subjects who do not violate the selection / exclusion criteria and have a medical device compliance rate of 80% or higher.

[0086] [Table 1]

[0087] Table 1 shows the change in MoCA-K scores on the FAS. Referring to this table, the FAS score increased by 2.54±2.40 points in the test group and 0.46±2.33 points in the control group at 7 weeks compared to baseline. Repeated measures ANOVA was performed to compare the total MoCA-K scores at baseline, 7 weeks, and 13 weeks, and a significant difference was found between the two groups (p=0.031). Furthermore, a covariance analysis at 7 weeks, adjusted for baseline, also showed a significant difference between the two groups (p=0.037). Analysis of the total MoCA-K scores between the test group and the control group at 7 weeks also showed a significant difference (p=0.034).

[0088] A paired t-test was performed to examine the within-group differences in MoCA-K total scores. The results showed that the test group had a significant increase in scores at 7 weeks compared to baseline (p=0.002), while the control group did not show a significant difference (p=0.489).

[0089] [Table 2]

[0090] Table 2 shows the change in MoCA-K score for PPS. Referring to this table, at week 7, the PPS score increased by 2.00±2.19 points in the test group and 0.33±2.34 points in the control group compared to baseline. Repeated measures ANOVA was performed to compare MoCA-K total scores between baseline, week 7, and week 13. The results showed a significant difference between the two groups (p=0.019), and a significant difference was also found in the analysis of MoCA-K total scores between the test group and the control group at week 7 (p=0.030). However, after adjusting for baseline, there was no significant difference between the two groups in the analysis of covariance at week 7 (p=0.166).

[0091] A paired t-test was performed to examine the within-group differences in MoCA-K total scores. The results showed that the test group had a significant increase in scores at 7 weeks compared to baseline (p=0.013), while the control group did not show a significant difference (p=0.638).

[0092] These results suggest that the phototherapy device according to the present invention has clinical efficacy in improving cognitive function based on MoCA-K, and the consistent results obtained at 7 and 13 weeks particularly support its therapeutic potential.

[0093] Meanwhile, the changes in total score for the K-MMSE test are summarized in [Table 3] and [Table 4]. The K-MMSE test is the most widely used and representative test for easily and quickly measuring and screening cognitive impairment, as the Korean version of the Mini-Mental State Examination. Clinically, it can be applied not only to dementia and delirium but also to subjects who show signs of other cerebral temperament problems. The MMSE is designed to measure various cognitive functions in 5-10 minutes and has proven psychometric properties such as reliability and validity. It also has the advantage of being able to quantitatively assess the degree of cognitive impairment and observe changes in cognitive function through repeated measurements. Furthermore, the K-MMSE comprehensively evaluates orientation to time and place, memory, calculation ability, language ability, spatiotemporal construction ability, etc., and is mainly used to track overall changes in cognitive function and as an auxiliary indicator for screening diagnosis.

[0094] [Table 3]

[0095] Table 3 shows the change in K-MMSE score using FAS. Referring to this, a two-sample t-test was performed on the K-MMSE total score of the test group and the control group at baseline, 7 weeks, and 13 weeks using FAS. The results showed no significant difference between the two groups at 7 weeks, but a significant difference was observed at 13 weeks (baseline, 7 weeks, and 13 weeks: p=0.613, p=0.187, and p=0.004, respectively). Repeated measures ANOVA was performed to compare the change in K-MMSE total score at 7 weeks and 13 weeks compared to baseline, and the results showed no significant difference between the two groups (p=0.094). Analysis of covariance at 13 weeks, adjusted for baseline, showed a significant difference between the two groups (p<0.001: the change in baseline at 13 weeks was 1.85±0.90 for the test group and 0.39±1.33 for the control group, respectively), but there was no significant difference at 7 weeks (p=0.056: the change in baseline at 7 weeks was 0.54±1.90 for the test group and 0.92±1.85 for the control group, respectively).

[0096] Due to intragroup differences, pairedt-test analyses were performed at 7 and 13 weeks relative to baseline. The results showed that the test group did not show a significant difference at 7 weeks relative to baseline, but showed a significant difference at 13 weeks (p=0.327 and p<0.001, respectively), while the control group did not show a significant difference at either 7 or 13 weeks (p=0.316 and p=0.097, respectively).

