Electrical stimulator

Abstract

The present invention provides an electrical stimulator capable of more effectively improving a cerebral dysfunction. The electrical simulator of the invention is equipped with: a main body having at least two pairs of channels for outputting preset electrical signals from positive and negative output sections; at least two pairs of electrodes detachably attached to a living body for applying the electrical signals to the living body; and cables for connecting the at least two channels of the main body to the at least two electrodes. This electrical simulator is characterized in that: the two pairs of electrodes are to be attached in such a manner that one electrode pair is attached to two specific positions on the right side of the body and the other electrode pair is attached to two specific positions on the left side of the body to thereby apply electrical stimulation to the brain without passing through the brainstem; and these two pairs of electrodes are visually distinguishable from each other so as to enable the recognition of the difference in the attachment purposes, and apply different electrical signals to the specific positions from each other.

Description

Electrical stimulation device

[0001] The present invention relates to a technique for recovering from brain dysfunction using an electrical stimulation device that applies an electrical signal to a living body.

[0002] Patent Document 1 describes an electrical stimulation device for recovering from brain dysfunction, which can stimulate the brain of a living organism by intermittently applying electrical signals to the organism while electrodes are positioned on at least one part of the palm, back of the hand, sole or top of the foot (for example, the ball of the hand and the toes).

[0003] Patent Document 2 describes an electrical stimulation device that includes head electrodes attached to specific locations (e.g., at least one, preferably at least two locations, among the temples, forehead above the eyes, cheeks, and back of the neck) that can stimulate the brain without passing through the brainstem in the area from the patient's neck to the top of the head, and preferably further includes an auxiliary electrode attached to a location on the patient's body lower than the neck (e.g., the back). Patent Document 2 also describes applying a weak current that repeats a predetermined cycle to the head electrodes of the electrical stimulation device, and setting multiple head electrodes, or the head electrode and auxiliary electrode, to gradually desynchronize and then resynchronize at regular intervals.

[0004] JP 2009-153904 A (Patent No. 5053826) Patent No. 5345256

[0005] An object of the present invention is to provide an electrical stimulation device that can more effectively improve brain dysfunction.

[0006] The inventor has found that the effect of improving brain dysfunction can be improved by increasing the amount of electricity, i.e., the amount of information, passing through the corpus callosum of the electrical signal applied from the electrical stimulation device. More specifically, when a pair of electrodes (two electrodes in one set) for attaching to two positions on the right half of the body (for example, the right neck) and a pair of electrodes for attaching to two positions on the left half of the body (for example, the left neck) are used as the electrodes for applying the electrical signal, and the electrical signals applied from the electrode for the right neck and the electrode for the left neck are different from each other, the amount of information sent from each brain to the contralateral brain via the corpus callosum can be increased, and the increase in the amount of information via the corpus callosum is thought to activate the metabolism of the nerve fibers in the corpus callosum, causing nerve fiber hypertrophy, etc., thereby improving the effect of improving brain dysfunction.

[0007] That is, the present invention encompasses at least the following inventions related to "electrical stimulation devices." [Item 1] An electrical stimulation device comprising: a main body having at least two sets of channels for outputting a set electrical signal from a positive electrode output unit and a negative electrode output unit; at least two sets of electrode pairs detachably attached to a living body for applying the electrical signal to the living body; and a cable for connecting the at least two sets of channels of the main body to the at least two sets of electrode pairs, wherein the two sets of electrode pairs are visually distinguishable from each other so that the difference in their uses can be recognized, and different electrical signals are applied to the specific positions. [Item 2] The electrical stimulation device according to Item 1, wherein the specific positions include two positions in the neck and head selected from the group consisting of the temples, the forehead above the eyes, the cheeks, and the back of the neck. [Item 3] The electrical stimulation device according to Item 2, wherein the two sets of electrode pairs are pre-arranged at positions corresponding to the specific positions including two positions on the neck and head in a headgear-type wearing device that is worn on the wearer's head. [Item 4] The electrical stimulation device according to Item 2 or 3, wherein the current value of the electrical signal applied to the specific positions including the two positions on the neck and head is set in the range of 1 to 1000 μA. [Item 5] The electrical stimulation device according to any one of Items 1 to 4, wherein the specific positions include two positions other than the neck and head selected from a region from the palm to the back of the hand, a region from the sole to the top of the foot, and a region on the back along the spinal cord. [Item 6] The electrical stimulation device according to Item 5, wherein the two sets of electrode pairs are pre-arranged at positions corresponding to the specific positions including the two positions other than the neck and head in a semi-glove- or semi-sock-shaped wearing device that is worn on the wearer's hand or foot. [Item 7] The electrical stimulation device according to Item 5 or 6, wherein the current value of the electrical signal applied to the specific positions including the two positions other than the neck and head is set in the range of 1 to 1000 mA.[Item 8] The electrical stimulation device of any one of Items 1 to 7, wherein the electrical signal applied to the specific position is configured to: (1) repeat a cycle including a first state in which positive and negative pulse waves are alternately generated, and a second state in which the pulse waves are paused, or (2) include, in this order, a first state in which pulse waves that are always positive or negative are generated, a second state in which the pulse waves are paused, a third state in which pulse waves that are the opposite of the first state are generated, and a fourth state in which the pulse waves are paused. [Item 9] The electrical stimulation device of Item 8, wherein the electrical signal applied from one electrode pair and the electrical signal applied from the other electrode pair of the two electrode pairs are configured such that in the electrical signal of (1), the duration of either or both of the first state and the second state is different between the two electrodes, or in the electrical signal of (2), the duration of at least one of the first state, the second state, the third state, and the fourth state is different between the two electrodes. [Item 10] The electrical stimulation device according to item 8, wherein the electrical signal applied from one of the two electrode pairs and the electrical signal applied from the other electrode pair are set so that, in the electrical signal (2), the application of the pulse wave between the electrodes in the first state is reversed and the application of the pulse wave between the electrodes in the fourth state is reversed. [Item 11] The electrical stimulation device according to any one of items 1 to 10, wherein the frequency of the electrical signal is set in the range of 10 to 80 pps (pulses per second). [Item 12] The electrical stimulation device according to any one of items 1 to 11, which is a medical device for treating brain dysfunction.

