WO2010024491A1 - The clinical testing method for neuropathic pain, and a measuring device thereof - Google Patents

The clinical testing method for neuropathic pain, and a measuring device thereof Download PDF

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Publication number
WO2010024491A1
WO2010024491A1 PCT/KR2008/005561 KR2008005561W WO2010024491A1 WO 2010024491 A1 WO2010024491 A1 WO 2010024491A1 KR 2008005561 W KR2008005561 W KR 2008005561W WO 2010024491 A1 WO2010024491 A1 WO 2010024491A1
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pain
tactile sense
testee
applying
causing
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PCT/KR2008/005561
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French (fr)
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Doo-Hyun Lee
Hyun-Taek Kim
June-Seek Choi
Min-Hee Pang
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Vivozon, Inc.
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Publication of WO2010024491A1 publication Critical patent/WO2010024491A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4824—Touch or pain perception evaluation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4824—Touch or pain perception evaluation
    • A61B5/4827—Touch or pain perception evaluation assessing touch sensitivity, e.g. for evaluation of pain threshold
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4824—Touch or pain perception evaluation
    • A61B5/4827—Touch or pain perception evaluation assessing touch sensitivity, e.g. for evaluation of pain threshold
    • A61B5/483—Touch or pain perception evaluation assessing touch sensitivity, e.g. for evaluation of pain threshold by thermal stimulation
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/0001—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00 by organoleptic means
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/15—Medicinal preparations ; Physical properties thereof, e.g. dissolubility
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/44—Detecting, measuring or recording for evaluating the integumentary system, e.g. skin, hair or nails
    • A61B5/441—Skin evaluation, e.g. for skin disorder diagnosis
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/28—Neurological disorders

Definitions

  • the pain causing step (SlO) is carried out for a set time period to apply the pain and tactile sense to the testees.
  • the pain and the tactile sense are repeatedly applied several times and there are breaks between the repeated pain and tactile sense applying time periods, whereby the pain similar to the neuropathic pain can be caused.
  • the time period to apply the pain and tactile sense to cause the pain to the testees can be decided in such a way that the time period is increased by one second according to the level of the pain of each testee.
  • a time period to apply painful electrical stimulus and heat stimulus is set within a range of 0.1 second to 10 seconds.
  • the number of repetitions to apply the pain and the tactile sense can be increased according to the testees' conditions.
  • the pain testing step (S20) can be carried out in such a way as to check the level of the testee' s pain by applying the tactile sense after a lapse of the set time period. That is, it is preferable to check whether or not the testee feels the pain when only the tactile sense is applied to the testee.
  • the experimenter can cause the neuropathic pain to the testee by selecting one of a procedure including the steps of first applying the tactile sense to the testee and applying the pain when the tactile sense is ended, a procedure including the steps of first applying the tactile sense and applying the pain before the tactile sense is ended, a procedure including the steps of first applying the tactile sense and applying the pain after a lapse of a predetermined time period from the end of the tactile sense, a procedure including the steps of first applying the pain and applying the tactile sense when the pain is ended, a procedure including the steps of first applying the pain and applying the tactile sense before the pain is ended, and a procedure including the steps of first applying the pain and applying the tactile sense after a lapse of a predetermined time period from the end of the pain.
  • the experimenter can previously set the selective matters according to the experimental conditions using the setting part 52. Accordingly, the experimenter can conveniently test the testee in the previously set experimental values not by selecting the experimental conditions one by one but by selecting the previously set conditions.
  • the experimental values set in the setting part 52 can be saved in a memory 56, and the saved experimental values can be used by the setting part 52.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Pain & Pain Management (AREA)
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Abstract

Disclosed therein are a method and a system for testing a neuropathic pain of a human testee. The method for testing the neuropathic pain includes the steps of : applying a pain and a tactile sense to the skin of a testee to cause a neuropathic pain to the testee and causing a pain relative to the tactile sense; and testing the level of the testee' s pain after the pain causing step.

Description

[DESCRIPTION] [invention Title]
THE CLINICAL TESTING METHOD FOR NEUROPATHIC PAIN, AND A MEASURING DEVICE THEREOF [Technical Field]
The present invention relates to a method and a system for testing a neuropathic pain of a human testee.
