Electrical stimulation device

Abstract

Provided is an electrical stimulation device capable of more effectively improving brain dysfunction. This electrical stimulation device is characterized by being provided with: a main body having at least two sets of channels for outputting set electrical signals 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 and that apply an electrical signal to the living body; the cable is used for connecting the at least two channels of the main body with the at least two electrodes, one of the two electrode pairs is worn at two specific positions of the right half body side, and the other electrode pair is worn at two specific positions of the left half body side, so that the brain can be electrically stimulated without passing through the brainstem; the two sets of electrode pairs are visually distinguishable from each other so as to be able to recognize the difference in use so worn, and apply electrical signals different from each other to a specific position.

Description

Technical Field

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

[0002] In Patent Document 1, as an electrical stimulation device for restoring brain dysfunction, there is described an electrical stimulation device that, in a state where electrodes are located at at least one part of the palm, back of the hand, sole, or dorsum of the foot (for example, thenar of the hand and toes), intermittently applies an electrical signal to a living body, thereby being able to stimulate the brain of the living body.

[0003] In Patent Document 2, there is described an electrical stimulation device that includes head electrodes, and in a part from the patient's neck to the top of the head, the head electrodes are worn at a specific position (for example, at least one of the temple part, the upper forehead part of the eye, the cheek part, the posterior neck part, preferably at least two places) where it is possible to apply a stimulus to the brain without passing through the brainstem. Preferably, there is also an auxiliary electrode worn at a part (for example, the back) lower than the patient's neck on the lower body side. In addition, in Patent Document 2, there is also described applying a weak current that repeats a given cycle to the head electrodes of the electrical stimulation device, setting a plurality of head electrodes or the head electrodes and the auxiliary electrodes to gradually deviate from synchronization and synchronize again at a certain period, and the like.

[0004] Prior Art Documents Patent Documents Patent Document 1: Japanese Unexamined Patent Application Publication No. 2009-153904 (Japanese Patent No. 5053826) Patent Document 2: Japanese Patent No. 5345256 Summary of the Invention

[0005] Problems to be Solved by the Invention The problem of the present invention is to provide an electrical stimulation device that can more effectively improve brain dysfunction.

[0006] Technical Means for Solving the Problems The present inventors have found that by setting the electrical signal applied from the electrical stimulation device to increase the amount of electricity, i.e., the amount of information, passing through the corpus callosum, the improvement effect of brain dysfunction can be enhanced. More specifically, as the electrodes for applying the electrical signal, a pair (a set of two) of electrodes for wearing at two locations on the right half of the body (e.g., the right head and neck) and a pair of electrodes for wearing at two locations on the left half of the body (e.g., the left head and neck) are used, and when the electrical signal applied from the electrodes for the right head and neck half of the body and the electrical signal applied from the electrodes for the left head and neck half of the body are set to be different electrical signals, it has been found that the amount of information transmitted from each of the left and right brains to the contralateral brain via the corpus callosum can be increased. Through such an increase in the amount of information via the corpus callosum, the metabolism of the nerve fibers of the corpus callosum is activated, and hypertrophy of the nerve fibers also occurs. As a result, it is considered that the improvement effect of brain dysfunction is enhanced.

[0007] That is, the present invention at least includes an invention related to the following "electrical stimulation device".

[0008] [Technical Solution 1] An electrical stimulation device, characterized by comprising: 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 detachably mounted on a living body for applying an electrical signal to the living body; and A cable for connecting at least two sets of channels of the main body to at least two sets of electrode pairs, One set of electrode pairs among the two sets of electrode pairs is worn at two specific positions on the right half of the body side, and the other set of electrode pairs is worn at two specific positions on the left half of the body side so as to be able to give electrical stimulation to the brain without passing through the brainstem. The two sets of electrode pairs can be visually distinguished from each other so as to be able to identify the difference in the purpose of such wearing, and different electrical signals are applied to the specific positions.

[0009] [Technical Solution 2] The electrical stimulation device according to Technical Solution 1, wherein the specific positions include two locations on the head and neck selected from the temple area, the upper forehead area of the eyes, the cheek area, and the posterior neck area.

[0010] [Technical Solution 3] The electrical stimulation device according to Technical Solution 2, wherein in a head-mounted wearing member covering the head of the wearer, the two sets of electrode pairs are pre-configured at positions corresponding to the two specific positions including the head and neck.

[0011] [Technical Solution 4] The electrical stimulation device according to Technical Solution 2 or 3, wherein the current value of the electrical signal applied to the specific positions at two places including the head and neck is set within the range of 1 to 1000 μ A.

[0012] [Technical Solution 5] The electrical stimulation device according to any one of Technical Solutions 1 to 4, wherein the specific positions include two places other than the head and neck, and the two places other than the head and neck are selected from the parts from the palm to the back of the hand, the parts from the sole to the back of the foot, and the parts of the back along the spinal cord.

[0013] [Technical Solution 6] The electrical stimulation device according to Technical Solution 5, wherein in the semi-glove-shaped or semi-sock-shaped wearing member worn on the hand or foot of the wearer, the two sets of electrode pairs are pre-configured at positions corresponding to the specific positions including the two places other than the head and neck.

[0014] [Technical Solution 7] The electrical stimulation device according to Technical Solution 5 or 6, wherein the current value of the electrical signal applied to the specific positions including the two places other than the head and neck is set within the range of 1 to 1000 mA.

[0015] [Technical Solution 8] The electrical stimulation device according to any one of Technical Solutions 1 to 7, wherein, (1) The electrical signal applied to the specific position is set to repeatedly perform a cycle including a first state in which a pulse wave including alternately generating a positive application and a negative application and a second state in which the pulse wave is in a rest state; or (2) The electrical signal applied to the specific position is set to sequentially include a first state in which a pulse wave always generating a positive application or a negative application, a second state in which the pulse wave is in a rest state, a third state in which a pulse wave generating an application opposite to the first state, and a fourth state in which the pulse wave is in a rest state.