[0008] Furthermore, the above invention relating to an "electrical stimulation device" can be converted into an invention relating to an "electrical stimulation method." That is, the present invention also encompasses the following invention relating to an "electrical stimulation method." Change [Item 1'] An electrical stimulation method using at least two pairs of electrodes, wherein one pair of electrodes is attached to two specific locations on the right half of the body and the other pair of electrodes is attached to two specific locations on the left half of the body so that electrical stimulation can be applied to the brain without passing through the brainstem, and wherein different electrical signals are applied to the specific locations by the two pairs of electrodes. [Item 1A'] The electrical stimulation method according to Item 1', wherein the two pairs of electrodes are included in an electrical stimulation device comprising: a main body having at least two pairs of channels for outputting set electrical signals from a positive electrode output unit and a negative electrode output unit; a cable for connecting the at least two pairs of electrodes to the at least two pairs of channels of the main body; and at least two pairs of electrodes detachably attached to a living body for applying electrical signals to the living body. [Item 1B'] The electrical stimulation method according to Item 1' or 1'A, wherein the two sets of electrode pairs are visually distinguishable from each other so that the difference in the purpose of wearing them can be recognized. [Item 2'] The electrical stimulation method according to Item 1', 1'A, or 1'B, wherein the specific positions include two positions on the neck selected from the temples, the forehead above the eyes, the cheeks, and the back of the neck. [Item 3'] The electrical stimulation method according to Item 2', wherein the two sets of electrode pairs are placed at positions corresponding to the specific positions including the two positions on the neck using a headgear-type wearing device that is worn on the wearer's head. [Item 4'] The electrical stimulation method according to Item 2' or 3', wherein the current value of the electrical signal applied to the specific positions including the two positions on the neck is set in the range of 1 to 1000 μA. [Item 5'] The electrical stimulation method according to Item 1' to 4', wherein the specific positions include two positions other than the neck selected from the region from the palm to the back of the hand, the region from the sole to the top of the foot, and the region on the back along the spinal cord. [Item 6'] The electrical stimulation method according to Item 5', wherein the two electrode pairs are pre-positioned at positions corresponding to specific positions including two locations other than the neck and head in a semi-glove-like or semi-sock-like wearing device that is attached to the wearer's hand or foot.[Item 7'] The electrical stimulation method according to item 5' or 6', wherein the current value of the electrical signal applied to the specific position, including the two positions other than the neck and head, is set in the range of 1 to 1000 mA. [Item 8'] The electrical stimulation method according to any one of items 1' to 7', wherein the electrical signal applied to the specific position is set to (1) repeat a cycle including a first state in which positive and negative pulse waves are alternately generated, and a second state in which the pulse waves are paused, or (2) is set to include, in this order, the first state in which pulse waves that are always positive or negative pulse waves are generated, the second state in which the pulse waves are paused, a third state in which pulse waves that are applied in the opposite direction to the first state are generated, and a fourth state in which the pulse waves are paused. [Item 9'] The electrical stimulation method according to Item 8', wherein the electrical signal applied from one electrode pair of the two electrode pairs and the electrical signal applied from the other electrode pair are configured such that in the electrical signal (1), the duration of either or both of the first state and the second state is different between the electrodes, or in the electrical signal (2), the duration of at least one of the first state, the second state, the third state, and the fourth state is different between the electrodes. [Item 10'] The electrical stimulation method according to Item 8', wherein the electrical signal applied from one electrode pair of the two electrode pairs and the electrical signal applied from the other electrode pair are configured such that in the electrical signal (2), the application of pulse waves is reversed between the electrodes in the first state and the application of pulse waves is reversed between the electrodes in the fourth state. [Item 11'] The electrical stimulation method according to any one of Items 1' to 10', wherein the frequency of the electrical signal is set in the range of 10 to 80 pps (pulses per second). [Item 12'] The electrical stimulation method according to any one of Items 1' to 11', which is for treating brain dysfunction.

[0009] By using the electrical stimulation device of the present invention, it becomes possible to carry out a method for improving brain dysfunction with improved effectiveness, and it is also possible to improve the IQ of children with brain damage, for example.

