EP1453418A1 - Dispositif de test portatif pour etablir la classification du degre de gravite d'une encephalopathie - Google Patents

Dispositif de test portatif pour etablir la classification du degre de gravite d'une encephalopathie

Info

Publication number
EP1453418A1
EP1453418A1 EP02795114A EP02795114A EP1453418A1 EP 1453418 A1 EP1453418 A1 EP 1453418A1 EP 02795114 A EP02795114 A EP 02795114A EP 02795114 A EP02795114 A EP 02795114A EP 1453418 A1 EP1453418 A1 EP 1453418A1
Authority
EP
European Patent Office
Prior art keywords
light
handset
frequency
stimulus
glasses
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP02795114A
Other languages
German (de)
English (en)
Inventor
Dieter Häussinger
Gerald Kircheis
Hans-Achim Rood
Peter Hering
Helmut Blum
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
BLUM, HELMUT
HAEUSSINGER, DIETER
Hering Peter
Kircheis Gerald
Rood Hans-Achim
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of EP1453418A1 publication Critical patent/EP1453418A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/16—Devices for psychotechnics; Testing reaction times ; Devices for evaluating the psychological state
    • A61B5/161—Flicker fusion testing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B3/00—Apparatus for testing the eyes; Instruments for examining the eyes
    • A61B3/02—Subjective types, i.e. testing apparatus requiring the active assistance of the patient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/16—Devices for psychotechnics; Testing reaction times ; Devices for evaluating the psychological state
    • A61B5/163—Devices for psychotechnics; Testing reaction times ; Devices for evaluating the psychological state by tracking eye movement, gaze, or pupil change