[Background Art] In general, a neuropathic pain is one of chronic pain diseases and caused by a damage of a nervous system, which takes charge of pains, even though there is actually no damage on a pain area. Since the nervous system causes a pain while acting abnormally and excessively, neuropathic pain patients feel a severe pain even by a light contact stimulus. Now, in order to cure the neuropathic pain, people in the academic circles and worldwide pharmaceutical companies are studying records and history of the neuropathic pain and developing medical remedies. In order to develop the medical remedies for the neuropathic pain, the remedial result and safety verified in animal tests must be verified again through human tests. For verification, now, the pain remedies can be sold only when they pass a three-step clinical test for normal persons or patients.
In the first step of the clinical test, only safety and actions in the body of a new drug candidate are verified in a small number of normal testees under the control of a clinician.
After safety of the new drug candidate is verified, the clinician prescribes and tests the new drug for a small number of actual patients in the second step of the clinical tests, and then, prescribes and tests the new drug for a large number of actual patients in the third step. Most of the new drugs go to the second step without a particular difficulty in the first step. The reason is that safety of the new drugs was previously verified through the animal test through a strict method, for instance, GLP (Good Laboratory Practice) . However, in fact, many new drug candidates are left out of the second step of the clinical test. The falling- out may occur in the following cases: first, in a case where ineffective new drug candidate is selected due to an error in the animal test step; second, in a case where there is a difference in disease records and histories between human beings and animals; and third, in a case where there is an error in selection of patients in the second step of the clinical test. If the safety and remedial result of the new drug candidate can be verified in the first step of the clinical test not for patients but for normal persons, a verification of the remedial result of the new drug, which will be carried out in the second step of the clinical test, can be achieved also in the first step of the clinical test. Furthermore, when non-effect of the new drug candidate is previously verified in the first step of the clinical test, since unnecessary second step can be stopped, a great deal of time and costs required for development of the new drug can be reduced. However, reality is not as the above since remedial result verification methods of new drug candidates in the first step of the clinical test is strictly limited.
Accordingly, in order to raise a success rate in the second step of the clinical test and reduce wasteful expenditures and time generated in the unnecessary second step, new drug discovery and development companies need a method to verify the remedial result for normal persons.
However, the clinician must cause the neuropathic pain to the normal persons and prescribe the new drug in order to verify the remedial result of a neuropathic pain remedy.
However, it is very difficult to cause symptoms similar to the neuropathic pain to the normal persons.
Till now, there were various efforts to cause the neuropathic pain to the normal persons, and as an example of the efforts, there is a capsaicin model. The capsaicin model is a method to cause a pain temporarily continuing for two to six hours by injecting a very small amount of capsaicin into the skin of the normal person or by attaching a capsaicin patch to the skin. After capsaicin is injected, a burning pain is caused for several minutes. After a predetermined time period from the pain of the short time period, the pain is caused again around the area of the body where capsaicin was injected. Since the secondary pain is accepted as a severe pain even by a light stimulus, it is used as an experimental model to reproduce allodynia (or called secondary hyperalgesia: symptom causing a severe pain even by a light touch) , which is symptoms of the neuropathic pain. However, the capsaicin model has a problem in safety and consistency of experimental results and did not obtain reliable experimental results till now. The reason is that test stimuli for measuring the level of the pain caused by capsaicin are subjective and there are many variables (since an experimenter directly stimulates a testee's skin with a thin fiber or swab called von Frey filament) , and that there is a reciprocal action between the experimenter and the testee (for instance, the testee may feel pains of different levels according to experimenters, who performs the test, or the experimenter' s attitude or experiment progress may be varied according to testees) .
[Disclosure] [Technical Problem]
Accordingly, the present invention has been made in an effort to solve the above-mentioned problems occurring in the prior arts, and it is an object of the present invention to provide a method and a system for testing a neuropathic pain of a human testee, which can overcome the limit of the capsaicin model and correctly and accurately carry out a clinical test of a neuropathic pain.
Another object of the present invention is to provide a method and a system for testing a neuropathic pain of a human testee, which can correctly cause allodynia continued in a normal person for a short time period by applying a pain and a tactile sense to the normal person.
A further object of the present invention is to provide a method and a system for testing a neuropathic pain of a human testee, which can provide a test result of enhanced objectivity and exactitude by giving a uniform tactile test stimulus to measure the level of allodynia.