[0010] The electrical stimulation device described in Patent Document 2 is said to be able to stimulate the brain more effectively than the electrical stimulation device described in Patent Document 1, which stimulates the peripheral nerves, thereby improving brain function more effectively. However, the electrical stimulation devices described in Patent Document 1 and Patent Document 2 are designed to be worn on the hands or feet, and on the neck to the top of the head, with one electrode of a pair of electrodes worn on the right side of the body and the other electrode worn on the left side of the body, i.e., a pair of electrodes worn on both sides. When used in this manner, electrical stimulation applied from one electrode (e.g., the right side of the body) is sent from one brain (e.g., the right brain) to the contralateral brain (e.g., the left brain) via the corpus callosum and then flows to the other electrode (e.g., the left side of the body). Unlike the prior art, the present invention transmits information via the corpus callosum in a manner that increases the amount of information passing through the corpus callosum, thereby achieving effects different from those of the prior art.

[0011] FIG. 1 is a simplified perspective view of an example of an electrical stimulation device of the present invention. FIG. 2 is a schematic diagram of one embodiment of the present invention (first embodiment of electrical stimulation). a-d represent the lengths of the first, second, third, and fourth states of the electrical stimulation applied by the first electrode pair connected to the first channel (Ch1), and a'-d' represent the lengths of the first, second, third, and fourth states of the electrical stimulation applied by the second electrode pair connected to the second channel (Ch2). In this embodiment, a = a' and c = c', but b ≠ b' and d ≠ d', resulting in a delay (asynchronous) in the applied electrical stimulation (pulse wave). Furthermore, h1 and h2 represent the current values ​​of the pulse waves in the first and second states of the electrical stimulation applied by the first electrode pair, and h1' and h2' represent the current values ​​of the pulse waves in the first and third states of the electrical stimulation applied by the second electrode pair. In this embodiment, h1 = h2, and h1' = h2'. FIG. 3 is a schematic diagram of one embodiment of the present invention (a second embodiment of electrical stimulation). a-d, h1, and h2, as well as a'-d', h1', and h2', are the same as those in FIG. 2. However, the pulse waves in the first state of the electrical stimulation applied by the first electrode pair and the pulse waves in the first state of the electrical stimulation applied by the second electrode pair are opposite in positive and negative polarity, and the pulse waves in the third state of the electrical stimulation applied by the first electrode pair and the pulse waves in the third state of the electrical stimulation applied by the second electrode pair are also opposite in negative and positive polarity. Therefore, the applied electrical stimulations (pulse waves) are not synchronized at all.

[0012] REFERENCE SIGNS LIST 1 Electrical stimulation device 10 Main unit 11 First channel (one set of channels) 11a First output unit of first channel 11b Second output unit of first channel 12 Second channel (one set of channels) 12a First output unit of second channel 12b Second output unit of second channel 21 First electrode pair (one set of electrode pair) 21a First electrode of first electrode pair 21b Second electrode of first electrode pair 31a First cable of first electrode pair 31b Second cable of first electrode pair 41a First terminal of first electrode pair 41b Second terminal of first electrode pair 22 Second electrode pair (one set of electrode pair) 22a First electrode of second electrode pair 22b Second electrode of second electrode pair 32a First cable of second electrode pair 32b Second cable of second electrode pair 42a: First terminal of second electrode pair; 42b: Second terminal of second electrode pair

[0013]

[0014] -Electrical stimulation device- The electrical stimulation device of the present invention is an electrical stimulation device comprising a main body having at least two sets of channels for outputting a set electrical signal from a positive electrode output unit and a negative electrode output unit, at least two sets of electrode pairs that are detachably attached to the living body for applying the electrical signal to the living body, and a cable for connecting the at least two electrodes to the at least two channels of the main body, wherein the two sets of electrode pairs are designed to be attached to two specific positions on the right half of the body and the other electrode pair to two specific positions on the left half of the body so that electrical stimulation can be applied to the brain without passing through the brainstem, and are visually distinguishable from each other so that the different uses of such attachment can be recognized, and different electrical signals are applied to the specific positions.

[0015] DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The present invention will be described in more detail below with reference to the accompanying drawings, in which: Fig. 1 shows a simplified perspective view of an example of an electrical stimulation device according to the present invention;

[0016] The electrical stimulation device 1 includes a main unit 10 that outputs a preset electrical signal, two electrode pairs and cables, i.e., a first electrode pair 21 (electrodes 21a and 21b) and a cable 31 (cables 31a and 31b, each including terminal portions 41a and 41b) connecting the first electrode pair 21 to the main unit 10, and a second electrode pair 22 (electrodes 22a and 22b) and a cable 32 (cables 32a and 32b, each including terminal portions 42a and 42b) connecting the second electrode pair 22 to the main unit 10. An electrical circuit (not shown) connected to an output section for generating the preset electrical signal is provided within the main unit 10.

[0017] The main body 10 has a total of eight pairs of channels, each pair consisting of two output sections: a first channel 11 (output sections 11a and 11b), a second channel 12 (output sections 12a and 12b), a third channel 13, and an eighth channel 18. In the embodiment shown in FIG. 1 , the main body 1 has a total of eight pairs of channels, but it is sufficient to have at least two pairs of channels so that the first electrode pair 21 (electrodes 21a and 21b) and the second electrode pair 22 (electrodes 22a and 22b) can each be connected to one pair of channels. In each channel, one output section is a positive output section, and the other output section is a negative output section. For example, in the first channel 11, the output section 11a can be a positive output section, and the output section 11b can be a negative output section.

