JPH09294815A - Transcranial electric stimulating device - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a transcranial electric stimulating device in which independently controlled electric currents are output from two electrode pairs. SOLUTION: A transcranial electric stimulating device 10 comprises two current generators 16, 18 for presenting an electric current, two electrode pairs 12, 14 removably fitted to the head skin of a patient, and a control unit 20 for independently controlling the respective current generators 16, 18. The respective electrode pairs 12, 14 are operated by the current generators 16, 18 special for the electrode pairs to output an independently controlled current.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a bioelectrical device used for cranial electrical stimulation therapy, and more particularly to a transcranial electrical stimulation device (TCES) for inducing analgesia and similar symptoms. is there.

[0002]

BACKGROUND OF THE INVENTION It has been demonstrated that non-invasive bioelectrical stimulation of specific areas of the brain produces pain-relieving effects. In particular, "The anterior pretnucleus"
ectalnucleus ", by H., Rees and MHT Roberts, P
Ain Volume 53, No. 2, May 2, 1993) explains that analgesia can be most effectively developed by stimulating the homeostatic endorphin action function of brain tissue. It has been demonstrated that there is. To date, transcranial electrical stimulation has been used to treat acute and chronic pain such as low back pain, headache, trigeminal neuralgia, postherpetic neuralgia, and other signs of neurosis.

"Low-frequency current density imaging of rabbits"("Low F
requency Current Density Imaging in Rabbits "by M.
LG Joy, 1993 Annual Fall Meeting of the Biomedi
calEngineering Society, Memphis State University,
A similar theme is stated in an article titled Memphis, Tennessee, October 21-24, 1993). In addition, "The administration of transcranial electrotherapy for the treatment of emotional confusion in alcoholics"("The administration of trans
cranial electric treatment for affective disturban
ces therapy in alcoholic patients "by EM Krupit
sky, Drug and Alcohol Dependence, 27 (1991) 1-6, El
The same is true for articles titled sevier Scientific Publishers Ireland Ltd.).

Since the therapeutic treatment by bioelectric stimulation devices is determined by the current required to obtain the individual therapeutic effect, this device is often more effective when using current sources than voltage sources. Are known. The device using a current source is designed so that the operator's hand is not affected by changes in impedance caused by movement of electrodes applied on the patient's scalp and drying of gel used as a conductive medium between the electrodes and the patient's scalp. It can be adapted without bothering.

The shortest and therefore most effective transcranial tract across the midbrain is the "Device for Pulse Current Action on".
Central Nervous System ") and is present between the patient's posterior skull and forehead, as described in U.S. Pat. No. 4,140,133 to Kastrubin. However, such transcranial tract The placement of the electrodes that connect the two requires that the patient's posterior skull be shaved, since most patients do not like to have their head shaved, two electrode pairs are commonly used, usually. One pair of electrodes is at both ends of the transcranial tract connecting the patient's left mastoid area and the forehead, and the other pair of electrodes is the patient's right mastoid area and the forehead. It is placed at both ends of the transcranial tract connecting to, where the first pair of electrodes stimulates the left side of the midbrain and the second pair of electrodes stimulates the right side of the midbrain.

Therefore, as shown in FIG. 1, the conventional TCE
The S device includes a signal generator based on a current source, which sends a rectangular pulse electrical signal to two electrode pairs removably attached to the patient's scalp as described above. In addition, TCES
The device includes a control unit with a user interface for adjusting the average current amplitude of the pulse.
Note that this pulse is given at a frequency of approximately 77 Hertz.

[0007]

A major drawback of the conventional TCES device is the signal generator connected in parallel to the two electrode pairs. This is because of the different impedances on the left and right sides of the patient's midbrain area, which are caused by physiological and structural differences and differences in the quality of the conductive medium.
This means that the doctor has no control over the individual electrode currents. As is apparent from FIG. 1, in this example, the current passing through the right electrode pair is larger than the current passing through the left electrode pair.

This parallel connection also means that there is no control over the splitting of the pulse passing through the left and right transcranial tracts. Therefore, the signal generator provides a rectangular pulse, but as shown in FIGS. 2 and 3, the uncertain shape is seen in the split portion of the pulse emitted from the right and left electrode pairs. .

In general, the design of conventional TCES devices often causes the physician to set the current amplitude value above the value needed to obtain the desired therapeutic effect. As a result, contrary to what the TCES device should look like, many patients complain that they feel burning during the treatment procedure.

The present invention has been made in view of the above problems, and an object thereof is to provide a transcranial electrical stimulator (TCES) that overcomes the above-mentioned drawbacks of conventional TCES devices.

