throbber

`a ODBia DaeOEE
`
`
`30 October 1997 (30.10.97)
`A61B 5/00, 5/103, 5/117 (43) International Publication Date:
`
`
`
`PCT
`
`WORLD INTELLECTUAL PROPERTY ORGANIZATION
`International Bureau
`
`INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)
`
`(51) International Patent Classification 6;
`
`(11) International Publication Number:
`
`WO 97/39677
`
`
`
`
`
`(21) International Application Number: PCT/US97/07616|(81) Designated States: European patent (AT, BE, CH, DE, DK,
`ES, FI, FR, GB, GR, TE, IT, LU, MC, NL, PT, SE).
`
`(22) International Filing Date:
`
`21 April 1997 (21.04.97)
`
`(30) Priority Data:
`08/641 ,143
`
`25 April 1996 (25.04.96)
`
`US
`
`Published
`With international search report.
`
`(71) Applicant: THE BOARD OF TRUSTEES OF THE LELAND
`STANFORD JUNIOR UNIVERSITY [US/US]; Suite 350,
`900 Welch Road, Palo Alto, CA 94304 (US).
`
`(72) Inventor: LIM, Kelvin, O.; 270 Parkside Drive, Palo Alto, CA
`94304 (US).
`
`(74) Agent: FLOYD, Mark, B.; 426 Lowell Avenue, Palo Alto, CA
`94301 (US).
`
`(54) Title: PORTABLE MOTOR SYMPTOMS ASSESSMENT DEVICE
`
`
`
`(57) Abstract
`
`including a bradykinesia testing system for
`This invention is a portable device (10) for assessing motor symptoms of a patient,
`measuring reaction and movementtimesof the patient, a tremor testing system for measuring tremors in extremities of the patient, and a
`Tigidity testing system for measuring rigidity in the handof a patient. The rigidity testing system includes a digital shaft encoder (44) with
`a rotatable shaft (24) that is actuated by the patient’s fingers. A microprocessor (46) is connected to the bradykinesia, tremor, and rigidity
`testing systems for computing test results which are stored along with test instructions in an electronic memory (48), which is connected to
`the microprocessor (46). A user interface (16) is connected to the microprocessor (46) for programming in test parameters. The device is
`compactly housed to enable hand carried portability, and an input/output port (20) and printer port (22) are provided for transmitting test
`results to a host computeror printer.
`
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`Zimbabwe
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`Codes used to identify States party to the PCT on the front pages of pamphlets publishing international applications under the PCT.
`Slovenia
`Lesotho
`SI
`Albania
`Slovakia
`Lithuania
`SK
`Armenia
`Austria
`Senegal
`Luxembourg
`SN
`Swaziland
`Latvia
`Australia
`Monaco
`Chad
`Azerbaijan
`Togo
`Republic of Moldova
`Bosnia and Herzegovina
`Barbados
`Tajikistan
`Madagascar
`Turkmenistan
`The former Yugoslav
`Belgium
`Burkina Faso
`Turkey
`Republic of Macedonia
`Mali
`Trinidad and Tobago
`Bulgaria
`Ukraine
`Benin
`Mongolia
`Mauritania
`Brazil
`Uganda
`United States of America
`Malawi
`Belarus
`Mexico
`Uzbekistan
`Canada
`Viet Nam
`Niger
`Central African Republic
`Netherlands
`Yugoslavia
`Congo
`Switzerland
`Norway
`New Zealand
`Cote d'Ivoire
`Poland
`Cameroon
`China
`Portugal
`Romania
`Cuba
`Russian Federation
`Czech Republic
`Sudan
`Germany
`Sweden
`Denmark
`Estonia
`Singapore
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`FOR THE PURPOSES OF INFORMATION ONLY
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`Spain
`Finland
`France
`Gabon
`United Kingdom
`Georgia
`Ghana
`Guinea
`Greece
`Hungary
`Ireland
`Israel
`Iceland
`Ttaly
`Japan
`Kenya
`Kyrgyzstan
`Democratic People's
`Republic of Korea
`Republic of Korea
`Kazakstan
`Saint Lucia
`Liechtenstein
`Sri Lanka
`Liberia
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`WO 97/39677
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`PCT/US97/07616
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`PORTABLE MOTOR SYMPTOMS ASSESSMENT DEVICE
`
`RELATED APPLICATION INFORMATION
`
`This application claims priority from copending U.S. application
`Ser. No. 08/641,143 filed April 25, 1996, which is hereby
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`incorporated by reference.