[0018] The electrodes are arranged in pairs of two. When connected to the positive output terminal of each channel of the main unit 10 via their respective cables and terminals, electrodes 21a, 21b, 22a, and 22b function as positive electrodes, and when connected to the negative output terminal, they function as negative electrodes. A positively applied electrical signal (pulse wave) flows through the body from the positive electrode connected to the positive output terminal to the negative electrode connected to the negative output terminal. Conversely, a negatively applied electrical signal flows through the body from the negative electrode connected to the negative output terminal to the positive electrode connected to the positive output terminal. The electrical signals of each channel can be independently controlled by a program.

[0019] In the present invention, as described separately, the electrical signals (pulse waves) applied to the living body from one (first electrode pair) and the other (second electrode pair) of the two electrode pairs have waveforms different from each other, but the electrical signals themselves applied to the living body from each electrode pair, i.e., the electrical signals themselves output from each channel of the main body 10 connected to each of those electrode pairs, can be made to conform to conventional electrical signals.

[0020] The electrical signal (pulse wave) applied to the living body can be set to repeat a cycle that includes, for example, a state in which the pulse wave is generated (referred to in this specification as a "pulse wave generating state") and a state in which the pulse wave is at rest (referred to in this specification as a "pulse wave resting state").

[0021] In the pulse wave generation state, the frequency of the pulse wave is usually adjusted in the range of 10 to 80 pps (pulses per second), and can be set to 50 pps as an example. To enable the brain to perceive one pulse, the frequency is usually 80 pps or less, preferably 60 pps or less. On the other hand, if the frequency is too low, it becomes difficult to provide a sufficient number of stimuli, so the frequency is usually 10 pps or more, preferably 20 pps or more.

[0022] In addition, in the pulse wave generation state, the current value of the pulse wave may be constant, may gradually increase, or may gradually decrease. For example, the state in which the pulse wave is generated may be composed of a state in which the current value of the pulse wave gradually increases, followed by a state in which the pulse wave is constant. By including a state in which the current value of the pulse wave gradually increases, it is possible to prevent a sudden electrical stimulation from being given to the brain.

[0023] The current value of the pulse wave can be adjusted appropriately depending on the embodiment of the present invention so that an appropriate current flows within the living body. For example, when the specific positions include two locations on the neck and head (details will be described later), the current value of the pulse wave is typically adjusted within a range of 1 to 1000 μA, and can be set to 40 μA as an example. To avoid excessive stimulation of the brain, the current value is preferably 100 μA or less, and more preferably 80 μA or less. Conversely, if the current value is too small, the brain will not perceive it, so the current value is preferably 10 μA or more, and more preferably 20 μA or more. Furthermore, when the specific positions include two locations other than the neck and head (e.g., hands, feet, back, etc., details will be described later), the current value of the pulse wave can be typically adjusted within a range of 1 to 1000 mA, for example, 10 to 500 mA, and preferably 30 to 300 mA.

[0024] The pulse wave generating state, pulse wave rest state, the state in which the current value is constant in the pulse wave generating state, the state in which the current value gradually increases, and the state in which the current value gradually decreases, and the time for which the cycle is repeated can each be adjusted appropriately. For example, the pulse wave generating state and the pulse wave rest state can each be adjusted between 2 and 9 seconds. Furthermore, from the viewpoint of preventing brain fatigue, it is preferable that the time for the pulse wave rest state be the same as or longer than the time for the pulse wave generating state, and it can be, for example, twice or more.

[0025] In one embodiment of the present invention (first embodiment of pulse waves), the electrical signal applied to the living body can be set to repeat a cycle including a first state in which positive and negative pulse waves are alternately applied, and a second state in which the pulse waves are paused. In this embodiment, the duration of each of the first and second states can be adjusted, for example, between 2 and 9 seconds.

[0026] In one embodiment of the present invention (second embodiment of the pulse wave), the electrical signal applied to the living body can be set to include, in this order, a first state in which pulse waves that are always positively or negatively applied are generated, a second state in which the pulse waves are paused, a third state in which pulse waves that are applied in the opposite direction to the first state are generated, and a fourth state in which the pulse waves are paused. The current value of the positively or negatively applied pulse waves in the first state may be set to match the current value of the pulse waves that are applied in the opposite direction to the first state in the third state. The duration of each of the first to fourth states can be adjusted as appropriate, for example, between 2 and 9 seconds.

[0027] The first electrode pair 21 (electrodes 21a and 21b) and the second electrode pair 22 (electrodes 22a and 22b) are intended to be attached to two specific positions on the right half of the body and two specific positions on the left half of the body, respectively, so that electrical stimulation can be given to the brain without passing through the brainstem. Either the electrodes 21a and 21b of the first electrode pair 21 or the electrodes 22a and 22b of the second electrode pair 22 is intended to be attached to two specific positions on the right half of the body, and the other is intended to be attached to two specific positions on the left half of the body.

