EP2398377A1 - Dispositif de test d'impulsion sur tête pour évaluation de la fonctionnalité des canaux semi-circulaires et pour la réhabilitation d'une perte vestibulaire - Google Patents

Dispositif de test d'impulsion sur tête pour évaluation de la fonctionnalité des canaux semi-circulaires et pour la réhabilitation d'une perte vestibulaire

Info

Publication number
EP2398377A1
EP2398377A1 EP09776350A EP09776350A EP2398377A1 EP 2398377 A1 EP2398377 A1 EP 2398377A1 EP 09776350 A EP09776350 A EP 09776350A EP 09776350 A EP09776350 A EP 09776350A EP 2398377 A1 EP2398377 A1 EP 2398377A1
Authority
EP
European Patent Office
Prior art keywords
patient
evaluation
peripheral vestibular
vestibular functionality
test method
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Withdrawn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
EP09776350A
Other languages
German (de)
English (en)
Inventor
Stefano Ramat
Marco Mandala'
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.)
Universita degli Studi di Pavia
Original Assignee
Universita degli Studi di Pavia
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 Universita degli Studi di Pavia filed Critical Universita degli Studi di Pavia
Publication of EP2398377A1 publication Critical patent/EP2398377A1/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Withdrawn legal-status Critical Current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
    • A61B5/103—Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/11—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0219—Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
    • 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
    • A61B3/028—Subjective types, i.e. testing apparatus requiring the active assistance of the patient for testing visual acuity; for determination of refraction, e.g. phoropters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/40—Detecting, measuring or recording for evaluating the nervous system
    • A61B5/4005—Detecting, measuring or recording for evaluating the nervous system for evaluating the sensory system
    • A61B5/4023—Evaluating sense of balance
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6802—Sensor mounted on worn items
    • A61B5/6803—Head-worn items, e.g. helmets, masks, headphones or goggles