[0016] [Technical Solution 9] The electrical stimulation device according to Technical Solution 8, wherein, Regarding the electrical signal applied from one set of electrode pairs among the two sets of electrode pairs and the electrical signal applied from the other set of electrode pairs, in the electrical signal of (1), the time of either one or both of the first state and the second state is set to be different between the two electrodes; or Regarding the electrical signal applied from one set of electrode pairs among the two sets of electrode pairs and the electrical signal applied from the other set of electrode pairs, in the electrical signal of (2), the time of at least one state among the first state, the second state, the third state, and the fourth state is set to be different between the two electrodes.

[0017] [Technical Solution 10] The electrical stimulation device according to Technical Solution 8, wherein, Regarding the electrical signals applied from one of the two pairs of electrodes and the electrical signals applied from the other pair of electrodes, in the electrical signals of (2), the application of the pulse wave in the first state is opposite between the two electrodes, and the application of the pulse wave in the fourth state is opposite between the two electrodes.

[0018] [Technical Solution 11] The electrical stimulation device according to any one of Technical Solutions 1 to 10, wherein the frequency of the electrical signal is set within the range of 10 to 80 pps (pulses per second).

[0019] [Technical Solution 12] The electrical stimulation device according to any one of Technical Solutions 1 to 11, wherein the electrical stimulation device is a medical device for treating brain dysfunction.

[0020] In addition, the invention related to the above-mentioned "electrical stimulation device" can be converted into an invention related to an "electrical stimulation method". That is, the present invention also includes an invention related to the following "electrical stimulation method". Modification [Technical Solution 1'] An electrical stimulation method, characterized in that at least two pairs of electrodes are used, One of the two pairs of electrodes is worn at two specific positions on the right half of the body, and the other pair of electrodes is worn at two specific positions on the left half of the body, so as to be able to electrically stimulate the brain without passing through the brainstem, and Different electrical signals are applied to the specific positions by the two pairs of electrodes.

[0021] [Technical Solution 1A'] The electrical stimulation method according to Technical Solution 1', wherein, The two pairs of electrodes are included in an electrical stimulation device, and the electrical stimulation device includes: A main body having at least two channels for outputting the set electrical signals from a positive electrode output part and a negative electrode output part; A cable for connecting at least two channels of the main body to at least two pairs of electrodes; and At least two pairs of electrodes detachably mounted on a living body for applying electrical signals to the living body.

[0022] [Technical Solution 1B'] The electrical stimulation method according to Technical Solution 1' or 1A', wherein the two pairs of electrodes can be visually distinguished from each other so as to be able to identify different uses of wearing.

[0023] [Technical Solution 2'] The electrostimulation method according to Technical Solution 1', 1A' or 1B', wherein the specific positions include two positions on the head and neck, and the two positions on the head and neck are selected from the temple area, the upper forehead area of the eyes, the cheek area, and the posterior neck area.

[0024] [Technical Solution 3'] The electrostimulation method according to Technical Solution 2', wherein the two sets of electrode pairs are arranged at positions corresponding to the specific positions including the two positions on the head and neck through a head-mounted wearable covering the head of the wearer.

[0025] [Technical Solution 4'] The electrostimulation method according to Technical Solution 2' or 3', wherein the current value of the electrical signal applied to the specific positions including the two positions on the head and neck is set within the range of 1 to 1000 μ A.

[0026] [Technical Solution 5'] The electrostimulation method according to Technical Solutions 1' to 4', wherein the specific positions include two positions other than the head and neck, and the two positions other than the head and neck are selected from the area from the palm to the back of the hand, the area from the sole to the instep, and the area of the back along the spinal cord.

[0027] [Technical Solution 6'] The electrostimulation method according to Technical Solution 5', wherein in a semi-glove-shaped or semi-sock-shaped wearable worn on the hand or foot of the wearer, the two sets of electrode pairs are pre-arranged at positions corresponding to the specific positions including the two positions other than the head and neck.

[0028] [Technical Solution 7'] The electrostimulation method according to Technical Solution 5' or 6', wherein the current value of the electrical signal applied to the specific positions including the two positions other than the head and neck is set within the range of 1 to 1000 mA.

[0029] [Technical Solution 8'] The electrostimulation method according to any one of Technical Solutions 1' to 7', wherein, (1) The electrical signal applied to the specific position is set to repeatedly perform a cycle including a first state of generating a pulse wave with alternating positive application and negative application and a second state of pulse wave rest; or (2) The electrical signal applied to the specific position is set to sequentially include a first state of always generating a pulse wave with positive application or negative application, a second state of pulse wave rest, a third state of generating a pulse wave with an application opposite to the first state, and a fourth state of pulse wave rest.

[0030] [Technical Solution 9'] The electrical stimulation method according to Technical Solution 8', wherein, Regarding the electrical signals applied from one of the two pairs of electrodes and the electrical signals applied from the other pair of electrodes, in the electrical signals 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 electrodes; or Regarding the electrical signals applied from one of the two pairs of electrodes and the electrical signals applied from the other pair of electrodes, in the electrical signals 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 electrodes.

[0031] [Technical Solution 10'] The electrical stimulation method according to Technical Solution 8', wherein, Regarding the electrical signals applied from one of the two pairs of electrodes and the electrical signals applied from the other pair of electrodes, in the electrical signals of (2) above, the application of the pulse wave in the first state is set to be opposite between the two electrodes, and the application of the pulse wave in the fourth state is set to be opposite between the two electrodes.