Definitions

  • the present invention relates to a method or a measuring system for the quantitative determination of hepatic encephalopathy or other brain disorders.
  • the degree of severity of encephalopathy in the case of acute or chronic liver damage or other brain disorders can be determined by means of a flicker and / or fusion frequency.
  • It is a miniaturized, portable, off-grid measuring device that can be used on site, i. at the bedside, can be used. In this case, the presentation of a stimulus light and the determination of the corresponding cut-off frequencies can take place both via headgear glasses and other types of portable spectacle systems (for example video glasses).
  • HE hepatic encephalopathy
  • the ammonia and other neurotoxic substances in the release of HE are attributed a crucial effect.
  • the injured liver fails to detoxify the substances that originate primarily from the intestine and the musculature. Through the liver bypass circuits, these substances enter the systemic circulation.
  • These substances which are mostly toxic to the brain, include ammonia, mercaptans, inflammatory mediators and trace elements such as manganese. These substances can overcome a blood-brain barrier located between the blood and the brain water and trigger a swelling of the astrocytes in the brain alone or together with ammonia.
  • the clinical diagnosis of encephalopathy usually simple clinical or laboratory parameters such as the HE graduation, the blood ammonia value and the time required in a so-called Number connection test applied for evaluation.
  • These findings are assigned to a scale arbitrarily weighted from 0 to 4 for the purpose of graduation.
  • the use of psychometric battery tests objectifies the assessment of mental performance of cirrhotic patients.
  • computer psychometric tests or test batteries must be followed to describe their performance in terms of attention, concentration and cognition, fine motor skills, and response times.
  • techniques such as Magnetic Resonance Imaging (MRI) and Magnetic Resonance Spectroscopy (MRS) are used to obtain localized structural and biochemical information on Vo in the brain being studied. All these methods are very time consuming or require extensive equipment.
  • a further problem is the assessment of the work and performance, in particular the marketability, of patients with HE.
  • computer-psychometric test procedures were found to be unusable in one quarter of the cirrhotic patients examined, in 50% of the patients Restrictions on the driving ability.
  • patients with an alcoholic cause of liver cirrhosis had been assessed as unfit for driving. From this data, no primary increased risk of accident for cirrhotic patients can be postulated.
  • a blanket rejection of the fitness to drive of a patient with cirrhosis of the liver is therefore not justified, since there are no objective methods of examination and objective assessment criteria.
  • Activated states a differentiation between cirrhotic patients with different degrees of severity of HE, corresponding brain performance disorders, and different pathogenesis of cirrhosis is possible. Based on this test, it can be decided whether the patient is capable of working or performing an activity. At the same time, by differentiating the patient based on a threshold frequency, the decision as to the need for therapy can be made.
  • an intrafoveal light stimulation is generated and thus a defined light (wavelength 650 nm, brightness 270 cd / m 2 ) in the range of 25 to 60 Hz in steps of 0.1 Hz both in increasing (fusion frequency) as well as in descending direction (flicker frequency) of the test person specified.
  • the intrafoveal stimulation is ensured by a concave-convex lens system, which directs the accommodation of the eye to a virtual image of the light source 12 meters away.
  • Rapid successive light stimuli give the impression of "flickering." If the "ascending" method, starting at 25 Hz, is selected, the flicker goes off The thus determined critical frequency at which this change of perception occurs is determined several times and the mean value is calculated from the measured values collected (fusion frequency) This measurement process is repeated several times and the mean value calculated (flicker frequency) . These so-called limit values give the visual discrimination capacity measured in the ascending or descending method and thus in the sense of activation theory the instantaneous " Arousal ".
  • CFF flicker frequency
  • the determination of the CFF described in accordance with the invention forms an efficient and objective analytical factor for the quantification of a low-grade HE and brain disorders present.
  • the parallel decrease of CFF with simultaneous increase in psychomotor and mental disorders of cirrhotic patients allows the quantification of HE in the sense of a continuum over a wide range and the differentiation into HE 0, SHE, HE I and HE II.
  • CFF determination can based on the application of a computerized test battery as a definitive standard and a cutoff frequency of 40 Hz between HE 0 and SHE with a high sensitivity and specificity.
  • CFF is also capable of imaging fluctuations induced by therapeutic interventions or by precipitating factors. The results obtained using the methodology presented can be summarized as follows.
  • a differentiation between cirrhotic patients with different degrees of severity of HE, different brain disorders, and different pathogenesis of cirrhosis is possible by detecting the flicker or fusion frequency.
  • Patient is capable of working or performing an activity.
  • the test device forms a self-sufficient, location-independent and time-independent measuring system, - s. Fig. 5.
  • a newly developed, miniaturized and off-grid system is described that can be used as a highly sensitive test device for the clinical determination of the severity of encephalopathy.
  • the device can also be used in patients with chronic or acute liver diseases to continuously check the flicker frequency in the home (miniaturized, portable, off-grid test device, so-called home monitoring) find application.
  • the system is constructed as a miniaturized, portable, off-grid test device. This has essentially been achieved by six measures:
  • the headgear goggles (5.1), with attached observation optics (5.2) and integrated stimulating light source (5.3) with backlight (5.4 / 5.5) replace the otherwise bulky viewing tube. It has been designed so that it can be adapted to any shape of head and face and worn by the patient in any position, without disturbing extraneous light influence.
  • a red light-emitting diode (5.3) with a diameter of 5 mm, which radiates at a dominant wavelength of 650 nm and is operated with constant brightness, serves as a stimulating light source. It is located in the center of a disk (5.4) made of white Delrin, diameter 27 mm, thickness 3 mm. At a distance of 30 mm, centrally behind the circular disc (5.4) and the stimulating light diode (5.3), is a white light diode (5.5) (0 5mm) for the backlight attached.
  • the optics of the goggles (5.2), ie the focal length of the lenses (5.6) and their distance from the red LED (5.3) (light emitting diode) are designed so that the subject's eyes are "far-off" and have an intrafoveal irritation. So only an irritation of the cones of the retina, is guaranteed.
  • the optical conditions of the glasses (5.1) are thus directly comparable with devices that use a researchertubus.
  • Another option in the design of the glasses is that the diodes are arranged per eye. In this case, they can be installed at a short distance of 0.5 to 6 cm, preferably 1 to 5 cm, and more preferably 1 to 3 cm from the eye.
  • the use of other types of portable glasses systems or even a video glasses (eye-track glasses) is also here considered.
  • a device of this construction allows the immediate use of these glasses for continuous monitoring of CFF by patients themselves. Thus, for the first time it is possible to detect impending, life-threatening coma episodes early on and treat them effectively with medication. This gives the device
  • the control of the optics i. Irritation and ambient light generation, as well as all other control and data acquisition tasks is performed by a microcontroller (MC), which is housed in a handy small housing (6) in the form of a remote control, including display (6.1) and controls (6.2 - 6.5).
  • MC microcontroller
  • the headband glasses (Fig. 5.1) and the handset (6) are connected to each other via a thin, flexible, 3-core cable (5.7).
  • the operating element for the patient is a hand button (7), which is also connected via a thin, flexible, two-core cable (7.1) to the handset.
  • control and data acquisition / transmission instead of over cable bidirectional wireless, z. B. via a 2.4GHz Bluetooth wireless connection between handset / glasses or handset / PC or via radio transceiver in the 433MHz frequency band.
  • control and data acquisition / transmission can also be done optically via infrared interfaces between handset / glasses or handset / PC. It should be noted that in a wireless communication and the Patient button (7) has a unidirectional transmission module in the form of a Bluetooth, - 433er - or infrared connection.
  • the stimulus light and ambient light generation is accomplished by the use of optical fibers between the headgear goggles (5.1) and the handset (6).
  • the headband goggles (5.1) thus eliminates the stimulus light photodiode (5.3) and the photodiode (5.5) for the backlight, as well as the electrical leads. It is thus a full-time electronic decoupling of (5.1) and (6) guaranteed. This makes it possible for the first time to use the method for determining the flicker and fusion frequency in a nuclear magnetic resonance or magnetic resonance tomograph, a magnetoencephalography apparatus or identical apparatuses.
  • Patient data to be recorded are stored by the MC in a nonvolatile memory of the handheld device (6) at the push of a button and can be transferred at any time via an interface (6.6) to RS232 standard or wirelessly to a computer system.
  • the software implemented in the microcontroller generates after switching on the power supply via a miniature slide switch (6.2) and the operation of the red start / stop button (6.3) of the handset (6) a performance frequency at the stimulating light diode (5.3) of the headgear (5) in descending or ascending shape, depending on whether the blue mode button (6.4) of the handset (6) was pressed simultaneously with the start / stop button (6.3) or not. Simultaneous pressing of the Start / Stop button (6.3) and the mode button (6.4) produces an ascending performance frequency from 20Hz to 62.5Hz in steps to 0.1 Hz. Pressing the Start / Stop button (6.3) alone produces a descending performance frequency, starting at 62.5Hz to 20Hz in 0.1Hz increments. In both cases, pressing the Start / Stop button ( 6.3) the background lighting (5.4 / 5.5) (white LED) is switched on.
  • the current frequency is displayed on the display (6.1) of the handset (6).
  • the frequency change routine is exited and waited to see if the. current frequency value by pressing the yellow memory button (6.5) in the memory of the handset (6) is to write or a new measurement, by pressing the Start / Stop button (6.3) to start. This process can be repeated as often as you like.
  • the microcontroller increments the memory location, so that no measured value is lost.
  • the test supervisor has the option of aborting the measuring process, possibly changing the mode and / or starting a new measurement.
  • the microcontroller registers which measurement cycle has been selected by the test conductor in order to be able to make an assignment according to fusion frequencies or after flicker frequencies in the evaluation of the data.
  • the microcontroller transfers the data stored in the memory via the serial interface (6.6) with the corresponding coding of the modes (fusion frequencies: VF or flicker frequencies: FF) a connected computer.
  • the power supply of the system provides a 9 volt battery or a 9 volt accumulator, which can be charged via the jack socket (6.7) for the patient button (7). Charging is initiated by toggling the slide switch (6.2) from the center (system off) position to the left, while the right switch position means normal (system on) mode.
  • Three 3 mm control LEDs at the top of the handset (6) indicate to the test manager the operating status of the system.
  • the red LED (6.9) indicates whether the system or is switched off.
  • the yellow LED (6.10) indicates the status of the backlight (5.4 / 5.5) and the status of the stimulus light (5.3) is occupied by the green LED (6.11).