[0097] [Table 4]

[0098] Table 4 shows the change in K-MMSE score for PPS, and referring to this, we confirmed the same results for PPS as for FAS. Two-sample t-tests were used to analyze the K-MMSE total scores of the test group and control group at baseline, 7 weeks, and 13 weeks. The results showed no significant difference between the two groups at 7 weeks, but a significant difference was observed at 13 weeks (p=0.849, p=0.131, and p=0.006 for baseline, 7 weeks, and 13 weeks, respectively). Repeated measures ANOVA was performed to compare the change in K-MMSE total score at 7 weeks and 13 weeks compared to baseline, and the results showed no significant difference between the two groups (p=0.067). Analysis of covariance at 13 weeks, adjusted for baseline, showed a significant difference between the two groups (p<0.001: the change in baseline at 13 weeks for the test group was an increase of 1.73±0.91 points and the change in baseline at 13 weeks for the control group was a decrease of 0.50±1.31 points, respectively), but there was no significant difference at 7 weeks (p=0.053: the change in baseline at 7 weeks for the test group was an increase of 0.55±1.97 points and the change in baseline at 7 weeks for the control group was a decrease of 1.08±1.83 points, respectively).

[0099] Due to intragroup differences, paired t-test analyses were performed at 7 and 13 weeks relative to baseline. The results showed that the test group had no significant difference at 7 weeks relative to baseline, but showed a significant difference at 13 weeks (p=0.380 and p<0.001, respectively), while the control group showed no significant difference at either 7 or 13 weeks (p=0.214 and p=0.065, respectively).

[0100] In summary, the change in K-MMSE total score at 13 weeks compared to baseline was 1.85 ± 0.90 points in the test group, compared to a decrease of 0.39 ± 1.33 points in the control group. Analysis of covariance at 13 weeks, adjusted for baseline, showed a significant difference between the two groups (p<0.001). This suggests that the phototherapy device according to the present invention has the potential to improve K-MMSE scores in the long term.

[0101] Furthermore, in the within-group analysis, the test group showed a significant score increase compared to baseline at 13 weeks (p<0.001), while the control group showed no significant change (p=0.097). These results suggest that the phototherapy device according to the present invention may have a positive effect on improving cognitive function, based on the K-MMSE score.

[0102] The terms "contains," "constitutes," or "possesses," as used above, should be interpreted, unless otherwise stated, as meaning that the constituent element may be inherent, and that it may further contain other constituent elements, rather than excluding them. All terms, including technical or scientific terms, have the same meaning as generally understood by a person of ordinary skill in the art to which this invention pertains, unless otherwise defined. Commonly used terms, such as those defined in dictionaries, should be interpreted as corresponding to their meaning in the context of the relevant technology, and not as ideal or overly formal unless explicitly defined in this invention.

[0103] The configuration and operation of the phototherapy device for improving and treating mild cognitive impairment caused by Alzheimer's disease according to one embodiment of the present invention have been described above. However, this is illustrative, and those with ordinary skill in the art will understand that it is possible to substitute and modify parts of the above-described embodiments without departing from the technical spirit of the present invention.

[0104] Therefore, it should be understood that the scope of protection of the present invention extends to the invention described in the claims and its equivalents. [Explanation of symbols]

[0105] 1: Head-worn main body 11: Inner head case 12: Outer head case 13: Left-side seating guide section 14: Right-side seating guide section 15: 1st position holding device 16:Second position holding device 2: Light-irradiating section 2a: Mixed-type LD module 2a': Left-side mixed type LD module 2a”: Right-side mixed type LD module 21: Circuit board 22: Laser Diode 22a: First laser diode 22b: Second laser diode 23: Heatsink a1: Main optical output section a2: Auxiliary light output section

Claims

1. A head-worn device that is worn on the user's head, The head-worn body includes a light-emitting section, which is positioned to irradiate light onto the frontal lobe, and has multiple laser diodes arranged on a substrate. The phototherapy device for improving and treating mild cognitive impairment caused by Alzheimer's disease is characterized in that the laser diode is composed of a mixed-type LD module in which a plurality of laser diodes having a wavelength band in the range of 800 nm to 1100 nm and an average output in the range of 70 mW to 340 mW are arranged.

2. The phototherapy device for improving and treating mild cognitive impairment caused by Alzheimer's disease according to claim 1, characterized in that the mixed-type LD module includes a plurality of first laser diodes configured to have a wavelength of 808 ± 10 nm and an average optical output in the range of 277 mW ± 20%, and a plurality of second laser diodes configured to have a wavelength of 808 ± 10 nm and an average optical output in the range of 100 mW ± 20%.