[Technical Solution]
To achieve the above objects, in an aspect of the present invention, the present invention provides a method for testing a neuropathic pain of a human testee including the steps of: causing a neuropathic pain to a testee by applying a pain and a tactile sense to the testee' s skin; and testing the level of the testee' s pain after the pain causing step.
In this instance, the pain causing step is carried out for a set time period to apply the pain and tactile sense in such a way that the pain and the tactile sense are repeatedly applied several times and there are breaks between the repeated pain and tactile sense applying time periods .
Furthermore, the pain and tactile sense causing step selects one of: a procedure including the steps of first applying the tactile sense to the testee and applying the pain when the tactile sense is ended; a procedure including the steps of first applying the tactile sense and applying the pain before the tactile sense is ended; a procedure including the steps of first applying the tactile sense and applying the pain after a lapse of a predetermined time period from the end of the tactile sense; a procedure including the steps of first applying the pain and applying the tactile sense when the pain is ended; a procedure including the steps of first applying the pain and applying the tactile sense before the pain is ended; and a procedure including the steps of first applying the pain and applying the tactile sense after a lapse of a predetermined time period from the end of the pain.
Moreover, the pain selects one of heat stimulus, needle stimulus, electric stimulus, and pain inducer, and the tactile sense selects one of brush stimulus, swab stimulus, and electric stimulus.
In addition, the pain testing step is to check the level of the pain by applying the tactile sense to the testee after a lapse of a predetermined time period. Additionally, the pain testing step further includes the steps of: prescribing a new drug candidate or placebo to the testee after the level of the testee' s pain is checked; and checking whether or not the testee feels the pain when the tactile sense is applied to the testee after a lapse of the set time period.
In another aspect of the present invention, the present invention provides a system for testing a neuropathic pain of a human testee including: a pain and tactile sense causing part for causing a pain and a tactile sense; a pain and tactile sense controlling part for controlling strengths of the pain and the tactile sense of the pain and tactile sense causing part; and a controller for controlling the pain and tactile sense controlling part and forming and managing data of control states of the pain and tactile sense controlling part.
Furthermore, the pain and tactile sense causing part includes: a hemispherical case; a heat generating member mounted inside the case for generating heat; a range setting member for setting a range of heat generated from the heat generating member; a contact member mounted on an outer face of the case for transferring an electric current; and a through hole formed on the contact member for passing heat generated from the heat generating member.
Moreover, the controller includes: a pain and tactile sense selecting part for selectively causing the pain and tactile sense of the pain and tactile sense causing part; a strength controlling part for controlling a strength of the pain and tactile sense causing part; a time controlling part for controlling a pain and tactile sense causing time period of the pain and tactile sense causing part; a cycle controlling part for controlling a pain and tactile sense causing cycle of the pain and tactile sense causing part; and a cycle number controlling part for controlling the number of cycles of the cycle controlling part. In this instance, the testing system may further includes a setting part for previously setting selective matters of the strength controlling part, the time controlling part, the cycle controlling part, and the cycle number controlling part.
[Description of Drawings]
FIG. 1 is a flow chart showing a method for testing a neuropathic pain of a human testee according to the present invention.
FIG. 2 is a schematic diagram showing a pain causing stimulus in the present invention.
FIG. 3 is a schematic diagram showing a system for testing a neuropathic pain of a human testee.
FIG. 4 is a view showing essential parts of the present invention.
FIG. 5 is a block diagram showing other essential parts of the present invention.
<Explanation of essential reference numerals in drawings>
10 : pain causing part 30: pain controlling part
50: controller
[Mode for Invention] Reference will be now made in detail to the preferred embodiment of the present invention with reference to the attached drawings.
As shown in FIG. 1, in a first preferred embodiment of the present invention, a method for testing a neuropathic pain of a human testee includes the steps of: (SlO) causing a pain to the testee by applying a pain and a tactile sense to the testee' s skin; and (S20) testing the level of the testee' s pain after the pain causing step (SlO) .
Here, an experimenter can select a great number of testees, cause a pain, which is very similar to the neuropathic pain, to the testees, and then test the level of the testees' pains using the tactile sense.