[0032] [Technical Solution 11'] The electrical stimulation method according to any one of Technical Solutions 1' to 10', wherein the frequency of the electrical signal is set within the range of 10 to 80 pps (pulses per second).

[0033] [Technical Solution 12'] The electrical stimulation method according to any one of Technical Solutions 1' to 11' is used for treating brain dysfunction.

[0034] Advantages of the Invention By using the electrical stimulation device of the present invention, an improvement method for brain dysfunction with further improved effects can be implemented. For example, it is also possible to improve the IQ of children with intellectual disabilities.

[0035] It should be noted that, compared with the electrical stimulation device described in Patent Document 2, the electrical stimulation device described in Patent Document 1 that applies stimulation to the peripheral nerves can more effectively improve brain function by more effectively applying stimulation to the brain. However, the electrical stimulation devices described in these patent documents are electrical stimulation devices for wearing one electrode of a pair of electrodes on the right half of the body and the other electrode on the left half of the body at the hand or foot in Patent Document 1 and at the part from the neck to the top of the head in Patent Document 2, that is, a pair of left and right electrical stimulation devices. In such a case of use, the electrical stimulation applied from one electrode (for example, the right half of the body) is sent from one side of the brain (for example, the right brain) to the contralateral brain (for example, the left brain) via the corpus callosum and flows to the other electrode (for example, the left half of the body). In the present invention, the information transmission via the corpus callosum is different from the information transmission in such prior art, and the amount of information passing through the corpus callosum can be further increased, so that an effect different from that of the prior art can be achieved. Description of the Drawings

[0036] Figure 1 It is a simplified perspective view of an example of the electrical stimulation device of the present invention.

[0037] Figure 2 It is a schematic diagram of an embodiment of the present invention (the first embodiment of electrical stimulation). a to d represent the lengths of the first state, the second state, the third state, and the fourth state under the electrical stimulation applied by the first electrode pair connected to the first channel (Ch1), and a' to d' represent the lengths of the first state, the second state, the third state, and the fourth state under the electrical stimulation applied by the second electrode pair connected to the second channel (Ch2). In this embodiment, a = a', c = c', but since b ≠ b', d ≠ d', the applied electrical stimulation (pulse wave) has a deviation (non-synchronization). In addition, h1 and h2 represent the current values of the pulse waves in the first state and the second state under the electrical stimulation applied by the first electrode pair, and h1' and h2' represent the current values of the pulse waves in the first state and the third state under the electrical stimulation applied by the second electrode pair. In this embodiment, h1 = h2, h1' = h2'.

[0038] Figure 3 It is a schematic diagram of an embodiment of the present invention (the second embodiment of electrical stimulation). a to d, h1 and h2, and a' to d', h1' and h2' are the same as Figure 2 However, regarding the pulse wave in the first state under the electrical stimulation applied by the first electrode pair and the pulse wave in the first state under the electrical stimulation applied by the second electrode pair, their positive and negative are opposite. Regarding the pulse wave in the third state under the electrical stimulation applied by the first electrode pair and the pulse wave in the third state under the electrical stimulation applied by the second electrode pair, their negative and positive are also opposite. Therefore, the applied electrical stimulation (pulse wave) is completely out of sync.

[0039] Symbolic Explanation 1 Electrical Stimulation Device 10 Main Body 11 First Channel (a set of channels) 11a First Output Part of the First Channel 11b Second Output Part of the First Channel 12 Second Channel (a set of channels) 12a First Output Part of the Second Channel 12b Second Output Part of the Second Channel 21 First Electrode Pair (a set of electrode pairs) 21a First Electrode of the First Electrode Pair 21b Second Electrode of the First Electrode Pair 31a First Cable of the First Electrode Pair 31b Second Cable of the First Electrode Pair 41a First Terminal of the First Electrode Pair 41b Second Terminal of the First Electrode Pair 22 Second Electrode Pair (a set of electrode pairs) 22a First Electrode of the Second Electrode Pair 22b Second Electrode of the Second Electrode Pair 32a First Cable of the Second Electrode Pair 32b Second Cable of the Second Electrode Pair 42a First Terminal of the Second Electrode Pair 42b Second Terminal of the Second Electrode Pair. Detailed Embodiment

[0040] - Electrical Stimulation Device - The electrical stimulation device of the present invention is characterized in that it comprises: 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 detachably mounted on a living body for applying an electrical signal to the living body; and a cable for connecting at least two channels of the main body to at least two electrodes. One set of electrode pairs of the two sets of electrode pairs is worn at two specific positions on the right half side of the body, and the other set of electrode pairs is worn at two specific positions on the left half side of the body, so as to be able to apply electrical stimulation to the brain without passing through the brainstem. The two sets of electrode pairs can be visually distinguished from each other so as to be able to identify the different uses of such wearing, and different electrical signals are applied to specific positions.

[0041] Hereinafter, the embodiments of the present invention will be described more specifically with reference to the drawings. Figure 1 A simplified perspective view showing an example of the electrical stimulation device of the present invention.

[0042] The electrical stimulation device 1 includes: a main body 10, two pairs of electrodes, and cables. Among them, the main body 10 outputs a set electrical signal; the two pairs of electrodes and cables are: a first pair of electrodes 21 (electrode 21a and electrode 21b) and a cable 31 connecting the first pair of electrodes 21 to the main body 10 (cable 31a and cable 31b, each including a terminal part 41a and a terminal part 41b), and a second pair of electrodes 22 (electrode 22a and electrode 22b) and a cable 32 connecting the second pair of electrodes 22 to the main body 10 (cable 32a and cable 32b, each including a terminal part 42a and a terminal part 42b). It should be noted that inside the main body 10, there is a circuit (not shown) connected to the output part for generating the set electrical signal.

