Abstract:
Apparatus for measuring threshold sensitivity to a stimulus is disclosed. The apparatus includes sensory stimulation application apparatus for providing stimulus to a subject, computer apparatus for governing operation of the sensory stimulation application apparatus and operator interface apparatus for interfacing between an operator and the computer apparatus. The computer apparatus and the operator interface apparatus include apparatus for enabling an operator to selectably apply sensory stimulation to a patient minimally in accordance with any of the following protocols; method of limits, forced choice method; and staircase method. Other protocols which can be selected are Thermal Sensitivity Limen method and method of suprathreshold.

Description:
FIELD OF THE INVENTION 
     The present invention relates to medical equipment generally and more particularly to apparatus for sensory and/or pain threshold measurement. 
     BACKGROUND OF THE INVENTION 
     There exist a number of known techniques for sensory threshold measurement in general and thermal threshold measurement in particular. These are described, inter alia in the following publications: 
     Goran A. Jamal et al &#34;An Improved Automated Method for the Measurement of Thermal Thresholds. 1. Normal Subjects&#34;, Journal of Neurology, Neurosurgery and Psychiatry 1985; 48:354-360; 
     Clare J. Fowler et al &#34;A Portable System for Measuring Cutaneous Thresholds for Warming and Cooling&#34;, Journal of Neurology, Neurosurgery and Psychiatry 1987; 50:1211-1215; 
     Dan Ziegler et al &#34;Assessment of Small and Large Fiber Function in Long-term Type 1 (insulin-dependent) Diabetic Patients With and Without Painful Neuropathy&#34; Pain, 34(1988) 1-10; 
     Claus D. Hilz et al &#34;Thermal Discrimination Thresholds: A Comparison of Different Methods&#34;, Acta Neurol Scand 1990:81:533-540; 
     David Yarnitsky et al &#34;Studies of Heat Pain Sensation in Man: Perception Thresholds, Rate of Stimulus Rise and Reaction Time&#34;, Pain, 40(1990) 85-91. 
     SUMMARY OF THE INVENTION 
     The present invention seeks to provide improved apparatus for measuring sensory or pain thresholds. 
     There is thus provided in accordance with a preferred embodiment of the present invention apparatus for measuring threshold sensitivity to a stimulus including sensory stimulation application apparatus for providing the stimulus to a subject, computer apparatus for governing operation of the sensory stimulation application apparatus and operator interface apparatus for interfacing between an operator and the computer apparatus. The computer apparatus and the operator interface apparatus including apparatus for enabling an operator to selectably apply the stimulus to a patient in accordance with any of the following protocols: method of limits; forced choice method; and staircase method. The threshold sensitivities are warm sensation, cold sensation, hot pain and cold pain. 
     Additionally, in accordance with an embodiment of the present invention, the computer apparatus and the operator interface apparatus includes apparatus for enabling an operator to selectably apply the stimulus to a patient also in accordance with either of the following protocols: Thermal Sensitivity Limen method and method of suprathreshold. 
     Further, in accordance with an embodiment of the present invention, the stimulus is temperature applied to a desired location on the subject&#39;s body and wherein the sensory stimulation application apparatus includes apparatus for changing the temperature. 
     Still further, in accordance with an embodiment of the present invention, the apparatus for changing the temperature can change the temperature at rates generally between 0.1° C./sec and 4° C./sec. 
     Moreover, in accordance with an embodiment of the present invention, the apparatus of the present invention also includes apparatus for performing age-normalized matching of results of a test. 
     Additionally, in accordance with an embodiment of the present invention, the apparatus of the present invention also includes apparatus for defining a new test protocol. 
     Furthermore, in accordance with an embodiment of the present invention, the apparatus for defining a new test application protocol include apparatus for defining desired parameters from among the following group of parameters: adaptation temperature, sensation or pain to be measured, rate of temperature change, number of trials per test, length of time between trials, manual or automatic triggering of the start of a next trial or test, providing sound at the start of a test, randomization of the order of trials and inclusion of catch trials. 
     Finally, in accordance with an embodiment of the present invention, the apparatus for defining a new test protocol includes apparatus for defining a default test or series of tests. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     The present invention will be understood and appreciated more fully from the following detailed description, taken in conjunction with the drawings in which: 
     FIG. 1 is a generalized block diagram illustration of apparatus for measuring sensory and pain thresholds in accordance with a preferred embodiment of the present invention; 
     FIG. 2 is a detailed electrical schematic illustration of the apparatus of FIG. 1; and 
     FIGS. 3A, 3B and 3C are top and two side view illustrations, respectively, of a probe forming part of the apparatus of FIG. 1. 