The pain causing step (SlO) is carried out for a set time period to apply the pain and tactile sense to the testees. In this instance, the pain and the tactile sense are repeatedly applied several times and there are breaks between the repeated pain and tactile sense applying time periods, whereby the pain similar to the neuropathic pain can be caused. Here, the time period to apply the pain and tactile sense to cause the pain to the testees can be decided in such a way that the time period is increased by one second according to the level of the pain of each testee. In this instance, it is preferable that a time period to apply painful electrical stimulus and heat stimulus is set within a range of 0.1 second to 10 seconds. Moreover, the number of repetitions to apply the pain and the tactile sense can be increased according to the testees' conditions.
In this instance, in case of normal adults, it is preferable that the application of the pain and the tactile sense is repeated five times to ten times. Furthermore, the breaks can be increased by the unit of second or the unit of minute according to the testees' conditions. In this instance, in case of the normal adults, the break time period of about 10 seconds to 3 minutes is preferable. As described above, when the stimulus is repeatedly applied to the skin of each testee, the testee' s tactile nerve and pain nerve act at the same time, and hence, the testee may feel the pain even though only the tactile sense is applied to the testee.
In addition, one of heat stimulus, needle stimulus, electric stimulus, and pain inducer can be applied and used in order to cause the pain to the testee, and one of brush stimulus, swab stimulus, and electric stimulus can be applied and used in order to apply the tactile sense to the testee. Here, the method to apply the pain and the tactile sense to the testee is not restricted to the above, and all of methods to cause temporary pain and tactile sense can be applied to the present invention. The minimum area to apply the pain is a circular area of a diameter ranging from 0.5cm to 1.5cm, and an area to apply the tactile sense is a circular area of a diameter ranging from lcm to 5cm outwardly from the pain area. In this instance, the pain area and the tactile sense area may be overlapped or not overlapped. Here, the heat stimulus can use a strength of temperature of a heater or brightness (Lux) of a lamp, the needle stimulus can use the pricking level of a needle which pricks the testee' s skin, and the electric stimulus can use a strength of an electric current. In this instance, the heat stimulus and the electric stimulus can control their strengths according to the testee' reactions. Furthermore, for the pain inducer, capsaicin, which is injected into the testee' skin to cause the pain, can be used. Moreover, the brush stimulus and the swab stimulus to apply the tactile sense to the testee can be applied to the testee when the experimenter directly applies the tactile sense to the testee using a brush or a swab or applies the tactile sense using a device to actuate the brush or the swab.
Accordingly, the experimenter can cause the pain after setting the strength of the pain and tactile sense according to the testee' conditions while increasing and applying the strength of the pain and tactile sense to the testee. That is, in case of the electric stimulus, the testee can feel the tactile sense in a specific strength when the experimenter gives a uniform strength ranging from 0.01mA to 1OmA to the testee while increasing the strength. In this instance, the experimenter can carry out the test using the strength of the electric stimulus, which the testee felt. Furthermore, in case of the heat stimulus, the experimenter can give a uniform strength ranging from lOLux to l,000Lux to the testee using light of the lamp while increasing the strength. In this instance, in general, normal adults can feel the pain when a uniform strength ranging from lOOLux to 300Lux is applied to the normal adults while being increased.
Additionally, while the electric stimulus to cause the tactile sense is varied according to the testees' conditions, the testees can feel the tactile sense when a uniform strength ranging from 0.03mA to ImA is applied to the testees while being increased. Such a strength of the electric current cannot give the pain to the testees, but the testees can feel a contact stimulus similar to the tactile sense.
Furthermore, the pain testing step (S20) can be carried out in such a way as to check the level of the testee' s pain by applying the tactile sense after a lapse of the set time period. That is, it is preferable to check whether or not the testee feels the pain when only the tactile sense is applied to the testee.
Moreover, the method for testing the neuropathic pain according to the present invention further includes the steps of: (S30) prescribing a new drug candidate or placebo to the testee after it is judged that the testee feels the pain; and (S40) checking whether or not the testee feels the pain when the tactile sense is applied to the testee after a lapse of the set time period. In this instance, when the new drug candidate or placebo is prescribed to the testee, the testee' s pain can be relieved.
That is, after the experimenter checks the level of the testee' s pain by applying the tactile sense to the testee, the experimenter prescribes the new drug candidate or placebo to the testee in an oral intake manner or using an intravenous injector and checks the level of the testee' s pain by applying the tactile sense to the testee again after a lapse of a predetermined time period. In this instance, the experimenter tests the pain by applying the tactile stimuli several times to obtain an average value of the levels of the pains.