[0043] The main body 10 has a total of eight groups of channels, with two output parts forming a set (a pair), namely a first channel 11 (output part 11a and output part 11b), a second channel 12 (output part 12a and output part 12b), a third channel 13... an eighth channel 18. Figure 1 In the illustrated embodiment, the main body 1 has a total of eight groups of channels, but as long as it has at least two groups of channels so that the first pair of electrodes 21 (electrode 21a and electrode 21b) and the second pair of electrodes 22 (electrode 22a and electrode 22b) can be respectively connected to a group of channels. In each channel, one output part becomes the positive electrode output part and the other output part becomes the negative electrode output part. For example, in the first channel 11, the output part 11a can be set as the positive electrode output part and the output part 11b can be set as the negative electrode output part.

[0044] Regarding the electrodes, two electrodes form a set (a pair). The electrodes 21a, 21b, 22a, and 22b become positive electrodes when connected to the positive electrode output parts of the respective channels of the main body 10 via their respective cables and terminal parts, and become negative electrodes when connected to the negative electrode output parts. The positively applied electrical signal (pulse wave) flows in the living body from the positive electrode connected to the positive electrode output part towards the negative electrode connected to the negative electrode output part, and conversely, the negatively applied electrical signal flows in the living body from the negative electrode connected to the negative electrode output part towards the positive electrode connected to the positive electrode output part. The electrical signals of each channel can be independently controlled based on a program.

[0045] In the present invention, as described in other records, the electrical signals (pulse waves) applied to the living body from one set (the first pair of electrodes) and the other set (the second pair of electrodes) of the two pairs of electrodes have mutually different waveforms, but the electrical signals themselves applied to the living body from each pair of electrodes, that is, the electrical signals output from the respective channels of the main body 10 connected to these respective pairs of electrodes, can follow the conventional electrical signals.

[0046] The electrical signal (pulse wave) applied to the living body can be set, for example, to repeat a cycle including a state of generating a pulse wave (referred to as "pulse wave generation state" in this specification) and a state of pulse wave rest (referred to as "pulse wave rest state" in this specification).

[0047] In the pulse wave generation state, the frequency of the pulse wave is generally adjusted within the range of 10 to 80 pps (pulse per second), and as an example, it can be set to 50 pps. In order for the brain to perceive one pulse, the frequency is generally 80 pps or less, preferably 60 pps or less. On the other hand, if the frequency is too small, it is difficult to give a sufficient number of stimulations, so the frequency is generally 10 pps or more, preferably 20 pps or more.

[0048] In addition, in the pulse wave generation state, the current value of the pulse wave can be constant, can increase gradually, or can decrease gradually. For example, the state of generating a pulse wave can also be composed of a state where the current value of the pulse wave increases gradually and a subsequent state where the pulse wave is constant. By including the state where the current value of the pulse wave increases gradually, it is possible to prevent a sharp electrical stimulation from being applied to the brain.

[0049] The current value of the pulse wave can be appropriately adjusted according to the embodiments of the present invention so that an appropriate current flows through the living body. For example, in the case of including two locations in the head and neck (described in detail later), the current value of the pulse wave is generally adjusted within the range of 1 to 1000 μ A, and as an example, it can be set to 40 μ A. In order to avoid the stimulation to the brain becoming too large, the current value is preferably 100 μ A or less, more preferably 80 μ A or less. On the contrary, if the current value is too small, the brain cannot perceive it, so the current value is preferably 10 μ A or more, more preferably 20 μ A or more. In addition, in the case of including two locations other than the head and neck (hands, feet, back, etc., described in detail later), the current value of the pulse wave can generally be adjusted within the range of 1 to 1000 mA, for example, 10 to 500 mA, preferably 30 to 300 mA.

[0050] The pulse wave generation state, the pulse wave rest state, the state where the current value is constant, the increasing state, and the decreasing state in the pulse wave generation state, and the time for repeating the cycle can be appropriately adjusted respectively. For example, the pulse wave generation state and the pulse wave rest state can be adjusted between 2 and 9 seconds respectively. In addition, from the viewpoint of preventing fatigue to the brain, the time of the pulse wave rest state is preferably the same as or longer than the time of the pulse wave generation state, and can also be set to 2 times or more, for example.

[0051] In one embodiment of the present invention (the first embodiment of the pulse wave), the electrical signal applied to the living body can be set to repeat a cycle including a first state in which a pulse wave including alternately generating a positive application and a negative application and a second state in which the pulse wave is at rest. The time of each of the first state and the second state in this embodiment can be adjusted, for example, between 2 and 9 seconds respectively.

[0052] In one embodiment of the present invention (the second embodiment of the pulse wave), the electrical signal applied to the living body can be set to sequentially include a first state in which a pulse wave of positive application or negative application is always generated, a second state in which the pulse wave is at rest, a third state in which a pulse wave of an application opposite to the first state is generated, and a fourth state in which the pulse wave is at rest. The current value of the pulse wave of positive application or negative application in the first state and the current value of the pulse wave of the opposite application in the third state can also be set to be the same. The time of each of the first state to the fourth state can be appropriately adjusted, for example, between 2 and 9 seconds respectively.

[0053] The first electrode pair 21 (electrode 21a and electrode 21b) and the second electrode pair 22 (electrode 22a and electrode 22b) are used to be respectively worn at two specific positions on the right half side of the body and two specific positions on the left half side of the body where electrical stimulation can be given to the brain without passing through the brainstem. Any one of electrode 21a and electrode 21b in the first electrode pair 21 and any one of electrode 22a and electrode 22b in the second electrode pair 22 are used to be worn at two specific positions in the right half of the body, and the other is used to be worn at two specific positions in the left half of the body.