`
`TECHNICAL FIELD OF THE INVENTION
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`invention relates to the field of motor symptoms
`The present
`assessment, and in particular to a portable electronic device for
`assessing three key motor symptoms of a patient.
`
`BACKGROUND OF THE INVENTION
`
`Many neurological diseases, such as Parkinson's Disease, have
`three key motor symptoms: bradykinesia (slowed voluntary
`movement), rigidity, and tremor. Assessment of these three motor
`symptoms is necessary to determine the progression of the disease
`and to document
`the patient's response to drug administrations and
`other therapies. These three motor symptoms are also associated
`with alcohol and drug withdrawal and must be assessed to document
`the progress of a recovering addict. Further,
`in studies of new
`drugs, researchers must determine what affects the new drugs have
`
`on a patient's motor symptoms.
`
`the assessment of these three motor symptoms must be
`Thus,
`performed for a variety of medical applications.
`The assessment
`should be performed as often as necessary,
`in some cases several
`times per week,
`for precise and accurate tracking of a patient's
`progress. Further,
`the assessment should objectively quantify the
`patient's motor symptoms in a uniform and easily reproducible
`manner .
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`Unfortunately, most of the conventional methods for assessing
`these motor symptoms are not performed objectively.
`Instead,
`assessments are performed subjectively by a trained clinician.
`subjective assessment makes quantifying small changes in the
`clinical state of a patient extremely @ifficult.
`A subjective
`assessment also prevents an effective comparison of test results
`when the results are produced by two different clinicians.
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`the
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`Some progress has been made in developing systems which provide an
`objective assessment of a patient's tremor. U.S. Patent 4,306,291
`issued to Zilm et al. on December 15, 1981, U.S. Patent 4,817,628
`issued to Zealear et al. on April 4, 1989, U.S. Patent 5,265,619
`issued to Colmby et al. on November 30, 1993, and U.S. Patent
`5,293,879 issued to Vonk et al. on March 15, 1994 all disclose
`systems for measuring tremor in a patient.
`Each system includes
`an accelerometer which is strapped to an extremity of the patient.
`The accelerometer produces signals representative of the patient's
`tremor and these signals are then analyzed by a computer to
`produce an objective assessment of the tremor.
`
`Although these systems are effective for objectively measuring one
`key motor symptom,
`tremor, none of these systems has a mechanism
`for measuring the other two motor symptoms, bradykinesia and
`rigidity.
`They are therefore inadequate for assessing all three
`key motor symptoms of a patient.
`Each of these systems suffers
`from the added disadvantage of requiring a trained clinician to
`administer the tremor test. Consequently,
`the patient must visit
`the trained clinician each time a tremor measurement is required.
`As a result,
`these conventional systems for measuring tremor place
`a large travel burden on the patient and consume both the
`patient's and clinician's time for each tremor assessment.
`
`A system for quantitatively assessing all three key motor symptoms
`of a patient is described by Ghika et al. "Portable System for
`Quantifying Motor Abnormalities in Parkinson's Disease",
`IEEE
`Transactions in Biomedical Engineering, Vol. 40, No. 3, March
`1993.
`In Ghika's system,
`three separate test apparatuses are
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`required for measuring the three key motor symptoms. Each of the
`three test apparatuses is connected to a desktop computer equipped
`with an analog interface board.