Accordingly, since the testee complains of different pain levels of several times corresponding to the tactile stimuli of several times, the experimenter can obtain the average value using the different pain levels. That is, the experimenter can check the level of the pain by applying the tactile stimuli several times for the predetermined time period after relieving the pain by dosing a pain-killer to the testee, who complains of the pain. In this instance, the experimenter can test a pain-relieving effect of the pain-killer as time goes by.
Furthermore, as shown in FIG. 2, in the pain and tactile sense applying step (SIl), the experimenter can cause the neuropathic pain to the testee by selecting one of a procedure including the steps of first applying the tactile sense to the testee and applying the pain when the tactile sense is ended, a procedure including the steps of first applying the tactile sense and applying the pain before the tactile sense is ended, a procedure including the steps of first applying the tactile sense and applying the pain after a lapse of a predetermined time period from the end of the tactile sense, a procedure including the steps of first applying the pain and applying the tactile sense when the pain is ended, a procedure including the steps of first applying the pain and applying the tactile sense before the pain is ended, and a procedure including the steps of first applying the pain and applying the tactile sense after a lapse of a predetermined time period from the end of the pain.
Here, when the experimenter applies the tactile sense simultaneously with the end of the pain applied to the testee' s skin or applies the pain simultaneously with the end of the tactile sense, the testee' s tactile nerve and pain nerve act at the same time, and hence, the testee feels the pain also by the tactile sense. Accordingly, since the testee feels the tactile sense into a pain when the tactile sense is applied to the testee' s skin after a lapse of the predetermined time period, allodynia can be easily caused. As described above, the test carried out using the method of the present invention can be achieved in such a way as to control the strengths, time periods, cycles and so on of the stimuli according to the testee' conditions or the new drug candidate's conditions. Therefore, the electric stimulus and the heat stimulus can be applied to the testee' s skin in various manners, and hence, various experimental results can be obtained.
In the meantime, as shown in FIG. 3, in another preferred embodiment of the present invention, a system for testing a neuropathic pain of a human testee according to the present invention includes: a pain and tactile sense causing part 10 for causing a pain and a tactile sense; a pain and tactile sense controlling part 30 for controlling strengths of the pain and the tactile sense of the pain and tactile sense causing part 10; and a controller 50 for controlling the pain and tactile sense controlling part 30 and forming and managing data of control states of the pain and tactile sense controlling part 30.
Here, the pain and tactile sense causing part 10 can apply electricity and heat to the testee' s skin, and be used in a state where it is in contact with the testee' s skin.
In this instance, the pain and tactile sense causing part 10 can be fixed to the testee' s skin using a strap (not shown) .
Furthermore, the pain and tactile sense controlling part 30 includes an electric stimulator 31 and a heat controller 33 for respectively controlling strengths of electricity and heat generated from the pain and tactile sense causing part 10 to apply the pain and the tactile sense to the testee' s skin. In this instance, when the pain and tactile sense causing part 10 uses light to cause the pain to the testee, the heat controller 33 may be a light intensity controller. Moreover, when the pain and tactile sense causing part 10 uses heat to cause the pain to the testee, the heat controller 33 may be a temperature controller (not shown) , which can control strength of temperature. Additionally, preferably, the electric stimulator 31 used to cause the tactile sense to the testee can control the strength of the electric current in the unit of mA. Additionally, the controller 50 may be a personal computer, which can control the pain and tactile sense controlling part 30. That is, the personal computer can be used by being equipped with a program to control the pain and tactile sense controlling part 30 therein. In this instance, the pain and tactile sense controlling part 30 can be connected to the personal computer through an interface embedded in the controller 50. Here, the interface may be an USB.
Furthermore, as shown in FIG. 4, the pain and tactile sense causing part 10 includes: a hemispherical case 11; a heat generating member 13 mounted inside the case 11 for generating heat; a range setting member 15 for setting a range of heat generated from the heat generating member 13; a contact member 17 mounted on an outer face of the case 11 for transferring an electric current; and a through hole 19 formed on the contact member 17 for passing heat generated from the heat generating member 13.