[0054] In one embodiment of the present invention, from the viewpoint of not being reduced in stimulation by the brainstem barrier via the peripheral nerve, the specific positions can include two parts located between the neck and the top of the head (referred to as "head and neck" in this specification). For example, two specific parts of one of the two sets of electrode pairs can be set to be two parts on the right half side of the head and neck (referred to as "right head and neck" in this specification), and two specific parts of the other set can be set to be two parts on the left half side (referred to as "left head and neck" in this specification). As the specific positions of the right head and neck and the left head and neck respectively, for example, two parts selected from the temple part, the upper forehead part of the eye, the cheek part, and the back of the neck are preferred. As an example, the following embodiment can be cited: electrode 21a in the first electrode pair is worn at the temple part of the right head and neck, electrode 21b is worn at the back of the neck part of the right head and neck, electrode 22a in the second electrode pair is worn at the temple part of the left head and neck, and electrode 22b is worn at the back of the neck part of the left head and neck.

[0055] In one embodiment of the present invention, in addition to the head and neck, specific positions can include, for example, two positions in a part lower than the neck, such as the part from the palm to the back of the hand (fingertips, thenar eminence, phalanges, etc.), the part from the sole of the foot to the instep, and the part of the back along the spinal cord. For example, one of the specific positions of one of the two electrode pairs can be set to two positions on the right half of the body excluding the head and neck, and the specific positions of the other group can be set to two positions on the left half of the body excluding the head and neck. Alternatively, one of the specific positions of one of the two electrode pairs can be set to two positions on the head and neck (e.g., the right half of the body), and the specific positions of the other group can be set to two positions outside the head and neck (e.g., the left half of the body).

[0056] In one embodiment of the present invention, the specific position can also be set to the following combination: including at least two positions on the head and neck, such as two positions on the right head and neck and two positions on the left head and neck, and additionally including at least two positions outside the head and neck, such as two positions on the right half of the body below the neck and two positions on the left half of the body. In an embodiment of such a combination, the electrical stimulation device can, for example, include the first electrode pair 21 and the second electrode pair 22 as electrode pairs for the right head and neck and the left head and neck, respectively, and additionally include the third electrode pair (not shown) and the fourth electrode pair (not shown) as electrode pairs for the right half of the body and the left half of the body outside the head and neck, respectively.

[0057] The electrodes (21a and 21b) of the first electrode pair 22 and the second electrode pair 22 (electrodes 22a and 22b) can be distinguished from each other so that the use of one for the right half of the body and the other for the left half of the body can be identified. Thus, for example, it is easy to avoid confusing the combination of the electrode 21a constituting the first electrode pair and the electrode 22b constituting the second electrode pair with a pair of electrodes, and it is possible to more reliably wear both the first electrode pair 21a and 21b at specific positions on the right half or the left half of the body, and wear both the second electrode pair 22a and 22b at specific positions on the opposite side. It should be noted that the third electrode pair and the fourth electrode pair, or other electrode pairs, exemplified as auxiliary electrode pairs in the above embodiment can also be visually distinguished from each other so that the use of one for the right half of the body and the other for the left half of the body can be identified.

[0058] The means for "being able to be distinguished from each other" are not particularly limited, and various well-known means can be used. For example, means that can be visually distinguished, such as distinguishing by color, pasting labels with characters or marks, and making the shapes of the electrodes different, can be cited. It should be noted that the electrodes can also be combined so that the cables (including the terminal parts) and / or channels can also be visually distinguished. For example, it can be cited that the first electrode pair 22 (electrode 21a and electrode 21b), the cables 31a and 31b as needed, and the first channel 11 (output part 11a and output part 11b) connecting them are colored red, or marked with characters such as "right". On the other hand, the second electrode pair 22 (electrode 22a and electrode 22b), the cables 32a and 32b as needed, and the second channel 12 (output part 12a and output part 12b) connecting them are colored blue, or marked with characters such as "left". In addition, pre-configuring electrodes in a wearable device as described later also corresponds to the means for "being able to be distinguished from each other".

[0059] The properties (material, shape, etc.) of each electrode are not particularly limited as long as they can be detached from and attached to the living body. For example, it can be a pad-shaped electrode (gel electrode pad) formed of a gel-like member. In addition, the electrodes for wearing on the right head and neck and the left head and neck, and the electrodes arranged on the wearable device can be in a sheet shape, and the electrodes for wearing on the right half body and the left half body other than the head and neck (for example, the auxiliary electrodes in the embodiments described later), and the electrodes that are not arranged on the wearable device can be in a suction cup shape.

[0060] In the present invention, the first electrode pair and the second electrode pair apply different electrical signals to specific positions. Typically, the first channel 11 (output part 11a and output part 11b) and the second channel 12 (output part 12a and output part 12b) connected to the first electrode pair 21 (electrode 21a and electrode 21b) and the second electrode pair 22 (electrode 22a and electrode 22b) via cables output electrical signals with different waveforms, and thus it can be set as described above. On the other hand, by making the specific positions where the first electrode pair 21a and 21b are worn different from (for example, opposite to) the specific positions where the second electrode pair 22a and 22b are worn, it can also be set as described above.

[0061] The "electrical signals with different waveforms" are not particularly limited as long as the amount of information transmitted from each of the left and right brains to the opposite brain via the corpus callosum can be increased compared with the electrical signals of the same waveform.

[0062] In an embodiment of the present invention (the first embodiment of electrical stimulation), the electrical signals (pulse waves) of the first electrode pair 21 and the electrical signals (pulse waves) of the second electrode pair 22 are set to be different in at least one of the pulse wave generation state and the pulse wave rest state.