`The first test apparatus measures
`tremor and includes two solid state accelerometers attached to two
`lucite boards.
`The patient's hand is then sandwiched between the
`two lucite boards so that tremor measurements may be taken.
`
`The
`The second test apparatus is for measuring bradykinesia.
`second test apparatus includes three light bulbs with three
`corresponding buttons placed below the bulbs.
`The bulbs are
`sequentially lit under the control of a computer program and the
`patient moves as quickly as possible to press the corresponding
`button under a newly lit bulb. Reaction times and movement
`times
`of the patient are measured and stored in the computer.
`
`The third test apparatus measures rigidity at the patient's elbow.
`The third test apparatus includes a lucite cradle for holding the
`patient's forearm.
`The lucite cradle is mounted on a metai plate
`with low friction ball bearings so that the clinician may move the
`patient's forearm back and forth. While moving the arm back and
`forth,
`the clinician uses a metronome to try to maintain a
`constant frequency of 0.67 Hz. As the clinician moves the cradle,
`a goniometer measures the angular displacement of the patient's
`forearm and a load cell records the amount of torque applied by
`the clinician to move the cradle.
`The angular displacements and
`applied torques are recorded in the computer for further analysis.
`
`The system described by Ghika has several disadvantages that
`prevent its widespread use. First,
`the system requires a trained
`clinician to administer the three tests to the patient, so that
`the patient must still visit the clinician's office each time a
`motor symptoms assessment is required.
`Second,
`the system
`requires three separate test apparatuses and a desktop computer
`for measuring the three key motor symptoms,
`so that the system is
`not easily portable.
`
`Thus, all of the prior art systems for measuring the motor
`symptoms of a patient require a trained clinician to administer
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`the tests. This requirement severely limits the possible
`frequency of testing and places a large travel burden on the
`patient to continually visit the clinician's office each time a
`motor symptoms assessment is required. Further, none of the prior
`art systems provide a device that combines all three motor
`symptoms tests in one compact and portable unit.
`
`OBJECTS AND ADVANTAGES OF THE INVENTION
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`10
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`In view of the above, it is an object of the present invention to
`provide a device for objectively and quantitatively measuring
`three key motor symptoms of a patient.
`It is another object of
`the invention to provide a motor symptoms assessment device which
`may be operated by a patient with minimal training.
`[It isa
`further object of the invention to package the device in one
`integral unit that is sufficiently compact to enable the device to
`be hand-carried to the home or bed of a patient.
`
`These and other objects and advantages will become more apparent
`after consideration of the ensuing description and the
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`accompanying drawings.
`
`SUMMARY OF THE INVENTION
`
`The invention presents a portable device for assessing three key
`motor symptoms of a patient.
`The portable device includes a
`bradykinesia testing system for measuring reaction times and
`movement times of the patient.
`The bradykinesia testing system
`produces first electrical signals representative of the reaction
`times and second electrical signals representative of the movement
`times.
`The device also includes a tremor testing system for
`measuring a tremor in an extremity of the patient, such as the
`patient's wrist, hand, or foot.
`The tremor testing system
`produces third electrical signals representative of the tremor.
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`The device further includes a rigidity testing system for
`measuring rigidity in a hand of the patient.
`The rigidity testing
`system includes a digital shaft encoder having a rotatable shaft
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`the
`so that when the patient rotates the shaft with their hand,
`Gigital shaft encoder counts a number of rotations of the shaft.
`The digital shaft encoder produces fourth electrical signals
`representative of the number of rotations.
`
`tremor. and
`A microprocessor is connected to the bradykinesia,
`rigidity testing systems for receiving and computing test results
`from the first electrical signals, second electrical signals,
`third electrical signals, and fourth electrical signals.
`An
`electronic memory is connected to the microprocessor for storing
`test instructions and for recording the test results.
`The device
`also has a display for displaying the test instructions and the
`test results.