[0011]

According to the present invention, (a)
At least two current generators providing current,
(B) at least two electrode pairs removably attached to the patient's scalp, and (c) each of the two electrode pairs,
A transcranial electrical stimulator is provided which comprises a control means for independently controlling each of the two current generators to obtain independently regulated currents. Note that the current includes pulses,
Each electrode pair is operated by a current generator dedicated to that electrode pair.

Furthermore, the invention is characterized in that the control means adjust the current amplitude of the pulse. The invention is also characterized in that the control means adjust the pulse width. The invention is further characterized in that the control means adjusts the frequency of the pulse. The invention is also characterized in that the pulses are substantially rectangular. The invention is further characterized in that the pulse is superimposed on a smooth current.

The invention further provides that the current is a net zero charge current and the product of the negative smoothed current amplitude and the width between successive pulses is the product of the positive pulse current amplitude and the pulse width. Characterized by equality. The invention is also characterized in that the current is a time-varying electrical stimulation current, which easily passes through the mesencephalic tissue in which the homeostatic endorphin action of the patient functions. The invention is further characterized in that each of the at least two current generators comprises a bilateral current source.

The invention further provides that the device comprises: (d) a battery for operating at least two current generators as described above,
(E) It is characterized by comprising a connector connected to an external power source for charging the storage battery, or a port for receiving a connector for connecting two electrode pairs to two current generators. The invention is further characterized in that the port comprises at least three pins, two of which are used for connecting the storage battery to an external power supply. The invention is further characterized in that the port comprises at least three pins, two of which are used to connect two current generators to two electrode pairs.

According to the present invention, (a) a storage battery,
(B) a processing means driven by the storage battery, and (c) a connector connected to an external power supply for charging the storage battery,
Alternatively, a device is provided that comprises a port that receives a connector that connects the processing means to the output device. The invention is further characterized in that the port comprises at least three pins, two of which are used for connecting the storage battery to an external power supply. The present invention also provides
The port is characterized in that it comprises at least three pins, two of which are used for connecting the processing means to the output device.

[0016]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The principle and operation of the transcranial electrical stimulation apparatus according to the present invention will be described below with reference to the drawings. FIG.
Is a Transcranial Electrical Stimulator (TCES) numbered 10
Is shown. It is constructed and operated in accordance with the present invention to provide transcranial electrical stimulation therapy to a patient.

The TCES device 10 is provided with a plurality of electrode pairs 12 and 14 which are detachably attached to the scalp of a patient. Although two electrode pairs 12, 14 are used in this embodiment, three or more electrode pairs may be provided depending on the treatment to be performed on the patient. The electrode pair 12 is composed of an electrode 12A that is detachably attached to the patient's scalp and the left papillary region, and an electrode 12B that is detachably attached to the left side of the patient's forehead. Similarly, the electrode pair 14 is composed of an electrode 14A that is detachably attached to the patient's scalp and the right nipple-like region, and an electrode 14B that is detachably attached to the patient's right side of the forehead. Typically, electrodes 12B and 14B are combined as a single electrode.

Further, the TCES device 10 is provided with the same number of current generators as the electrode pairs, and each electrode pair 12, 14 is provided with a current generator dedicated to the electrode pair. This is a feature of the present invention, in which the current generator 16 causes the electrode pair 12 to
And the current generator 18 activates the electrode pair 14. These current generators 16, 18 are powered by a DC / DC voltage converter 19 under the control of a microprocessor-based control unit 20. For this reason, the control unit 20 can cut off the voltage sent from the DC / DC voltage converter 19 in case of electrical danger to the patient.

As shown in FIGS. 6 to 8, the current Ito output from the current generators 16 and 18 for inducing analgesia.
t is two currents, a smooth current labeled Ism, and Ip
It is the sum of uls and a nearly rectangular pulse current (It
ot = Ism + Ipuls). The smooth current Ism consists of a zero potential current (see FIG. 6), a positive current (FIG. 7), or a negative current (FIG. 8), and the pulse current Ipuls consists of a positive current. This is because a positive current flows from the electrodes 12B and 14B to the electrodes 12A and 14A, and a negative current flows to the electrodes 12A and 14A.
It follows the convention of flowing from A to the electrodes 12B, 14B. By passing a negative current, it is possible to generate a net amount of zero-charge current during the tissue.

The control unit 20 is provided with a user interface 22 which allows adjustment of parameters such as the current value of the smooth current, the current amplitude of the pulse for the smooth current, the duration of the pulse and the frequency of the pulse. . Therefore, each current generator 16, 18 of the TCES device 10 of the present invention is capable of providing an independently controllable current to the patient. Normally, the average current amplitude Iev is 25
Within the range of μA to 4 mA, the pulse width is within the range of 3 ms to 4 ms, and the pulse frequency is 75
It is in the range of Hertz to 85 Hertz.