[0063] For example, in the first embodiment of electrical stimulation, as an example of making the time of either or both of the first state (pulse wave generation state) and the second state (pulse wave rest state) of the pulse wave of the present invention different, the lengths of the first state are made equal in both electrode pairs (for example: both are set to 3 seconds). On the other hand, the lengths of the second state are made different from each other (for example: set to 3 seconds in the first electrode pair and 5 seconds in the second electrode pair). In addition, in the first embodiment of electrical stimulation, as an example of making at least one of the time of the first state and the third state (pulse wave generation state) and the time of the second state and the fourth state (pulse wave rest state) of the second embodiment of the pulse wave of the present invention different, the lengths of the first state and the third state can be made equal in both electrode pairs. On the other hand, the lengths of the second state and the fourth state can be made different from each other (the lengths of the second state and the fourth state in each electrode pair are made equal).

[0064] As Figure 2 shown, in the first embodiment of electrical stimulation, by setting as described above, a deviation (asynchrony) occurs in the timing of generating the pulse wave between the first electrode pair and the second electrode pair. That is, regarding the electrical stimulation of the left and right brains, even if the magnitude of the current value of the pulse wave is the same and the vector of the electrical stimulation is also in the same direction, the timing will gradually deviate. Since the left and right brains send such information to the contralateral brain, the necessity of information exchange via the corpus callosum is increased. As a result, the metabolism of the nerve fibers of the corpus callosum is activated, leading to the hypertrophy of the nerve fibers and the formation of new nerve tissues, thereby being able to more effectively improve brain dysfunction. It should be noted that in each cycle, when the times of multiple states of the pulse wave generation state and the pulse wave rest state are set to be different, the time of the whole cycle may be equal, but it is preferably set that the time of the whole cycle is also different. It should be noted that even if the pulse wave deviates between the first electrode pair and the second electrode pair and becomes asynchronous, after a certain time, the moment when the pulse waves finally coincide and become synchronous will come, and then they will become asynchronous again and return to synchronization, repeating such a cycle.

[0065] In another embodiment of the present invention (the second embodiment of electrical stimulation), the electrical signals (pulse waves) of the first electrode pair 21 and the electrical signals (pulse waves) of the second electrode pair are set such that the application of the pulse waves in the pulse wave generation state is opposite to each other.

[0066] For example, in the second embodiment of the electrical stimulation, the application of the pulse wave in the first state and the third state in the second embodiment of the pulse wave of the present invention is set to be opposite to each other between the two electrode pairs. As an example, it can be set that the first state under the electrical signal of the first electrode pair 21 is positive application, the first state under the electrical signal of the second electrode pair 22 is negative application, the third state under the electrical signal of the first electrode pair 21 is negative application, and the third state under the electrical signal of the second electrode pair 22 is positive application. It should be noted that the lengths of the respective times of the first state and the third state (pulse wave generation state), and the lengths of the respective times of the second state and the fourth state (pulse wave rest state) may be the same between the two electrode pairs.

[0067] As Figure 3 shown, in the second embodiment of the electrical stimulation, by setting as described above, the vectors of the electrical stimulation become opposite directions, and the electrical stimulation of the left and right brains is independent. As an example, a positive pulse wave is applied by the first electrode pair 21, and the electrical stimulation flows from the electrode 21a (positive electrode) worn on the right temple to the electrode 21b (negative electrode) worn on the right posterior neck. In contrast, a negative pulse wave is applied in the second electrode pair 22, and the electrical stimulation flows from the electrode 22a (negative electrode) worn on the left posterior neck to the electrode 22b (positive electrode) worn on the left temple. Therefore, the left and right brains send information different from that of the first embodiment of the electrical signal to the contralateral brain. In this case, the necessity of information exchange via the corpus callosum is also different from that of the first embodiment. Therefore, in addition to causing hypertrophy of nerve fibers and the formation of new nerve-like organisms, it also causes the formation of new nerve products not brought about in the first embodiment, and can more effectively improve brain dysfunction.

[0068] In one embodiment of the present invention, it may also be that the two electrode pairs are pre-configured at positions corresponding to specific positions in a head-mounted wearing member covering the head of the wearer. In this embodiment, by the wearer wearing the head-mounted wearing member on the head and neck, a set of electrode pairs (for example, the first electrode pair) can be naturally arranged on the right head and neck side, and the other set of electrode pairs (for example, the second electrode pair) can be arranged on the left head and neck side. Therefore, it is suitable for the embodiment of wearing two sets of electrode pairs at specific parts (for example, two of the temple part, the upper forehead part of the eyes, the cheek part, or the posterior neck part) located on the left and right head and neck.

[0069] The head-mounted wearing member is formed to be able to expand and contract significantly, for example, by an elastic sheet. Specifically, the head-mounted wearing member has a bag-shaped main body portion that can cover from the wearer's head to the neck. The front side of the main body portion (the side facing the patient's face) can be formed to expose the wearer's eyes, nose, and mouth. The main body portion covers the top of the wearer's head, the left and right side faces, and the back of the head (including the upper part of the neck). On the inner surface of the wearing member, at positions corresponding to specific positions on the head and neck, two sets of electrode pairs are arranged in a fixed or detachable manner (for example, using a hook-and-loop fastener). In addition, a pair of left and right extending portions can be provided on the main body portion, extending from a position slightly below the wearer's eyes toward the nose. And by providing an elastic cord that connects the pair of left and right extending portions to each other and an elastic cord that connects the front lower end portions of the main body portion to each other, each electrode pair can be reliably worn at a specific position in the state of covering the wearing member. It is also possible to hold a thin elastic plate in the extending portion, and by using the elastic force of the elastic plate, the extending portion can be reliably attached to the wearer's cheek portion. It should be noted that those skilled in the art can appropriately design other matters related to the head-mounted wearing member in the present invention by referring to known head-mounted wearing members.