    
    
     DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS 
     Reference is now made to FIGS. 1-3, which illustrate apparatus for measuring sensory and pain thresholds in accordance with a preferred embodiment of the present invention. The apparatus comprises at least one probe unit 10, also called a thermode, including a Peltier cooling/heating element 12 such as the MI1023T-03AC manufactured by Marlow Industries, Inc. of the U.S.A., which receives electrical power via a power amplifier 14 and is cooled by a cooling unit 16. Associated with the Peltier cooling/heating element 12 are a cooling water temperature sensor 18, a probe temperature sensor 20 and, optionally, a skin temperature sensor 22, all of which communicate via an A/D converter circuit 24 and an input/output interface 26, with a computer 28 such as a conventional laptop computer. Optionally, communications devices can be subsituted for computer 28 for communication with a computer already owned by an operator. 
     The cooling unit 16 comprises a heat exchanger 30, and a heat sink 32, with associated fan 34 associated, as illustrated, with a Peltier cooling element 36. A circulation pump 38, which receives electrical power via a pump control circuit 40, which is in turn controlled by computer 28 via input/output interface 26, circulates cooling fluid through conduits 42 extending between the probe unit 10 and heat exchanger 30. 
     In addition to the circuitry described above, the laptop computer 28 also controls via the input/output interface 26, a printer selector 44, which passes output information from the computer 28 to either an internal printer 45 or to an external printer (not shown). 
     Laptop computer 28 also controls via the input/output interface 26, a patient input/output unit 46, which communicates with a patient interface unit 48, such as a unit with two switches on it. 
     Laptop computer 28 also controls via the input/output interface 26, a temperature watch dog circuit 50, which operates a pulse width modulation circuit 52 which provides power to the probe via amplifier 14. 
     It will be appreciated that the apparatus of the present invention is typically packaged in a generally small unit. 
     A power supply 54, provides the necessary electrical power inputs to the various elements of the apparatus. The circuitry of FIG. 1 is fully described in the schematic of FIG. 2. Verbal description of the circuitry is considered to be unnecessary and redundant. 
     The probe unit 10 is illustrated in detail in FIGS. 3A, 3B and 3C. The probe unit 10 typically comprises at least one Peltier element 60 to be located close to the skin of a patient, covered by a plate 62, typically manufactured of aluminum. Six Peltier elements 60 are shown in FIG. 3A. 
     Between the Peltier elements 60 and next to the plate 62 are typically located a the probe temperature sensor 20 and, optionally, the skin temperature sensor 22. Skin temperature sensor 22 is located beneath plate 62 which has a hole 64 in it through which sensor 22 sense the skin temperature. 
     Heat exchangers 66 are typically located above the Peltier elements 60 and are operative to provide a temperature differential across Peltier elements 60. In order to enable rapid cooling and heating of the Peltier elements 60, heat exchangers 66 are typically maintained at a generally constant temperature, such as 32° C., through the operation of cooling unit 16. The probe unit 10 is typically able to provide a rate of change of temperature in the range of 0.1° C./sec to 4° C./sec although other, greater rates of temperature change are also possible. The rates of change of temperature typically vary in steps of 0.1° C./sec. 
     The heat exchangers 66 and Peltier elements 60 are surrounded on three sides by insulation 68, such as rubber, for maintaining the temperature of the heat exchangers 66 and for providing a housing to probe unit 10. 
     A cap 70 is additionally provided for connection to attaching apparatus (not shown), such as a belt, for attaching the probe unit 10 to the body of the patient. 
     The apparatus of the present invention performs the following measurement protocols: method of limits, forced choice method, Thermal Sensitivity Limen (TSL) method, method of staircase, and method of suprathreshold, for measuring thresholds of sensation of warm and cold and thresholds of pain due to heat and due to cold. 
     It will be noted that, for all measurements, the stimulus intensity is heat or cold. In heat and cold tests, the subject is asked to indicate when he first feels or ceases to feel heat. For pain measurements, he is asked to indicate when he first feels or ceases to feel pain. 
     In the method of limits protocol, described by Yarnitsky et al which article is incorporated herein by reference, for each trial, a stimulus intensity (either hot or cold) is steadily increased, at a selectable rate, from a reference adaptation temperature, typically 32° C., until a patient indicates, through patient interface unit 48, a point of change in the temperature of the probe unit 10. The stimulus intensity is typically then decreased to the adaptation temperature until a new trial is begun. Typically, a number of trials are performed and the threshold to the stimulus is typically defined as the average intensity of the trials. 
     It will further be appreciated that the method of limits requires that probe unit 10 be able to relatively quickly change stimulus intensities. 
     In the forced choice method, described by Jamal et al which article is incorporated herein by reference, the apparatus of the present invention presents a trial comprising two time periods, during one of which a stimulus is present and during the second no stimulus is present. At the end of the trial, the patient is asked to choose during which of the two time periods he felt a stimulus. If he is correct, the computer 28 scores the trial as a Success (S), otherwise, a score of Failure (F) is stored. The stimulus of the next trial will be either the same, or of longer or shorter duration in accordance with the Up-Down-Transform Rule (UDTR). 