`
`In the preferred embodiment, a user interface is connected to the
`
`microprocessor for programming the microprocessor with test
`
`parameters relating to the bradykinesia,
`
`tremor, and rigidity
`
`the device has
`testing systems. Also in the preferred embodiment,
`an input/output port and a printer port for transmitting the test
`results to a host computer and a printer, respectively.
`The
`
`entire device is packaged in a housing sufficiently compact
`
`to
`
`allow the device to be hand-carried.
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`BRIEF DESCRIPTION OF THE DRAWINGS
`
`FIG.
`
`1
`
`is a perspective view of a portable device according
`
`FIG.
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`
`FIG.
`
`FIG.
`
`2
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`3
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`4
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`to the invention.
`
`is a top plan view of a user interface of the
`
`portable device of FIG. 1.
`is a perspective view of an accelerometer strapped
`
`to a hand of a patient according to the invention.
`is a perspective view of a portion of the portable
`
`device of FIG.
`
`1 connected to a host computer and a
`
`printer.
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`FIG.
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`5
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`is a schematic block diagram of the portable device
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`GE FIG...
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`FIG.
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`6
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`is a schematic view of a display of the portable
`device of FIG.
`1 displaying user programmable test
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`PCT/US97/07616
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`FIGS. 7 - 8
`
`FIGS.
`
`9
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`- 10
`
`parameters.
`are schematic views of the display of FIG.
`displaying bradykinesia test instructions.
`are schematic views of the display of FIG.
`displaying bradykinesia test results.
`FIGS. 11 - 13 are schematic views of the display of FIG.
`displaying rigidity test instructions.
`FIGS. 14 - 16 are schematic views of the display of FIG.
`displaying rigidity test results.
`is a schematic view of the display of FIG.
`displaying tremor test instructions.
`is a schematic view of the display of FIG.
`displaying tremor test results.
`
`FIG. 17
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`FIG. 18
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`DESCRIPTION
`
`1 - 18.
`A preferred embodiment of the invention is shown in FIGS.
`FIG.
`1 shows a perspective view of a portable device 10 for
`assessing three motor symptoms of a patient. Device 10 has a
`rectangular housing 12 sufficiently compact to enable device 10 to
`be hand-carried. Typically, housing 12 has a length in the range
`of 20 to 30 cm,
`a width in the range of 10 to 20 cm, and a height
`in the range of 5
`to 15 cm.
`In the presently preferred
`embodiment, housing 12 has a length of 24 cm, a width of 15 cm,
`and a height of 8 cm.
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`A display 14 for displaying test instructions and test results is
`recessed in the top surface of housing 12.
`In the preferred
`embodiment, display 14 is a liquid crystal display capable of
`displaying two lines of text having up to twenty characters per
`line.
`In alternative embodiments, other types and sizes of
`displays may be used. Adjacent display 14 is a user interface 16
`for programming device 10 with various test parameters, as will be
`described in the operation section below.
`A top plan view of user
`interface 16 is illustrated in FIG. 2.
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`interface 16 is a keypad having
`In the preferred embodiment,
`twelve function keys for programming device 10.
`The twelve
`function keys are a menu key 28, an item key 30, a field key
`32. an up key 34 ,
`a down key 36, a help key 38. a left
`reaction time key 29, a right reaction time key 31, a left
`finger key 33, a right finger key 35, a both fingers key 37,
`and a tremor key 39.
`The user interface 16 of the preferred
`embodiment is just one example of a suitable interface for
`programming device 10.
`In alternative embodiments, other
`types of user interfaces may be used for programming device
`10, such as switches or buttons.
`The assembly and use of
`such user interfaces are well known in the art.
`
`Referring again to FIG. 1, a right rotatable shaft 24B of a right
`digital shaft encoder is located on the right side surface of
`housing 12.
`A left rotatable shaft 24A (not shown in. FIG.
`2) of a
`left digital shaft encoder is located on the left side surface of
`housing 12. Shafts 24A and 24B are for the patient to rotate
`during a rigidity test, as will be described in the operation
`section below.