[0028] In one embodiment of the present invention, the specific positions may include two locations between the neck and the parietal region (referred to herein as the "neck region"), from the viewpoint of preventing stimulation via peripheral nerves from being reduced by the brainstem barrier. For example, one specific position of two electrode pairs may be two locations on the right half of the neck (referred to herein as the "right neck region"), and the other specific position may be two locations on the left half of the neck (referred to herein as the "left neck region"). Preferred specific positions on each of the right and left neck regions are, for example, two locations selected from the temple region, the forehead region above the eyes, the cheek region, and the back of the neck. One example embodiment includes an embodiment in which, of the first electrode pair, electrode 21a is attached to the temple region of the right neck region and electrode 21b is attached to the back of the neck region of the right neck region, and, of the second electrode pair, electrode 22a is attached to the temple region of the left neck region and electrode 22b is attached to the back of the neck region of the left neck region.

[0029] In one embodiment of the present invention, the specific positions may include two locations below the neck, such as a region from the palm to the back of the hand (fingertips, ball of the foot, toes, etc.), a region from the sole to the top of the foot, or a region on the back along the spinal cord. For example, one specific location of the two electrode pairs may be two locations on the right side of the body other than the neck, and the other specific location may be two locations on the left side of the body other than the neck. Alternatively, one specific location of the two electrode pairs may be two locations on the neck (e.g., on the right side of the body), and the other specific location may be two locations on the left side of the body other than the neck (e.g., on the left side of the body).

[0030] In one embodiment of the present invention, the specific positions may be a combination of at least two positions on the neck, for example, two positions on the right side of the neck and two positions on the left side of the neck, and additionally include at least two positions other than the neck, for example, two positions on the right half of the body below the neck and two positions on the left half of the body. In such a combination embodiment, the electrical stimulation device may include, for example, a first electrode pair 21 and a second electrode pair 22 for the right and left sides of the neck, respectively, and additionally include a third electrode pair (not shown) and a fourth electrode pair (not shown) for the right and left sides of the body other than the neck, respectively.

[0031] The first electrode pair 22 (electrodes 21a and 21b) and the second electrode pair 22 (electrodes 22a and 22b) are made distinguishable from each other so that one electrode is for the right half of the body and the other is for the left half of the body. This makes it easier to avoid confusing the combination of the first electrode pair 21a and the second electrode pair 22b as a pair of electrodes, and more reliably ensures that the first electrode pair 21a and 21b are both worn in a specific position on the right or left half of the body, and the second electrode pair 22a and 22b are both worn in a specific position on the opposite side. The third and fourth electrode pairs, exemplified as auxiliary electrode pairs in the above embodiment, or other electrode pairs, can also be made visually distinguishable from each other so that one electrode is for the right half of the body and the other is for the left half of the body.

[0032] The means for "making them distinguishable from one another" are not particularly limited, and various known means can be used. Examples include means that primarily distinguish them visually, such as distinguishing them by color, attaching labels with letters or symbols, or different electrode shapes. In addition to the electrodes, the cables (including terminal portions) and / or channels may also be made visually distinguishable. For example, the first electrode pair 22 (electrodes 21a and 21b), optionally the cables 31a and 31b, and the first channel 11 (output units 11a and 11b) connecting them may be colored red or labeled with the word "right." On the other hand, the second electrode pair 22 (electrodes 22a and 22b), optionally the cables 32a and 32b, and the second channel 12 (output units 12a and 12b) connecting them may be colored blue or labeled with the word "left." Pre-arranging the electrodes in a wearing device, as described below, also constitutes a means for "making them distinguishable from one another."

[0033] The properties (material, shape, etc.) of each electrode are not particularly limited as long as they are detachable from the living body, but for example, they can be pad-shaped electrodes made of a gel material (gel electrode pads). Electrodes to be attached to the right and left neck regions and electrodes to be placed on the wearing device can be sheet-shaped, while electrodes to be attached to the right and left halves of the body other than the neck region (for example, auxiliary electrodes in the embodiment described below) that are not to be placed on the wearing device can be suction cup-shaped.

[0034] In the present invention, the first electrode pair and the second electrode pair apply different electrical signals to specific positions. Typically, this can be achieved by having the first channel 11 (output units 11a and 11b) and the second channel 12 (output units 12a and 12b), which are connected to the first electrode pair 21 (electrodes 21a and 21b) and the second electrode pair 22 (electrodes 22a and 22b) via cables, output electrical signals with different waveforms. Alternatively, this can be achieved by making the specific positions where the first electrode pair 21a and 21b are attached and the specific positions where the second electrode pair 22a and 22b are attached different from each other (e.g., reversed).

[0035] The "electrical signals with different waveforms" are not particularly limited, and may be any signals that can increase the amount of information sent from each of the left and right brains to the contralateral brain via the corpus callosum, compared to electrical signals with the same waveform.

[0036] In one embodiment of the present invention (first embodiment of electrical stimulation), the electrical signal (pulse wave) of the first electrode pair 21 and the electrical signal (pulse wave) of the second electrode pair 22 are set to be different during at least one of the pulse wave generation state and the pulse wave rest state.

[0037] For example, in the first embodiment of the electrical stimulation, the duration of one or both of the first state (pulse wave generation state) and the second state (pulse wave rest state) in the first embodiment of the pulse wave of the present invention may be different. For example, the duration of the first state may be the same for both electrode pairs (e.g., 3 seconds for both), while the duration of the second state may be different (e.g., 3 seconds for the first electrode pair and 5 seconds for the second electrode pair). Also, in the first embodiment of the electrical stimulation, the duration of at least one of the first and third states (pulse wave generation states) and the second and fourth states (pulse wave rest state) in the second embodiment of the pulse wave of the present invention may be different. For example, the duration of the first and third states may be the same for both electrode pairs, while the duration of the second and fourth states may be different (e.g., the duration of the second and fourth states may be the same for each electrode pair).