First, when the heat generating member 13 is a lamp, a reflecting material (not shown) for reflecting light to the range setting member 15 is coated on the inner face of the case or a reflecting member (not shown) is aligned in the case 11. In this instance, it is preferable that the lamp is an infrared lamp or a tungsten lamp. Alternatively, the heat generating member 13 may be a heater. Moreover, the range setting member 15 may be a lens, which can collect light diffused and irradiated from the lamp of the heat generating member 13 to make an irradiation range of light narrow. In this instance, it is preferable that the lens is a convex lens. In this instance, it is important to properly control a distance between the lamp of the heat generating member 13 and the convex lens to collect irradiation angles of light. Additionally, the range setting member 15 may be a reflecting shade, whose lower portion gets narrow inwardly to reduce the irradiation range of light. In addition, also in case where the heat generating member 13 is the heater, a range of the generated heat can be set using the reflecting shade.
As described above, the system for testing the neuropathic pain according to the present invention can concentrate heat (light) on the testee's skin by restricting a diffusion range of heat (light) , whereby the test can be carried out accurately with a short time period.
Furthermore, since the contact member 17 is in direct contact with the testee' s skin, it can transfer the electric current to the testee's skin.
In the meantime, the through hole 19 can transfer heat of the heat generating member 13 to the testee's skin without any interference with the contact member 17. As described above, the heat generating member 13 of the present invention can stimulate the testee' s pain sense, and the contact member 17 can stimulate the testee' s tactile sense .
Moreover, it is preferable that the contact member 17 is in a grid form. In this instance, the grid-shaped contact member 17 can evenly transfer the electric current to the testee' s skin, and generally pass heat of the heat generating member 13 due to the grid (mesh) form.
In addition, as shown in FIG. 5, the controller 50 includes: a pain and tactile sense selecting part 51 for selectively causing the pain and tactile sense of the pain and tactile sense causing part 10; a strength controlling part 53 for controlling a strength of the pain and tactile sense causing part 10; a time controlling part 55 for controlling a pain and tactile sense causing time period of the pain and tactile sense causing part 10; a cycle controlling part 57 for controlling a pain and tactile sense causing cycle of the pain and tactile sense causing part 10; and a cycle number controlling part 59 for controlling the number of cycles of the cycle controlling part 57.
Here, using the pain and tactile sense selecting part 51, the experimenter can select whether to apply the electric stimulus or apply the heat stimulus or apply all of the electric stimulus and the heat stimulus to the testee to selectively apply the pain and tactile sense to the testee according to experimental conditions.
Furthermore, the experimenter can control strengths of the electric stimulus and the heat stimulus using the strength controlling part 53, control the time period of the electric stimulus and the heat stimulus using the time controlling part 55, apply the electric stimulus and the heat stimulus in a predetermined cycle or a unspecified cycle using the cycle controlling part 57, and control the number of cycles using the cycle number controlling part 59.
As described above, the experimenter can carry out the test in various experimental values according to the experimental conditions using the controller 50.
Moreover, the controller 50 may further include a setting part 52 for previously setting selective matters of the strength controlling part 53, the time controlling part
55, the cycle controlling part 57 and the cycle number controlling part 58.
Here, the experimenter can previously set the selective matters according to the experimental conditions using the setting part 52. Accordingly, the experimenter can conveniently test the testee in the previously set experimental values not by selecting the experimental conditions one by one but by selecting the previously set conditions. In this instance, the experimental values set in the setting part 52 can be saved in a memory 56, and the saved experimental values can be used by the setting part 52.
In this instance, the experimental values set by the setting part 52 are formed into data according to which one of the electric stimulus and the heat stimulus is first carried out or according to previously set values of time periods, strengths of stimuli, and the number of cycles, and then, the data can be saved in the memory 56. Additionally, the pain and tactile sense selecting part 51, the strength controlling part 53, the time controlling part 55, the cycle controlling part 57, the cycle number controlling part 59, and the setting part 52 can be controlled by a controlling part 54. As described above, the present invention can be utilized in development of new drugs using obtained data since it can test the testee' s pain using the tactile sense after causing the pain to the testee and obtain data of the pain.
The preferred embodiments of the present invention are described as the above. It will be appreciated by those skilled in the art that the technical construction of the present invention can be embodied in other detail forms without any change in its technical idea or essential features .
Accordingly, while the present invention has been described with reference to the particular illustrative embodiment, it is not to be restricted by the embodiment but only by the appended claims. It is to be appreciated that those skilled in the art can change or modify the embodiment without departing from the scope and spirit of the present invention.