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Surgery (AREA)
  • Molecular Biology (AREA)
  • Physics & Mathematics (AREA)
  • Veterinary Medicine (AREA)
  • Biophysics (AREA)
  • Medical Informatics (AREA)
  • Biomedical Technology (AREA)
  • Psychiatry (AREA)
  • Pathology (AREA)
  • Social Psychology (AREA)
  • Psychology (AREA)
  • Hospice & Palliative Care (AREA)
  • Educational Technology (AREA)
  • Developmental Disabilities (AREA)
  • Child & Adolescent Psychology (AREA)
  • Ophthalmology & Optometry (AREA)
  • Measurement And Recording Of Electrical Phenomena And Electrical Characteristics Of The Living Body (AREA)
  • Measuring And Recording Apparatus For Diagnosis (AREA)

Abstract

L'invention concerne un système permettant de surveiller et détecter le cours de troubles de la fonction cérébrale, notamment le cours de l'encéphalopathie hépatique, à l'aide d'une fréquence de scintillement et/ou de fusion des images. Le système présente un dispositif de mesure miniaturisé, portatif, indépendant du secteur qui peut s'utiliser directement sur place. Le système optique d'éclairage prévu pour fournir une lumière de stimulation avec un éclairage d'arrière-plan est mis en oeuvre par l'intermédiaire de lunettes maintenues au niveau de la tête (5,1). La détermination des fréquences seuils correspondantes, la production des impulsions de lumière de stimulation et de la lumière d'adaptation, ainsi que la détection de données et la mémorisation s'effectuent par le biais d'un microprocesseur implémenté dans un appareil de commande portatif (6).
EP02795114A 2001-12-14 2002-12-06 Dispositif de test portatif pour etablir la classification du degre de gravite d'une encephalopathie Withdrawn EP1453418A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE10161676A DE10161676B4 (de) 2001-12-14 2001-12-14 Tragbare Test-Vorrichtung zur Schweregradeinteilung einer Enzephalopathie
DE10161676 2001-12-14
PCT/EP2002/013826 WO2003051199A1 (fr) 2001-12-14 2002-12-06 Dispositif de test portatif pour etablir la classification du degre de gravite d'une encephalopathie

Publications (1)

Publication Number Publication Date
EP1453418A1 true EP1453418A1 (fr) 2004-09-08

Family

ID=7709342

Family Applications (1)

Application Number Title Priority Date Filing Date
EP02795114A Withdrawn EP1453418A1 (fr) 2001-12-14 2002-12-06 Dispositif de test portatif pour etablir la classification du degre de gravite d'une encephalopathie

Country Status (4)

Country Link
EP (1) EP1453418A1 (fr)
AU (1) AU2002361021A1 (fr)
DE (1) DE10161676B4 (fr)
WO (1) WO2003051199A1 (fr)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10485466B2 (en) 2009-03-20 2019-11-26 Cognisens Inc. Device and method for measuring mild perceptual impairment
DE102017008363A1 (de) 2017-09-06 2019-03-07 Helmut Blum Elektro-optische Vorrichtung zur Schweregradmessung einer Hepatischen Enzephalopathie

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2222524A (en) * 1988-09-12 1990-03-14 Jimbo Engineering Corp Flicker-fusion apparatus
DE9308390U1 (de) * 1992-06-05 1993-10-21 Haberl, Stephanie, 85622 Feldkirchen Vorrichtung zur Bestimmung der Flimmerverschmelzfrequenz
JPH0856938A (ja) * 1994-08-23 1996-03-05 Seikosha Co Ltd フリッカーテスト装置
JP2001212117A (ja) * 2000-02-07 2001-08-07 Univ Kanagawa フリッカー試験器

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO03051199A1 *

Also Published As

Publication number Publication date
AU2002361021A1 (en) 2003-06-30
WO2003051199A1 (fr) 2003-06-26
DE10161676A1 (de) 2003-07-10
DE10161676B4 (de) 2005-05-25

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