[0038] As shown in FIG. 2 , in the first embodiment of electrical stimulation, the above-described settings result in a lag (asynchronous) in the timing of pulse wave generation between the first electrode pair and the second electrode pair. That is, the timing of electrical stimulation to the left and right brain gradually shifts, even if the pulse wave current magnitude and the electrical stimulation vector are the same. Because the left and right brains send such information to the contralateral brain, the need for information exchange via the corpus callosum increases. This activates the metabolism of nerve fibers in the corpus callosum, leading to the hypertrophy of nerve fibers and the formation of new neural biomolecules, thereby more effectively improving brain dysfunction. While the durations of the pulse wave generation and pulse wave pause states in each cycle may be equal, it is preferable to set the durations of the entire cycle to be different. Even if the pulse waves between the first electrode pair and the second electrode pair become asynchronous, after a certain period of time, the pulse waves eventually synchronize, then become asynchronous again, and then return to synchronization. This cycle is repeated.

[0039] In another embodiment of the present invention (second embodiment of electrical stimulation), the electrical signal (pulse wave) of the first electrode pair 21 and the electrical signal (pulse wave) of the second electrode pair are set so that the application of pulse waves in the pulse wave generation state is reversed.

[0040] For example, in the second embodiment of the electrical stimulation, the pulse wave application in the first state and the third state in the second embodiment of the pulse wave of the present invention described above is set to be reversed between both electrode pairs. As an example, the first state of the electrical signal of the first electrode pair 21 can be set to a positive application, the first state of the electrical signal of the second electrode pair 22 can be set to a negative application, the third state of the electrical signal of the first electrode pair 21 can be set to a negative application, and the third state of the electrical signal of the second electrode pair 22 can be set to a positive application. Note that the durations of the first state and the third state (pulse wave generation state), as well as the durations of the second state and the fourth state (pulse wave pause state), may be set to be the same between both electrode pairs.

[0041] As shown in Figure 3, in the second embodiment of electrical stimulation, the above-described settings result in opposite electrical stimulation vectors, resulting in independent electrical stimulation of the left and right hemispheres. For example, a positive pulse wave is applied by the first electrode pair 21, causing electrical stimulation to flow from the electrode 21a (positive electrode) attached to the right temple to the electrode 21b (negative electrode) attached to the back of the neck on the right side. Meanwhile, a negative pulse wave is applied by the second electrode pair 22, causing electrical stimulation to flow from the electrode 22a (negative electrode) attached to the back of the neck on the left side to the electrode 22b (positive electrode) attached to the left temple on the left side. Therefore, the left and right hemispheres send information to the contralateral hemisphere, which differs from the electrical signal in the first embodiment. In this case, the need for information exchange via the corpus callosum differs from the first embodiment, resulting in the hypertrophy of nerve fibers, the formation of new neural organisms, and the formation of new neural products, which are not achieved in the first embodiment, thereby enabling more effective improvement of brain dysfunction.

[0042] In one embodiment of the present invention, the two electrode pairs may be pre-arranged at positions corresponding to specific positions in a headgear-type wearing device that is worn on the wearer's head. This embodiment is suitable for an embodiment in which two electrode pairs are worn at specific locations on the left and right sides of the neck (for example, two of the temples, the forehead above the eyes, the cheeks, or the back of the neck), because one electrode pair (e.g., the first electrode pair) is automatically arranged on the right side of the neck and the other electrode pair (e.g., the second electrode pair) is arranged on the left side of the neck when the wearer wears the headgear-type wearing device on the neck.

[0043] The headgear-type wearing device is formed, for example, with an elastic sheet material to be highly stretchable. Specifically, the headgear-type wearing device has a bag-shaped main body that can be worn over the wearer's head and neck, and the front side (facing the patient's face) of the main body can be formed so that the wearer's eyes, nose, and mouth are exposed. The main body covers the wearer's top of the head, left and right sides, and the back of the head (including the upper part of the neck). Two sets of electrode pairs are arranged on the inner surface of the wearing device at positions corresponding to specific positions on the neck and head, either fixedly or detachably (e.g., using hook-and-loop fasteners). In addition, the main body can be provided with a pair of left and right extensions that extend from a position slightly below the wearer's eyes toward the nose. Furthermore, by providing an elastic string connecting the pair of left and right extensions or an elastic string connecting the front lower ends of the main body, each electrode pair can be securely attached to a specific position when the wearing device is worn. A thin elastic plate may be held within the extension portion, and the elastic force of this elastic plate may be used to ensure that the extension portion is tightly attached to the cheek of the wearer. Note that other aspects of the headgear-type wearing device of the present invention can be appropriately designed by a person skilled in the art by referring to known headgear-type wearing devices.