`
`A left button 26A, a middle button 26B, and a right button 26C
`are located below interface 16 on the top surface of housing 12.
`Buttons 26A, 26B, and 26C are for the patient to press during a
`bradykinesia test, as will be described in detail in the operation
`section below.
`In the preferred embodiment, buttons 26A, 26B,
`and 26C are LED buttons arranged ina straight line along the top
`surface of housing 12. Both left button 26A and right button 26C
`are spaced an equal distance from middle button 26B.
`In the
`preferred embodiment,
`left button 26A and right button 26C are
`spaced 8
`to 12 cm from middle button 26C, with a preferred spacing
`of 10 cm.
`
`An input/output port 20 and a printer port 22 are located on the
`right side surface of housing 12. Ports 20 and 22 are for
`connecting device 10 to a host computer 54 and a printer 56,
`respectively, as shown in FIG. 4. Also located on the side of
`housing 12 is an accelerometer port 18 for connecting device 10
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`to an accelerometer 60 through an accelerometer connection cord
`62, as shown in FIG. 3.
`Ina particularly advantageous
`embodiment, housing 12 has a compartment {not shown) for storing
`accelerometer 60 and cord 62.
`
`A schematic block diagram of device 10 and its connections to host
`computer 54 and printer 56 is shown in FIG. 5. Device 10
`includes a bradykinesia testing system for measuring reaction
`times and movement
`times of the patient.
`The bradykinesia testing
`system includes buttons 26A, 26B, and 26C, as well as a buzzer 50
`for producing an audible monotone buzzing sound. Buttons 26A,
`26B, and 26C and buzzer 50 are connected to a microprocessor 46.
`
`for
`Each button 26A, 26B, and 26C includes a switch (not shown)
`indicating when each button is depressed by the patient and when
`each button is released by the patient.
`Each button 26A, 26B,
`and 26C further includes an LED for lighting buttons 26A, 26B,
`and 26C under the control of microprocessor 46. Buttons 26A,
`26B, and 26C and their included switches are configured such that
`the pressing and releasing of buttons 26A, 26B, and 26C by the
`patient produces reaction time digital signals representative of
`the patient's reaction times and produces movement
`time digital
`signals representative of the patient's movement
`times. Suitable
`buttons for performing these functions are commercially available
`from Digikey Corporation of Thief River Falls, Minnesota,
`orderable as DigikKey part number EG17151-ND. Specific techniques
`for configuring buttons 26A, 26B, and 26C and their included
`switches in this manner are well known in the art.
`
`Device 10 further includes a tremor testing system for measuring a
`tremor in an extremity of the patient. Referring to FIG. 3,
`the
`tremor testing system includes accelerometer 60 which is strapped
`to a wrist 58 of the patient with a strap 64. Accelerometer 60
`is preferably a light weight,
`three axis accelerometer capable of
`measuring tremor at wrist 58 and producing analog signals
`representative of the tremor.
`Such an accelerometer is
`commercially available from Analog Devices of Norwood,
`Massachusetts, model number ADXL-05-EM-3. Accelerometer 60 is
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`connected to accelerometer port 18 through connection cord 62 such
`that the analog signals produced by accelerometer 60 are
`transmitted to port 18 through cord 62.
`
`Referring again to FIG. 5, port 18 is connected to a high speed
`analog to digital converter 52 for converting the analog signals
`received from accelerometer 60 to tremor digital signals
`representative of the patient's tremor. High speed analog to
`digital converters are commercially available from many electronic
`component suppliers, such as Z World Engineering of Davis,
`California. Converter 52 is connected to microprocessor 46 such
`that microprocessor 46 receives the tremor digital signals from
`converter 52.
`
`Device 10 further includes a rigidity testing system for measuring
`rigidity in both the left hand and right hand of the patient.