[0070] In an embodiment of the present invention, it may also be that two sets of electrode pairs are pre-arranged at positions corresponding to specific positions in a semi-glove-shaped or semi-sock-shaped wearing member worn on the wearer's hand or foot. In this embodiment, by the wearer wearing the wearing member on the hand or foot, one set of electrode pairs (for example, the third electrode pair) can be naturally arranged on the right half body side except for the head and neck, and the other set of electrode pairs (for example, the fourth electrode pair) can be arranged on the left half body side except for the head and neck. Therefore, it is suitable for an embodiment in which two sets of electrode pairs are worn at specific parts on the left and right except for the left and right head and necks.

[0071] For example, the semi-glove-shaped wearing member has a main body portion formed of a material having stretchability or elasticity and capable of being put on the wearer's hand. The semi-glove-shaped wearing member may also have a fastening device such as a fastener or a hook-and-loop fastener for taking off and putting on from the hand. In this case, it may not necessarily be formed of a stretchable raw material. On the inner surface of the semi-glove-shaped wearing member (main body portion), two sets of electrode pairs are arranged at positions corresponding to parts of specific positions on the hand (palm or back of the hand). For example, on the inner surface of the semi-glove-shaped wearing member (main body portion) for the right hand and the left hand respectively, one set of electrode pairs is arranged at positions corresponding to the thenar (first specific part) and the fingertips (second specific part). It should be noted that for other matters related to the semi-glove-shaped or semi-sock-shaped wearing member in the present invention, those skilled in the art can appropriately design by referring to known semi-glove-shaped or semi-sock-shaped wearing members.

[0072] <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. It should be noted that in this specification, "treatment" means including completely or partially treating brain dysfunction, completely or partially curing (alleviating or improving) the symptoms associated with brain dysfunction, decelerating, delaying or preventing the progression of brain dysfunction or its symptoms, reducing the risk of occurrence, or a combination thereof. The treatment can be non-clinical trials, pre-clinical experiments or clinical trials.

[0073] As brain dysfunctions that can be treated using the electrical stimulation device of the present invention and that can, for example, have an improvement effect, the following brain dysfunctions can be cited: As organic mental disorders including symptomatic ones, the following can be cited: mental diseases caused by severe (i.e., macroscopic) lesions of the brain such as dementing diseases, Korsakoff syndrome, sequelae of head trauma, etc.; As mental and behavioral disorders caused by the use of psychoactive substances, the following can be cited: mental diseases related to psychoactive substances such as alcohol, opium, cannabis, sedatives or hypnotics, cocaine, stimulants / caffeine, hallucinogens, tobacco, volatile solvents, sugar, etc. (which can be classified into dependence, abuse, intoxication, etc.), alcohol dependence, drug dependence, etc.; As schizophrenia, schizophreniform disorders and delusional disorders, the following can be cited: schizophrenia, schizophreniform disorders, persistent delusional disorder, acute transient psychotic disorder, induced delusional disorder, schizoaffective disorder; As mood disorders (also known as affective disorders, mainly mood disorders with negative impacts on mood), the following can be cited: mania, bipolar disorder (manic-depressive illness), depression; As neurotic disorders, stress-related disorders, and somatoform disorders, the following can be cited: phobic anxiety disorders (agoraphobia, social phobia), other anxiety disorders (panic disorder, generalized anxiety disorder), obsessive-compulsive disorder, acute stress disorder, reactions to severe stress and adjustment disorders (PTSD and acute stress disorder are included in anxiety disorders in DSM-IV (the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders), but are classified as severe stress reactions in ICD-10 (the 10th revised edition of the International Statistical Classification of Diseases and Related Health Problems)), acute stress disorder, PTSD (post-traumatic stress disorder), adjustment disorder, dissociative (conversion) disorders (F44), dissociative disorders (dissociative disorders roughly correspond in DSM-IV-TR (the Diagnostic and Statistical Manual of Mental Disorders)), other dissociative (conversion) disorders, multiple personality disorder (dissociative identity disorder in DSM-IV-TR (the Diagnostic and Statistical Manual of Mental Disorders)), somatoform disorders (somatization disorder, hypochondriasis, persistent somatoform pain disorder), other neurotic disorders; As behavioral syndromes related to physical disorders and physical factors, the following can be cited: eating disorders, anorexia nervosa (anorexia), bulimia nervosa (binge eating disorder), sleep disorders, insomnia, psychophysiological insomnia (circadian rhythm sleep disorder, difficulty falling asleep, middle-of-the-night awakening, early morning awakening, hypersomnia, sleep apnea syndrome, narcolepsy, primary hypersomnia, recurrent hypersomnia, idiopathic hypersomnia), sleep inversion, REM sleep behavior disorder, sleepwalking, sleep terrors; As personality and behavioral disorders, the following can be cited: paranoid personality disorder, schizotypal personality disorder, antisocial personality disorder, emotionally unstable personality disorder (impulsive and borderline types), histrionic personality disorder, obsessive-compulsive personality disorder, avoidant [anxious] personality disorder, dependent personality disorder, other (or undetermined or mixed) personality disorders, persistent personality change, personality and behavioral disorders not due to brain injury and brain disease, habits and impulse disorders, gender identity disorder, sexual preference disorders (fetishism, exhibitionism, voyeurism, pedophilia, sadomasochism), psychological and behavioral disorders related to sexual development and orientation, other adult personality and behavioral disorders, intentional feigning of symptoms or impairment of ability, physical or psychological personality and behavioral disorders (factitious disorder), Münchausen syndrome; As mental retardation, the following can be cited: intellectual disability; As psychological development disorders, the following can be cited: pervasive developmental disorders, autism, Asperger syndrome; As behavioral and emotional disorders that usually occur in childhood and adolescence, there are attention-deficit / hyperactivity disorder (ADHD) (tic disorders, Tourette disorder); As other obstacles, there are hallucinations, delusions, and culture-bound syndromes (nervousness, social phobia).