3. The first and second laser diodes have a light energy output of 4400 [joules / cm²] that provides optimal light irradiation while preventing scalp damage due to heat. ２ The phototherapy device for improving and treating mild cognitive impairment due to Alzheimer's disease according to claim 2, characterized in that the distance between the frontal lobe position and the scalp is within the range of 20 mm ± 20% so as not to exceed ].

4. The aforementioned mixed-type LD module is A left-side mixed-type LD module comprising: a main light output section in which a plurality of first laser diodes are arranged in close proximity to each other so as to irradiate the left prefrontal cortex with light; and an auxiliary light output section in which a plurality of second laser diodes are arranged around the main light output section; The phototherapy device for improving and treating mild cognitive impairment due to Alzheimer's disease according to claim 3, comprising a main optical output unit in which a plurality of first laser diodes are arranged in close proximity to each other so as to be spaced apart from the left-side mixed LD module and to irradiate the right prefrontal cortex with light, and an auxiliary optical output unit in which a plurality of second laser diodes are arranged around the main optical output unit.

5. The left-side mixed LD module and the right-side mixed LD module each have a light diffusion area of ​​12 cm² diffused onto the scalp. ２ To achieve a ±20% accuracy, the main light output unit is configured such that nine first laser diodes are arranged at equal intervals to uniformly irradiate a rectangular area on the scalp at the left prefrontal cortex and a rectangular area on the scalp at the right prefrontal cortex, and the auxiliary light output unit is configured such that eight second laser diodes are arranged in a "U" shape to uniformly irradiate light from the lower, left, and right outer edges of the rectangular area. The phototherapy device for improving and treating mild cognitive impairment caused by Alzheimer's disease according to claim 4, characterized in that the left-side mixed LD module and the right-side mixed LD module are arranged such that the narrow angle forms an obtuse angle in order to improve the light penetration characteristics into the cerebral parenchyma, and the first laser diode and the second laser diode are configured to face the prefrontal cortex.

6. The first laser diode has a wavelength of 808 nm and an average light output of 277 mW, and the second laser diode has a wavelength of 808 nm and an average light output of 100 mW. The first and second laser diodes are arranged so that they are 20 mm away from the scalp at the location of the prefrontal cortex. The first and second laser diodes are output at 42 Hz with a duty cycle of 33% under the control of the control unit, and the amount of light energy is 4390 joules / cm². ２ It is configured to be controlled to be within a smaller range than ] The main optical output section is composed of nine first laser diodes arranged at equal intervals. The auxiliary light output unit is the 12 cm ２ The phototherapy device for improving and treating mild cognitive impairment caused by Alzheimer's disease according to claim 5, characterized in that it is composed of the second laser diodes, two on the bottom and three each on the left and right sides, such that non-irradiated areas of light are formed at four corners of a ±20% square region.

7. The head-worn body is configured with an LD mounting groove in which the mixed-type LD module is mounted, recessed such that the distance between the first laser diode and the second laser diode and the scalp at the prefrontal cortex is within 20 mm ± 20%. The LD mounting groove portion consists of a left LD mounting groove portion where the left-side mixed type LD module is arranged, and a right-side LD mounting groove portion where the right-side mixed type LD module is arranged. The phototherapy device for improving and treating mild cognitive impairment due to Alzheimer's disease, according to any one of claims 4 to 6, characterized in that the narrow angles of the left-side mixed LD module and the right-side mixed LD module are formed with an angle inclination within the range of 151° ± 5%.

8. The head-worn body is, The inner head case, in which the LD mounting groove is formed and the head is seated, An outer head case provided on the outside of the inner head case, A left-side seating guide section and a right-side seating guide section are formed on the left and right sides of the head, respectively, A first position-holding device that sits on the user's forehead so that the LD mounting groove is positioned in the prefrontal cortex, The device includes a second position-holding device that is seated on the back of the user's head so that the LD mounting groove is positioned in the prefrontal cortex, The phototherapy device for improving and treating mild cognitive impairment due to Alzheimer's disease according to claim 7, characterized in that the left LD mounting groove and the right LD mounting groove are recessed such that the distance between the forehead seating surface of the first position holding device and the surface of the inner head case and the recess depth of the left LD mounting groove and the right LD mounting groove are in the range of 20 mm ± 20%.

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