`The
`rigidity testing system includes left shaft 24A of a left digital
`shaft encoder 44A and right shaft 24B of a right digital shaft
`encoder 44B.
`Shafts 24A and 24B are configured such that when
`
`left encoder 44A
`shafts 24A and 24B are rotated by the patient,
`counts a first number of rotations of left shaft 24A and right
`
`encoder 44B counts a second number of rotations of right shaft
`24B.
`In the preferred embodiment, encoders 44A and 44B are
`Miniature Panel Mount Optical Encoders model number HRPG-A
`commercially available from Hewlett Packard Corporation of Palo
`
`Alto, California.
`
`Shafts 24A and 24B have a size and shape such that they may be
`easily grasped and rotated by a hand of
`the patient.
`In the
`preferred embodiment, both shaft 24A and 24B are cylinders having
`a length in the range of 2 to 4 cm and a diameter in the range of
`1
`to 2 cm.
`In alternative embodiments, shafts of different shapes
`
`Shafts 24A and 24B have a rotational
`and dimensions may be used.
`resistance sufficiently small such that they may be freely rotated
`by an applied rotational force, such as a force applied by the
`patient's hand. However,
`the rotational resistance is
`sufficiently large to quickly dampen the rotational motion of
`shafts 24A and 24B when the rotational force is removed.
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`Encoders 44A and 44B are capable of counting the first number of
`rotations and the second number of rotations, respectively,
`in
`fractional increments.
`In the preferred embodiment, encoders 44A
`and 44B count shaft rotations with a precision of one sixteenth of
`one rotation.
`Encoder 44A is capable of producing left encoder
`digital signals representative of the first number of rotations
`and encoder 44B is capable of producing right encoder digital
`signals representative of the second number of rotations.
`Encoders 44A and 44B are connected to microprocessor 46 such that
`microprocessor 46 receives the left encoder digital signals and
`the right encoder digital signals.
`
`Microprocessor 46 is programmed to perform various control
`functions related to the operation of the bradykinesia testing
`system,
`tremor testing system, and rigidity testing system, as
`will be described in the operation section below.
`For controlling
`the function of the bradykinesia testing system, microprocessor 46
`is programmed to light up either left button 26A or right button
`26C and simultaneousiy sound buzzer 50 based on the output of a
`random number generation algorithm.
`
`The random number generation algorithm programmed in
`microprocessor 46 produces a first random number corresponding to
`the delay time from the start of a bradykinesia test trial to the
`time that either left button 26A or right button 26C is lit and
`buzzer 50 simultaneously sounded.
`In the preferred embodiment,
`the random number generating algorithm produces delay times in the
`range of 1 to 3 seconds.
`In alternative embodiments,
`the range of
`the delay time may be increased.
`The random number generation
`algorithm also produces a second random number used by
`microprocessor 46 to determine which button 26A or 26C to light
`for each bradykinesia test trial. Microprocessor 46 is further
`capable of timing the pressing and releasing of buttons 26A, 26B,
`and 26C with milliseconds precision.
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`In controlling the functions of the rigidity testing system and
`tremor testing system, microprocessor 46 is capable of timing a
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`rigidity testing period and a tremor testing period.
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`Microprocessor 46 is further capable of sounding buzzer 50 and
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`lighting middle button 26B at the start and the end of both the
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`rigidity testing period and the tremor testing period.
`microprocessor capable of performing the control functions
`described is the Little Star model number 101-0092 commercially
`available from Z World Engineering of Davis, California.
`In the
`
`preferred embodiment, microprocessor 46 is programmed to perform
`the described control functions using C programming language.
`
`Specific techniques of programming a microprocessor to perform
`these control functions for the bradykinesia testing system,
`
`tremor testing system, and rigidity testing system are well known
`in the art.
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`Microprocessor 46 is connected to user interface 16 such that
`microprocessor 46 can be further programmed with test parameters
`relating to the bradykinesia testing system,
`tremor testing
`system, and rigidity testing system.