[0074] - Electrical stimulation method - The electrical stimulation method of the present invention is characterized in that at least two pairs of electrodes are used. Among them, one pair of electrodes in the two pairs of electrodes is worn at two specific positions on the right half of the body, and the other pair of electrodes is worn at two specific positions on the left half of the body, so as to be able to electrically stimulate the brain without passing through the brainstem, and different electrical signals are applied to the specific positions through the two pairs of electrodes. Alternatively, the two pairs of electrodes are included in an electrical stimulation device, and the electrical stimulation device includes: a main body having at least two channels for outputting a set electrical signal from a positive electrode output part and a negative electrode output part; a cable for connecting at least two channels of the main body to at least two pairs of electrodes; and at least two pairs of electrodes detachably mounted on a living body for applying an electrical signal to the living body. In addition, the two pairs of electrodes can be visually distinguished from each other so as to be able to identify different uses of wearing. The electrical stimulation method of the present invention can be implemented for treating (improving) brain dysfunction.

[0075] In this specification, the technical matters related to the electrical stimulation method can be applied to the technical matters related to the electrical stimulation device described above. For example, the preferred embodiments related to the electrical stimulation device can be converted into the preferred embodiments related to the electrical stimulation method. Conversely, in this specification, the technical matters related to the electrical stimulation method can also be applied to the technical matters related to the electrical stimulation device.

[0076] Examples [Example 1] UH male, 5 years and 7 months old A patient diagnosed with autism. From December 12, 2014 (Heisei 26) to August 31, 2015 (Heisei 27), treatment was carried out using the electrical stimulation device of the present invention. The electrical stimulation device is a head-mounted wearable device equipped with electrodes for applying electrical stimulation to the respective temple parts and the back of the neck on the left and right (the same applies to Example 2 below). The treatment frequency is 1 - 3 days / week. The IQ was 58 before treatment, but rose to 67 after treatment.

[0077] [Example 2] YF male, 11 years and 9 months old A patient diagnosed with undetermined late-life developmental disorder. From May 26, 2013 (Heisei 25) to June 10, 2016 (Heisei 28), treatment was carried out using the electrical stimulation device of the present invention. The treatment frequency is 1 - 5 days / week. The IQ was 74 before treatment, but rose to 92 after treatment.

Claims

1. An electrical stimulation device, characterized in that, Comprising: a main body having at least two sets of channels for outputting a set electrical signal from a positive output portion and a negative output portion; at least two sets of electrode pairs detachably mounted on a living body for applying an electrical signal to the living body; and a cable for connecting at least two sets of channels of the main body to at least two sets of electrode pairs, one of the two sets of electrode pairs is worn at two specific positions on the right half side of the body, and the other set of electrode pairs is worn at two specific positions on the left half side of the body so as to be able to electrically stimulate the brain without passing through the brainstem. The two sets of electrode pairs can be visually distinguished from each other so as to be able to identify the different uses of such wearing, and different electrical signals are applied to the specific positions.

2. The electrical stimulation device according to claim 1, wherein the specific positions include two positions on the head and neck, and the two positions on the head and neck are selected from the temple area, the upper forehead area of the eyes, the cheek area, and the back of the neck area.

3. The electrical stimulation device according to claim 2, wherein in a head-mounted wearing member covering the head of the wearer, the two sets of electrode pairs are pre-configured at positions corresponding to the two specific positions including the head and neck.

4. The electrical stimulation device according to claim 2, wherein The current value of the electrical signal applied to specific positions at two locations including the head and neck is set within the range of 1 to 1000 μ A.

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

6. The electrical stimulation device according to claim 5, wherein in a semi-glove-shaped or semi-sock-shaped wearing member worn on the hand or foot of the wearer, the two sets of electrode pairs are pre-configured at positions corresponding to the two specific positions including the positions other than the head and neck.

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 and neck is set within the range of 1 to 1000 mA.

8. The electrical stimulation device according to claim 1, wherein (1) the electrical signal applied to the specific position is set to repeatedly perform a cycle including a first state in which a pulse wave including alternately generating a positive application and a negative application and a second state in which the pulse wave is in a rest state; or (2) the electrical signal applied to the specific position is set to sequentially include a first state in which a pulse wave always generating a positive application or a negative application, a second state in which the pulse wave is in a rest state, a third state in which a pulse wave generating an application opposite to the first state, and a fourth state in which the pulse wave is in a rest state.

9. The electrical stimulation device according to claim 8, wherein with respect to the electrical signal applied from one of the two sets of electrode pairs and the electrical signal applied from the other set of electrode pairs, in the electrical signal of (1), the time of either or both of the first state and the second state is set to be different between the two electrodes; or Regarding the electrical signals applied from one of the two pairs of electrodes and the electrical signals applied from the other pair of electrodes, in the electrical signals of (2), 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 electrodes.

10. The electrical stimulation device according to claim 8, wherein Regarding the electrical signals applied from one of the two pairs of electrodes and the electrical signals applied from the other pair of electrodes, in the electrical signals of (2), the application of the pulse wave in the first state is set to be opposite between the two electrodes, and the application of the pulse wave in the fourth state is set to be opposite between the two electrodes.

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

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

Images