[0044] In one embodiment of the present invention, the two electrode pairs may be pre-arranged at positions corresponding to specific positions in a semi-glove- or semi-sock-like garment attached to the wearer's hands or feet. This embodiment is suitable for an embodiment in which two electrode pairs are attached to specific left and right regions other than the left and right neck regions, because the wearer can automatically place one electrode pair (e.g., the third electrode pair) on the right half of the body other than the neck and the other electrode pair (e.g., the fourth electrode pair) on the left half of the body other than the neck and the head by putting the garment on the wearer's hands or feet.

[0045] For example, a semi-glove-like wearing device has a main body made of, for example, a stretchable or elastic material that can be worn on the wearer's hand. The semi-glove-like wearing device may have a fastening means, such as a zipper or hook-and-loop fastener, for attaching and detaching the device from the hand, in which case it does not necessarily have to be made of a stretchable material. Two sets of electrode pairs are arranged on the inner surface of the semi-glove-like wearing device (main body) at positions corresponding to specific locations on the hand (palm or back of the hand). For example, on the inner surface of the semi-glove-like wearing device (main body) for each of the right and left hands, one set of electrode pairs is arranged at positions corresponding to the thenar eminence (first specific location) and the fingertips (second specific location). Note that other details regarding the semi-glove-like or semi-sock-like wearing device of the present invention can be appropriately designed by those skilled in the art by referring to known semi-glove-like or semi-sock-like wearing devices.

[0046] <Brain Dysfunction> The electrical stimulation device of the present invention can be used to treat brain dysfunction. That is, in one embodiment of the present invention, the electrical stimulation device of the present invention is a medical device for treating brain dysfunction. As used herein, "treatment" includes completely or partially curing brain dysfunction, completely or partially curing (alleviating or ameliorating) symptoms associated with brain dysfunction, slowing the progression of brain dysfunction or its symptoms, delaying or preventing its onset, reducing the risk of its onset, or a combination thereof. The treatment may be a non-clinical trial, a pre-clinical trial, or a clinical trial.

[0047] Examples of brain dysfunctions that can be treated, for example, that can be improved using the electrical stimulation device of the present invention, include the following: organic mental disorders including symptomatic ones, such as dementia, Korsakoff's syndrome, and sequelae of head trauma, which are mental disorders caused by large (i.e. visible to the naked eye) lesions in the brain; mental and behavioral disorders caused by the use of psychoactive substances, such as mental disorders (categorized into dependence, abuse, intoxication, etc.) associated with psychoactive substances such as alcohol, opium, cannabis, sedatives or hypnotics, cocaine, stimulants / caffeine, hallucinogens, tobacco, volatile solvents, and sugar, alcoholism, drug dependence, etc.; schizophrenia, schizophreniform disorder, and delusional disorder, such as schizophrenia, schizophreniform disorder, persistent delusional disorder, acute transient psychotic disorder, responsive delusional disorder, and schizoaffective disorder; mood disorders (also called affective disorders, which primarily affect mood), such as mania, bipolar disorder (manic depression), and depression; Neurotic, stress-related and somatoform disorders include phobic anxiety disorders (agoraphobia, social phobia), other anxiety disorders (panic disorder, generalized anxiety disorder), obsessive-compulsive disorder, severe stress disorder, severe stress reaction and adjustment disorder (PTSD and acute stress disorder are included in anxiety disorders in DSM-IV, but are classified as severe stress reactions in ICD-10), acute stress disorder, PTSD (post-traumatic stress disorder), adjustment disorder, dissociative (conversion) disorder (F44), dissociative disorder (almost all dissociative disorders in DSM-IV-TR), other dissociative (conversion) disorders, multiple personality disorder (dissociative identity disorder in DSM-IV-TR), somatoform disorders (somatization disorder, hypochondriacal disorder, persistent somatoform pain disorder), other neurotic disorders; Behavioral syndromes related to physiological disorders and physical factors include eating disorders, anorexia nervosa (anorexia nervosa), bulimia nervosa (binge eating disorder), sleep disorders, insomnia, psychophysiological insomnia (circadian rhythm sleep disorder, difficulty falling asleep, middle-of-the-night awakenings, early morning awakenings, hypersomnia, sleep apnea syndrome, narcolepsy, primary hypersomnia, recurrent hypersomnia, idiopathic hypersomnia), parasomnias, REM sleep behavior disorder, sleepwalking, and night terrors;Personality and behavioral disorders include: paranoid personality disorder, schizotypal personality disorder, antisocial personality disorder, emotionally unstable personality disorder (impulsive and borderline), histrionic personality disorder, obsessive-compulsive personality disorder, anxious [avoidant] personality disorder, dependent personality disorder, other (or unspecified or mixed) personality disorder, persistent personality change, personality and behavioral disorders not due to brain damage or disease, habit and impulse disorders, gender identity disorder, sexual preference disorders (fetishism, exhibitionism, voyeurism, pedophilia, sadism-masochism), psychological and behavioral disorders associated with sexual development and orientation, other adult personality and behavioral disorders, intentional calculation or disguise of symptoms or impairment, physical or psychological personality and behavioral disorders (factitious disorder), Munchausen syndrome; mental retardation includes intellectual disability; Disorders of psychological development include pervasive developmental disorders, autism, and Asperger's syndrome; behavioral and emotional disorders that typically develop in childhood and adolescence include attention deficit hyperactivity disorder (ADHD) (tic disorders, Tourette's syndrome); and other disorders include hallucinations, delusions, and culture-bound syndromes (neuroticism, social phobias).