`In the preferred embodiment,
`the bradykinesia test parameters correspond to a desired number of
`practice trials and a desired number of test trials.
`The rigidity
`and tremor test parameters correspond to a desired rigidity test
`period and a desired tremor test period, respectively.
`Microprocessor 46 is further connected to an electronic memory 48
`such that electronic memory 48 records test results computed by
`microprocessor 46, as will be described in detail in the operation
`section below.
`
`Test instructions relating to the bradykinesia testing system,
`tremor testing system, and rigidity testing system are stored in
`memory 48. Memory 48 is connected to display 14 through
`microprocessor 46 such that the test instructions and test results
`are displayed on display 14.
`Input/output port 20 and printer
`port 22 are connected to microprocessor 46 such that the test
`results computed by microprocessor 46 are transmitted through
`ports 20 and 22 to host computer 54 and printer 56, respectively.
`In the preferred embodiment, device 10 is powered by a DC battery
`(not shown).
`In an alternative embodiment, device 10 receives
`
`power from a conventional electrical wall outlet
`
`(not shown).
`
`11
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`13
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`13
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`WO 97/39677
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`Specific techniques for supplying power to a portable electronic
`device are well known in the art.
`
`The operation of the preferred embodiment is illustrated in FIGS.
`1-18.
`To program microprocessor 46 with test parameters related
`to the bradykinesia, rigidity, and tremor testing systems, a user
`pushes menu key 28 of interface 16, as shown in FIG. 2. When menu
`key 28 is pushed. a parameter menu is displayed on display 14, as
`shown schematically in FIG. 6.
`For simplicity of understanding,
`all of the test parameters of the preferred embodiment are shown
`in FIG. 6. However, because display 14 shows only two lines of
`text at one time,
`the user scrolls through the test parameters
`shown in FIG.
`6 by pressing item key 30 of interface 16.
`
`The first test parameter displayed is a number of test trials 70
`desired for the bradykinesia test.
`In the preferred embodiment,
`number of trials 70 entered by the user 1s ten, as ten trials is a
`sufficiently large sample size to adequately assess the patient's
`reaction time and movement
`time.
`In alternative embodiments,
`the
`user may enter a different number of trials 70 based on a
`different desired sample size.
`To enter the number of test trials
`70,
`the user presses field key 32 to move the display cursor to
`numeric field 71.
`
`The user then presses either up key 34 or down key 36 until
`numeric field 71 contains the desired value of ten.
`Each time the
`user presses up key 34,
`the value of numeric field 71 is increased
`by one. Each time the user presses down key 36,
`the value of
`numeric field 71 is decreased by one. Once the user has set
`numeric field 71 to the desired value of ten, he presses item key
`30 to scroll to the next test parameter, a number of practice
`trials 72.
`
`The user programs number of practice trials 72 and each remaining
`test parameter in an manner analogous to the programming of number
`of test trials 70.
`In the preferred embodiment,
`the users enters
`two practice trials 72 in numeric field 73.
`The user then presses
`item key 30 to scroll to the next test parameter, a rigidity test
`
`10
`
`wna
`
`20
`
`30
`
`35
`
`12
`
`14
`
`14
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`WO 97/39677
`
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`
`period 74, abbreviated on display 14 as "ROTATE (SEC)". After
`entering rigidity test period 74 as 15 seconds in numeric field
`75,
`the user scrolls to the next test parameter, a tremor test
`period 76, abbreviated on display 14 as "TREMOR (SEC)".
`In the
`preferred embodiment,
`the user sets numeric field 77 corresponding
`to tremor test period 76 equal
`to 20 seconds.
`
`The next test parameter is an end pause 78 which corresponds to a
`desired pause between the end of one bradykinesia test trial and
`the start of a subsequent test trial.
`In the preferred
`embodiment,
`the users sets numeric field 79 corresponding to end
`pause 78 equal to 1000 milliseconds.