Therefore, the user interface 2
2 is a four controller for adjusting the current output from the electrode pair 12, first is a smoothing current amplitude controller 24 for adjusting the amplitude of the smooth current, and second is a pulse current for adjusting the current amplitude of the pulse. An amplitude controller 26, a pulse width controller 28 for adjusting the pulse width, and a pulse frequency controller 30 for adjusting the pulse frequency are provided. In addition, the user interface 22 is also provided with a smoothing current amplitude controller 32, a pulse current amplitude controller 34, a pulse width controller 36 and a pulse frequency controller 38 for adjusting the current flowing out of the electrode pair 14. There is.

The user interface 22 has a T
A selector switch 40 is preferably provided which sets the operating mode of the CES device 10. This selector switch 40 normally enables three basic operating modes. The first operating mode requires the setting of the controllers 24 to 30 controlling the current generator 16 and the controllers 32 to 38 controlling the current generator 18, and the second operating mode is
As will now be described with reference to FIG. 8, it is for providing a net zero charge current. The third mode of operation is to provide a time-varying electrical stimulation current, which, as described below with reference to Figures 9-11, has a homeostatic endorphin effect in the patient. It has the property of easily passing through brain tissue.

Conventionally, a net zero charge current has been obtained by reversing the polarity of successive pulses. However, compared to this conventional one, the current of the net zero charge according to the present invention is such that the product of the negative smoothing current amplitude and the width between consecutive pulses is the product of the positive pulse current amplitude and the pulse width. It is obtained by guaranteeing equality. This mode of operation is such that each current generator 16, 18 is a current source acting on both sides, and the negative current value of the smoothing current is determined based on the amplitude, pulse frequency and pulse width of the positive pulse current. To be achieved.

As is apparent from FIGS. 9-11, a further feature of the TCES device 10 is that the current generators 16, 18
This is to obtain an electric stimulation current that can change with time. This current has the property of passing through the mesencephalic tissue of the patient, which has homeostatic endorphin action, so compared with the general time constant current passing through the midbrain along a relatively narrow transcranial tract,
Easy to stimulate the midbrain. In particular, as shown in FIG. 11, the current generators 16 and 18 usually output currents having equal amplitudes, which are modulated in different phases or quadrature phases, and the combined currents thereof are passed currents IΣ. To work.

The TCES device 10 is further equipped with an actual current value I given to the patient via each electrode pair 12,14.
Current monitors 42 and 44 for measuring tot are provided. The current monitor 42 enables real-time measurement of the current output from the current generator 16 and controls the control unit 20.
Provide feedback to. This causes the control unit 20 to activate the alarm if necessary. Similarly, current monitor 44 enables real-time measurement of the current output from current generator 18 and provides feedback to control unit 20. Thereby, the control unit 20
Activates the alarm if needed. TCES device 1
Further, in 0, a memory 46 having endurance for storing a predetermined treatment and data record, a timer 48 for setting the duration of the treatment, and many bios for facilitating the determination of the treatment efficiency. A feedback sensor is preferably provided. Typical biofeedback sensors include respiratory rate sensors, blood pressure sensors, heart rate sensors, epidermal resistance sensors, body temperature sensors and the like.

The TCES device 10 is also characterized by a novel electric circuit design that prevents the risk of electric shock to the patient during treatment. In this electric circuit, a storage battery 5 that provides energy of electric pulses given to the patient
0 and a port 52 used to charge the storage battery 50 from an external power source or to operate the electrode pairs 12,14. The port 52 can receive a connector for connecting the storage battery 50 to an external power source or a connector for connecting the electrode pairs 12, 14 to the current generators 16, 18. In the present example, the port 52 has five pins, two of which are used to connect the storage battery 50 to an external power source, and three pins connect the electrode pairs 12, 14 to each current source. It is used to connect to the devices 16 and 18. Furthermore, the port 52 may be provided with more pins, eg for communication purposes.

The novel electrical circuit design described above has been implemented in various devices in which a user may be at risk of electric shock, such devices including Walkman devices, EEG. There are monitors, ECG monitors and the like. Every device has a processing means specific to the device and a port with at least three pins, two of these pins are used to connect the accumulator to an external power source and two output processing means. Used to connect to the device. If the port has three pins, one pin is used for both purposes.