[industrial Applicability] As described above, the method and system for testing the neuropathic pain according to the present invention can overcome the limit of the capsaicin model through the correct clinical test of the neuropathic pain, and enhance objectivity and exactitude by giving a test stimulus of a uniform and exact strength to exactly measure the level of allodynia .
Moreover, the present invention can maximize the level of allodynia since it causes allodynia using the method of applying the heat stimulus and the electric stimulus together.

Claims

[CLAIMS]
[Claim l]
A method for testing a neuropathic pain of a human testee comprising the steps of: (SlO) causing a neuropathic pain to a testee by applying a pain and a tactile sense to the testee' s skin; and
(S20) testing the level of the testee' s pain after the pain causing step (SlO) .
[Claim 2]
The testing method according to claim 1, wherein the pain causing step (SlO) is carried out for a set time period to apply the pain and tactile sense in such a way that the pain and the tactile sense are repeatedly applied several times and there are breaks between the repeated pain and tactile sense applying time periods.
[Claim 3] The testing method according to claim 1, wherein the pain and tactile sense causing step (SlO) selects one of: a procedure including the steps of first applying the tactile sense to the testee and applying the pain when the tactile sense is ended; a procedure including the steps of first applying the tactile sense and applying the pain before the tactile sense is ended; a procedure including the steps of first applying the tactile sense and applying the pain after a lapse of a predetermined time period from the end of the tactile sense; a procedure including the steps of first applying the pain and applying the tactile sense when the pain is ended; a procedure including the steps of first applying the pain and applying the tactile sense before the pain is ended; and a procedure including the steps of first applying the pain and applying the tactile sense after a lapse of a predetermined time period from the end of the pain. [Claim 4]
The testing method according to any one of claims 1 to
3, wherein the pain selects one of heat stimulus, needle stimulus, electric stimulus, and pain inducer, and the tactile sense selects one of brush stimulus, swab stimulus, and electric stimulus.
[Claim 5]
The testing method according to claim 1, wherein the pain testing step (S20) is to check the level of the pain by applying the tactile sense to the testee after a lapse of a predetermined time period.
[Claim β] The testing method according to claim 5, wherein the pain testing step (S20) further comprises the steps of:
(S30) prescribing a new drug candidate or placebo to the testee after the level of the testee' s pain is checked; and (S40) checking whether or not the testee feels the pain when the tactile sense is applied to the testee after a lapse of the set time period.
[Claim 7]
A system for testing a neuropathic pain of a human testee comprising: a pain and tactile sense causing part (10) for causing a pain and a tactile sense; a pain and tactile sense controlling part (30) for controlling strengths of the pain and the tactile sense of the pain and tactile sense causing part (10); and a controller (50) for controlling the pain and tactile sense controlling part (30) and forming and managing data of control states of the pain and tactile sense controlling part (30) .
[Claim 8]
The testing system according to claim I1 wherein the pain and tactile sense causing part (10) comprises: a hemispherical case (11);
a heat generating member (13) mounted inside the case (11) for generating heat;
a range setting member (15) for setting a range of heat generated from the heat generating member (13);
a contact member (17) mounted on an outer face of the case (11) for transferring an electric current; and
a through hole (19) formed on the contact member (17) for passing heat generated from the heat generating member (13) .
[Claim 9]
The testing system according to claim 8, wherein the contact member (17) is in a grid form.
[Claim 10]
The testing system according to claim 7, wherein the controller (50) comprises: a pain and tactile sense selecting part (51) for selectively causing the pain and tactile sense of the pain and tactile sense causing part (10) ;
a strength controlling part (53) for controlling a strength of the pain and tactile sense causing part (10);
a time controlling part (55) for controlling a pain and tactile sense causing time period of the pain and tactile sense causing part (10);
a cycle controlling part (57) for controlling a pain and tactile sense causing cycle of the pain and tactile sense causing part (10); and
a cycle number controlling part (59) for controlling the number of cycles of the cycle controlling part (57) .
[Claim 11] The testing system according to claim 10, further comprising: a setting part (52) for previously setting selective matters of the strength controlling part (53), the time controlling part (55), the cycle controlling part (57), and the cycle number controlling part (58) .
PCT/KR2008/005561 2008-08-27 2008-09-19 The clinical testing method for neuropathic pain, and a measuring device thereof WO2010024491A1 (en)

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