`The user then scrolls to the
`last test parameter of the preferred embodiment, an instruction
`time 80.
`Instruction time 80 corresponds to the period of time
`that each two lines of test instructions are displayed on display
`
`14 before the next two lines of test instructions are displayed.
`In the preferred embodiment,
`the user sets numeric field 81
`corresponding to instruction time 80 equal
`to 3000 milliseconds.
`After programming each of the test parameters,
`the user presses
`menu key 28 to exit the parameter menu.
`
`10
`
`20
`
`It is to be understood that the preferred values of the test
`parameters described above only illustrate one of many possible
`embodiments.
`The user may program different values for the test
`parameters that are specifically tailored to the patient's needs.
`Further,
`the test parameters are stored in memory 48 so that the
`user need not program all of the test parameters before every
`motor symptoms assessment.
`The user only needs to program the
`test parameters when he or she desires to change one or more of
`
`30
`
`the test parameters.
`
`35
`
`the
`To perform the bradykinesia test on the patient's left hand,
`user presses left reaction time key 29. When key 29 is pressed,
`left hand bradykinesia test instructions 82 are displayed, as
`shown in FIG. 7.
`In the example of the preferred embodiment,
`instruction time 80 is set to three seconds so that each two lines
`of text is displayed for three seconds before the next
`two lines
`of text are displayed. Test instructions 82 instruct the patient
`
`13
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`WO 97/39677
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`
`The
`to use his left index finger to hold down the lit button.
`patient is then instructed to press the newly lit button upon
`hearing buzzer 50.
`The patient is then informed that the first
`two buzzes are for practice and that the next
`ten buzzes are for
`the bradykinesia test. Finally,
`the patient is reminded to use
`his left index finger.
`
`the lit button at the start of each
`In the preferred embodiment,
`bradykinesia practice trial and test trial is middle button 26B.
`When the patient holds down middle button 26B to start the first
`practice trial,
`the random number generation algorithm of
`microprocessor 46 produces the first random number corresponding
`to the delay time and the second random number corresponding to
`which button 26A or 26B to light at the end of the delay time.
`For example, according to one possible outcome of the random
`number generation algorithm, microprocessor 46 delays 2.6 seconds
`and then lights left button 26A and simultaneously sounds buzzer
`50. Upon seeing left button 26A lit and hearing buzzer 50,
`the
`patient moves his left index finger as quickly as possible to
`release middle button 26B and press left button 26A.
`
`the switch
`As the patient releases middle button 26B,
`corresponding to middle button 26B is moved from a closed position
`to an open position, producing left hand reaction time digital
`signals representative of
`the patient's left hand reaction time.
`As the patient presses left button 26A,
`the switch corresponding
`to left button 26A moves from an open position to a closed
`position, producing left hand movement
`time digital signals
`representative of the patient's left hand movement time.
`Microprocessor 46 receives the left hand reaction time digital
`signals and left hand movement
`time digital signals. This
`The
`completes a first practice trial of the bradykinesia test.
`second practice trial and ten test trials are performed in an
`analogous manner.
`
`To perform the bradykinesia test for the patient's right hand,
`user presses right hand reaction time key 31. When key 31 is
`pressed, display 14 displays right hand bradykinesia test
`
`the
`
`wn
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`14
`
`16
`
`16
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`WO 97/39677
`
`PCT/US97/07616
`
`The right hand bradykinesia
`instructions 84, as shown in FIG. 8.
`test is performed in a manner analogous to the left hand
`bradykinesia test, except for the patient using his right index
`finger rather than his left index finger to perform the right hand
`bradykinesia test.
`
`After the left hand bradykinesia test has been completed,
`microprocessor 46 computes left hand bradykinesia test results 86
`from the received left hand movement
`time digital signals and left
`hand reaction time digital signals. Test results 86 are recorded
`in memory 48 and displayed on display 14, as shown in FIG. 9.
`Test results 86 include a left mean reaction time 88. a left
`reaction time s

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