Next, the operation of the TCES device 10 will be described.
First, the electrode pairs 12 and 14 are detachably attached to the scalp of the patient. The doctor then sets the operating mode. For example,
The selector switch 40 is operated to select the first operation mode. In this case, the smoothing current amplitude controller 24, the pulse current amplitude controller 26, the pulse width controller 28, and the pulse frequency controller 30 are set in order to adjust the current obtained from the electrode pair 12. Similarly, the smoothing current amplitude controller 32, the pulse current amplitude controller 34, the pulse width controller 36, and the pulse frequency controller 38 are set in order to adjust the current obtained from the electrode pair 14. Alternatively, instead of this setting, a predetermined treatment procedure may be selected from the endurance memory 46. Next, the timer 48 is set. During treatment, the doctor determines the efficiency of the treatment procedure by feedback from the sensor and finely adjusts the current output from the current generators 16,18.

Although described in a limited number of embodiments, it will be appreciated that the invention is capable of many variations, modifications and other applications.

[Brief description of drawings]

FIG. 1 shows a conventional TCES device with a single current generator that provides current to two electrode pairs connected in parallel.

FIG. 2 shows a rectangular pulse obtained by a current generator of a conventional TCES device.

FIG. 3 shows pulses emanating from the left electrode pair.

FIG. 4 shows pulses emanating from the right electrode pair.

FIG. 5 is a block diagram of a preferred embodiment of a TCES device according to the present invention.

FIG. 6 shows the electrical signal obtained by the TCES device of the present invention.

FIG. 7 shows the electrical signal obtained by the TCES device of the present invention.

FIG. 8 shows electrical signals obtained by the TCES device of the present invention.

FIG. 9 shows a mode of operation of the TCES device of the present invention in which a time-varying electrical stimulation signal is more likely to pass through homeostatic endorphin-active midbrain tissue of a patient.

FIG. 10 shows a mode of operation of the TCES device of the present invention in which a time-varying electrical stimulation signal is more likely to pass through a homeostatic endorphin-active midbrain tissue of a patient.

FIG. 11 shows a mode of operation of the TCES device of the present invention in which a time-varying electrical stimulation signal is more likely to pass through homeostatic endorphin-active midbrain tissue of a patient.

[Explanation of symbols]

 10 Transcranial electrical stimulator (TCES device) 12, 14 Electrode pair 16, 18 Current generator 19 DC / DC voltage converter 20 Control unit 22 User interface 24-38 Controller 40 Selector switch 44 Current monitor 46 Memory 48 Timer 50 storage battery 52 ports

 ─────────────────────────────────────────────────── ─── Continuation of the front page (71) Applicant 596058982 Serge Geyatigorski Israel, Jerusalem, Giro, 304/35 Margarito (72) Inventor Jechiel Hymovich Israel, Nes Ziona 70400, Hatayashim Street 15 (72) Inventor Felix Azriel Kochubievski Israel, Rehovot, Moshe Mizurachi 4/1 (72) Inventor Serge Pyatigorski Israel, Jerusalem, Giro, Margarito 304/35

Claims (12)

[Claims] 1. (a) at least two current generators for providing a current containing pulses; (b) at least two electrode pairs removably attached to the scalp of a patient; (c) said at least two; A transcranial electrical stimulator for electrically stimulating a specific part of the brain of a patient, comprising: a control means for regulating and controlling each of the two current generators, wherein each of the at least two electrode pairs is the current generator. Independently activated, each of the at least two electrode pairs outputting a current that is globally regulated to pass through a particular portion of a patient's brain. apparatus. 2. The apparatus of claim 1 wherein said control means adjusts the current amplitude of said pulse. 3. The apparatus of claim 1, wherein the control means adjusts the width of the pulse. 4. The apparatus of claim 1, wherein the control means adjusts the frequency of the pulse. 5. The apparatus of claim 1, wherein the pulse is superimposed on a smooth current. 6. The apparatus of claim 1, wherein the pulse is substantially rectangular. 7. The current is a net zero charge current,
2. The apparatus of claim 1, wherein the product of the negative smoothed current amplitude and the width between successive pulses is equal to the product of the positive pulsed current amplitude and the pulse width. 8. The device according to claim 1, wherein the electric current is a time-varying electrical stimulation current that easily passes through the midbrain tissue of the patient having homeostatic endorphin action. 9. The apparatus of claim 1, wherein each of the at least two current generators includes a bilateral current source. 10. (d) a storage battery for driving the at least two current generators, (e) a connector connected to an external power source for charging the storage batteries, or the at least two current generators to the at least two current generators. The device of claim 1 comprising a port connected to the storage battery for receiving any of the connectors connecting one electrode pair. 11. The apparatus of claim 10, wherein the port has at least three pins, two of the at least three pins being used to connect the accumulator to the external power source. . 12. The port has at least three pins, two of the at least three pins being used to connect the at least two current generators to the at least two electrode pairs. Claim 1
The apparatus of claim 0.