[0048] Electrical Stimulation Method The electrical stimulation method of the present invention uses at least two electrode pairs, one of which is attached to two specific locations on the right side of the body and the other to two specific locations on the left side of the body, so as to electrically stimulate the brain without passing through the brainstem. The two electrode pairs apply different electrical signals to the specific locations. The two electrode pairs may be included in an electrical stimulation device that includes a main body having at least two channels for outputting set electrical signals from a positive electrode output unit and a negative electrode output unit, a cable for connecting the at least two channels of the main body to the at least two electrode pairs, and at least two electrode pairs detachably attached to the living body for applying the electrical signals to the living body. The two electrode pairs may also be visually distinguishable from each other so that the different uses for which they are attached can be recognized. The electrical stimulation method of the present invention can be implemented to treat (improve) brain dysfunction.

[0049] In this specification, the technical matters relating to the electrical stimulation method can be applied to the technical matters relating to the electrical stimulation device described above. For example, a preferred embodiment relating to the electrical stimulation device can be converted into a preferred embodiment relating to the electrical stimulation method. Conversely, in this specification, the technical matters relating to the electrical stimulation method can be applied to the technical matters relating to the electrical stimulation device.

[0050] Example 1: A male UH patient, aged 5 years and 7 months, diagnosed with autism. Treatment was performed using the electrical stimulation device of the present invention from December 12, 2014 to August 31, 2015. The electrical stimulation device was a headgear-type device equipped with electrodes that applied electrical stimulation to the temples and the back of the neck (similar to Example 2 below). Treatment frequency was 1 to 3 days per week. The patient's IQ was 58 before treatment, but increased to 67 after treatment.

[0051] Example 2: YF, a male, 11 years and 9 months old, was diagnosed with an unspecified developmental disorder in later life. He underwent treatment using the electrical stimulation device of the present invention from May 26, 2013 to June 10, 2016. The treatment frequency was 1 to 5 days per week. His IQ was 74 before treatment, but increased to 92 after treatment.

Claims

1. A main body having at least two sets of channels for outputting a set electrical signal from a positive electrode output part and a negative electrode output part; At least two sets of electrode pairs that are detachably attached to a living body for applying an electrical signal to the living body; A cable for connecting at least two sets of channels of the main body and at least two sets of electrode pairs An electrical stimulation device comprising: The two sets of electrode pairs are for attaching one electrode pair to two specific positions on the right half of the body and the other electrode pair to two specific positions on the left half of the body so as to be able to apply electrical stimulation to the brain without passing through the brainstem, and are visually distinguishable from each other so as to recognize the difference in the purpose of such attachment, and apply different electrical signals to specific positions. An electrical stimulation device characterized by this.

2. The electrical stimulation device according to claim 1, wherein the specific positions include two positions on the head including the temple part, the supraorbital part of the eye, the cheek part, and the posterior part of the neck selected from these parts.

3. In a headgear-type wearing device worn on the head of the wearer, the two sets of electrode pairs are arranged in advance at positions corresponding to the specific positions including the two positions on the head. The electrical stimulation device according to claim 2.

4. The electrical stimulation device according to claim 2, wherein the current value of the electrical signal applied to the specific positions including the two positions on the head is set in the range of 1 to 1000 μA.

5. The electrical stimulation device according to claim 1, wherein the specific positions include two positions other than the head selected from the part from the palm to the back of the hand, the part from the sole to the top of the foot, and the part of the back along the spinal cord.

6. In a semi-glove-shaped or semi-sock-shaped wearing device attached to the hand or foot of the wearer, the two sets of electrode pairs are arranged in advance at positions corresponding to the specific positions including the two positions other than the head. The electrical stimulation device according to claim 5.

7. The electrical stimulation device according to claim 5, wherein the current value of the electrical signal applied to the specific positions including the two positions other than the head is set in the range of 1 to 1000 mA.

8. The electrical signal applied to the specific position is (1) Set to repeat a cycle including a first state in which pulse waves of positive application and negative application occur alternately and a second state in which the pulse wave is paused, or (2)A first state in which a pulse wave with a constant positive or negative application is generated, a second state in which the pulse wave is in a resting state, a third state in which a pulse wave with an application opposite to the first state is generated, and a fourth state in which the pulse wave is in a resting state, are set in this order. The electrical stimulation device according to claim 1.

9. The electrical signal applied from one of the two pairs of electrode pairs and the electrical signal applied from the other pair of electrode pairs are In the electrical signal of (1) above, the time of either or both of the first state and the second state is set to be different between the two electrode pairs, or In the electrical signal of (2) above, the time of at least one of the first state, the second state, the third state, and the fourth state is set to be different between the two electrode pairs. The electrical stimulation device according to claim 8.

10. The electrical signal applied from one of the two pairs of electrode pairs and the electrical signal applied from the other pair of electrode pairs are In the electrical signal of (2) above, the application of the pulse wave in the first state is reversed between the two electrode pairs, and the application of the pulse wave in the third state is reversed between the two electrode pairs. The electrical stimulation device according to claim 8.

11. The electrical stimulation device according to claim 1, wherein the frequency of the electrical signal is set in the range of 10 to 80 pps (pulse per second).

12. The electrical stimulation device according to claim 1, which is a medical device for treating brain dysfunction.