     Alternatively, the trial is comprised of stimulating one of two probe units 10 and the patient has to indicate which probe unit 10 was activated. 
     The TSL method is described in the article by Navarro et al. &#34;Evaluation of Thermal and Pain Sensitivity in Type I Diabetic Patients&#34;, Journal of Neurology, Neurosurgery, and Psychiatry 1991, Vol 54, pgs. 60-64, which article is incorporated herein by reference. In the TSL method, the probe is set to the adaptation temperature and the temperature increased at a steady rate until the patient indicates, through patient interface unit 48, that heat sensation or heat pain was felt. The temperature is then decreased until cold or cold pain is felt. The difference between the reversal points (e.g. points where the patient indicated a change in sensation or pain), over a number of trials, is called the TSL. 
     The staircase method is described in the article by Fowler et al which article is incorporated herein by reference. The probe unit 10 is brought to a predefined temperature level and the patient indicates, via patient interface unit 48, whether or not the stimulus was perceived. The temperature of the probe unit 10 is then brought to a second temperature level which is higher than the first temperature level if the patient indicated that no stimulus was perceived and lower than the first temperature level otherwise. The response of the patient is recorded after each trial. In this manner, an approximate threshold level is determined and is used to determine the range of temperatures to be provided during the second stage of the test. 
     In the second stage of the test, the temperature of the probe unit 10 is originally brought to a temperature above the level of the approximate threshold level. The patient is then provided with a series of dynamic thermal ramps to bring the temperature to a predetermined level. If the patient indicates that a stimulus was perceived, the next predetermined temperature level is reduced by one predetermined step level. If the patient indicates that no stimulus was perceived, the predetermined temperature level is increased, typically by a predefined step amount. The test terminates when a predetermined number of negative responses have been received. The patient threshold level is defined as the temperature level midway between the mean temperature of the positive responses and the mean temperature of the negative responses. 
     The suprathreshold method is described in the article by Price D.D., &#34;Measurement of Pain: Sensory Discriminative Features&#34;, Psychological and Neural Mechanisms of Pain, Raven Press. NY, 1988, pp. 18-49. In the suprathreshold method, the extent of pain is measured. The temperature of the probe unit 10 is brought from the adaptation temperature to a level above the known threshold for pain (either hot or cold) for a predetermined length of time and then returned to the adaptation temperature. The patient is then asked to describe the intensity of the pain felt, where the intensity can be described by words, by a digital scale, typically varying between 0 and 10 where 0 represents no pain and 10 represents the maximal possible pain, or by a visual analog scale displayed on the screen of laptop computer 28. 
     In accordance with the present invention, the tests can be performed manually in which the operator have to indicate to laptop computer 28 to start a new trial, or automatically, in which the computer 28 begins a new trial after passage of a length of time set by the operator. 
     In accordance with the present invention, the results of a test can be compared to those for a normal population in accordance with the age of the patient. Results of tests with normal subjects, &#34;normal data&#34;, can be stored in computer 28 in age blocks. If desired, the normal data can be that provided by the manufacturer or it may be data gathered by the operator during his own experiments. 
     The computer 28 is typically also operative to provide post-processing on the test data. This post-processing typically comprises mathematical analysis of the test data as is required by the testing method, graphical operations for graphically providing to the operator the results of the tests, comparing the results of the test to an age-normalized group or to previous results received for the patient in previous tests. 
     The apparatus of the present invention enables an operator to choose the appropriate threshold for sensation or pain to be measured, the appropriate location on the body of the patient to place the probe, and the appropriate protocol by which to measure it. Laptop computer 28 stores information regarding each patient as well as the results of each test performed. Furthermore, laptop computer 28 can present the results graphically and can compare them to age-matched normal values for the selected location on the body. 
     In accordance with the present invention, an operator can modify or define a desired test sequence by programming laptop computer 28 to provide any desired sequence of stimulus intensities and time intervals. The programmable parameters are typically adaptation temperature, sensation or pain to be measured, rate of temperature change, number of trials per test, length of time between trials, manual or automatic triggering of the start of a next trial or test, and providing sound at the start of a test. The order of trials can be randomized and the operator can choose to have trials during which no stimulation occurs. Such trials are known as &#34;catch trials&#34;. 
     Furthermore, the computer 28 enables the operator to define a &#34;default&#34; test or series of tests which is the test or tests which will be run when a novice or non-operator is operating the apparatus of the present invention. 
     Annex A is source code of software running on laptop computer 28 for operating the apparatus of the present invention in the manner described hereinabove. 
     Annex B is a collection of typical screen displays preferably provided by the software of Annex A. 
     Annex C is a collection of typical instruction sets shown to the operator in connection with the screen displays of Annex B relating to programming a new type of test sequence. 
     It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention is defined only by the claims that follow: ##SPC1##