Definitions

  • the present invention pertains to the field of medicine and, in particular, it concerns a system as well as a method for the evaluation of the vestibular functionality in a subject.
  • the method of the invention may also be suitably used for the rehabilitation of the peripheral vestibular functionality.
  • Peripheral vestibular pathologies may frequently cause an alteration in the efficiency of the vestibular apparatus. Ethiology may be very different; for instance, infection may cause vestibular neuritis, which may be treated pharmacologically leading to a complete or sometimes partial functional recovery.
  • Benign paroxismal positional vertigo represents a peripheral vertigo syndrome characterized by paroxismal vertigo attacks which are triggered by specific movements of the heads and may last few seconds. It may also occur in case of rapid and sudden movements of the head.
  • Another common pathology is the Meniere's disease, which is caused by an increase in the quantity of endolympha, i.e. the liquid medium wherein both labyrinthine and cochlear receptors are immersed.
  • the symptoms include rotatory vertigo which may have a duration of few hours .
  • Pharmacological treatment may be useful for reducing the sensitivity of the vestibular hair cells, which often result in at least a partial loss, when not even complete.
  • the surgical resection of the vestibular nerve of the affected ear is the only intervention possible.
  • Labyrinthine or perilymphatic fistula defines an anomalous communication between perilymphatic space in the internal ear and the medium ear, due to a defect of the bone labyrinth or to a lesion in the "labyrinthine windows" .
  • Said rotation may achieve angular accelerations of thousands of degrees per square second.
  • An expert physician could detect a refixation saccade, which denotes a rapid and fast movement of the eyes in the direction opposite to head rotation, indicating that a deficit, i.e. a loss of peripheral vestibular functionality, occurred with respect to the same side of the rotation.
  • a deficit i.e. a loss of peripheral vestibular functionality
  • the identification of a vestibular loss or hypofunctionality becomes difficult due to the extreme adaptability of the vestibular and of the ocular motor system, which are able to rapidly learn how to compensate, through adaptive mechanisms or substitution, for the loss of information about the orientation and/or rotation of the head, which is normally activated when semicircular canals are damaged.
  • the "head impulse test” is based on said second law of Ewald and allows to identify a pathological state even when adapting processes have occurred. However, further examinations are required in order to evaluate the functional damages and the resulting functional limits caused. While it has been conceived in order to investigate the functionality of the horizontal semicircular canals, it has then been applied to the other semicircular canal pairs as well.
  • the present invention relates to an apparatus for the evaluation and/or rehabilitation of the peripheral vestibular functionality.
  • the invention in a second embodiment, relates to a test method for the diagnosis of the loss in the peripheral vestibular functionality of each single semicircular canal .
  • the method of the present invention may be used for the rehabilitation of the peripheral vestibular functionality.
  • Fig. 1 shows the structure of the vestibular apparatus; in particular, the three semicircular canals (SCC) , the ampullae and the utricle are indicated.
  • SCC semicircular canals
  • Fig. 2 shows a flow-chart summing up the method of the present invention.
  • FIG. 3 shows the embodiment of the invention relating to the diagnosis of the peripheral vestibular functionality loss.
  • FIG. 4 shows the embodiment of the invention relating to the rehabilitation of the peripheral vestibular functionality.
  • FIG. 5 and 6 show two examples of graphic output, which can be obtained from the method of the present invention.
  • semicircular canal relates to each one of the three single semicircular canals of each vestibular labyrinth (also abbreviated as SCC) : horizontal, superior and posterior.
  • Semicircular canals are provided symmetrically at both sides of the head and, in particular, each of them lies on the same plane of the corresponding opposite canal .
  • Angular acceleration is defined as the rate of change in angular velocity over time and it may be expressed as degrees or radians per squared second (°/s 2 or rad/s 2 ) .
  • Passive movements relate to the movements imposed to the patient's head by the clinician, for instance, bringing the patient's head between hands posed on the temporal-parietal skull bones and turning the head to some extents to the left or to the right around its vertical axis. Accordingly, the patient cannot predict direction, speed nor the angle of the rotation determined by said motion.
  • Active rotation refers to the movement made actively by the patients themselves by rotating the head.
  • Loss is to be intended as the complete loss of the sensitivity of one SCC, which leads to the patient being completely deprived of the vestibular rotational information and thus to the inability to properly stabilize gaze in space and to the impairment of balance.
  • “Hypofunctionality or deficit” instead, relates to any little or severe damage to the gaze stabilization and balance systems caused by deficit in the vestibular apparatus. Damages may occur because of infections, inflammatory events, pathologies, pharmacologic treatment side-effect, accidents or even traumas .
  • opticaltypic line refers to an array of letters on an optotypic chart used for assessing the visual acuity of a patient, such as the Snellen chart, the E
  • Visual target refers to any images, such as drawings, symbols, numbers or letters of different sizes, which the patient is required to recognise and read.
  • a “Sloan's letter” refers to a visual target selected among the capital letters S, O, C, D, K, V, R, H, N or Z.
  • "Rotational angle” is defined as the angle lying on the traverse plane and comprised between the position of a fixed point of the patient's head at the starting position and the position of the same point achieved after the rotation has been imposed. Said angle may be expressed in degrees or in radians. When rotational movements are manually produced, a certain degree of error may occur, such as, for instance ⁇ 5° with respect to the rotational angle declared.
  • an apparatus for the evaluation of the peripheral vestibular functionality of a patient comprises: - a displaying unit (1) ;
  • the display unit (1) showing the letter to be recognised by the patient, is placed at a suitable distance, for instance 50 centimeters, in front of the patient, according to standard clinical procedures .
  • the display unit (1) may be any means suitable for showing a visual target for a period of time in the order of few milliseconds. For instance, it can be a screen on which the visual targets are displayed or projected or it may be a computer monitor.
  • a computer software may govern the selection of the visual target to be displayed, which will be among those above disclosed.
  • the rotational acceleration measuring unit (2) is any device capable of measuring the angular acceleration, in particular, determined by the rotation imparted to the patient's head by the clinician. Accordingly, a gyroscope or two accelerometers may be used, which provide the advantage of being easy to handle.
  • the rotational acceleration measuring unit (2) shall be placed in such a way that it rotates integrally with the patient's head, so that they move together.
  • a helmet may be provided wherein the gyroscope (see, for instance, FIG. 3) or the two accelerometers are fixed thereto. In the case of the accelerometers, they need to be placed on opposite sides of the axis of the rotation (e.g.
  • the measured value of angular acceleration may be acquired by the device itself or, in an alternative embodiment, said unit (2) may be connected to a recording unit (3) directly, which is capable of recording and storing the rotational acceleration data introduced or directly acquired form the unit (2) .
  • the recording unit (3) may be a computer software.
  • the recording unit (3) is also able to record the response of the patient. In fact, once the patient has read and recognised the letter shown, they will communicate it to the clinician, who will introduce said result into the recording unit (3) . Alternatively, the patient themselves may introduce the response into the unit (2) , for instance, with the use of a keyboard in the preferred embodiment, wherein the recording unit (3) is a computer software .
  • the apparatus of the invention may further include an analysing unit (4) .
  • Said analysing unit is connected to the recording unit (3) , so that it can acquire the data on patient's responses to be analysed, and may be connected to the measuring unit
  • the recording unit (3) and the analysing (4) unit may be represented by a computer software.
  • the analysing unit (4) is also connected to the displaying unit (1) , so that it receives information on the letter shown and compares it to the response given by the patient. In particular, when they do correspond, the patient's response will be correct or positive, otherwise it will be wrong or null.
  • the analysis unit (4) is able to analyse the results collected about rotational acceleration and patient's response in each set of experiments and to provide an output, which may be in any suitable forms, such as, signals, tables or graphs, like column graph, wherein the x and y axes report, for instance, the value of rotational acceleration and the frequency of positive results, respectively.
  • the analysing unit (4) may provide an output in the form of signals, visual signal, for instance through the displaying unit (1) or a sound signal, through any suitable means connected thereto, informing, for example, the clinician about the correctness of each response, by comparing the letter shown on the displaying unit (1) and the response of the patient.
  • the present invention concerns a test method, which allows evaluation of the peripheral vestibular functionality.
  • said evaluation is independent from any previous functionality assessment.
  • the method of the invention includes the phases of : a) assessing the static visual acuity of the patient; b) evaluating the dynamic vestibular functionality and collecting the data; c) processing the data and providing an output.
  • phase of the static visual acuity assessment the patient is required, while sitting or standing, to read the letters, such as 5 letters, of an optotypic line on suitably rescaled optotype chart projected onto the displaying unit (1) placed in front of them, usually at a suitable distance comprised for instance between 30 and 120, preferably 50 centimetres, as shown in Fig. 3.
  • the assessed static visual acuity of the patient corresponds to the line whose letters are read and recognised.
  • any optotypic chart may be used, such as those listed above or other chart commonly used in clinical practise.
  • the phase of examination and collection of data includes at least one set of experiments with the aim of evaluating the dynamic visual acuity of the patient.
  • the patient is required to read and recognise a letter shown to them, while the clinician rotates their head imparting a certain rotational acceleration (see, for a general reference, "Principle of the head impulse (thrust) test or Halmagyi head thrust test (HHTT)" F. Wuyts, B-ENT, 2008, 4, Suppl . 8, 23-25).
  • a displaying unit (1) at a distance of between about 30 centimetres and about 120 centimetres, preferably being about 50 centimetres, wearing an helmet to which the rotational acceleration measuring unit (2) is attached, so that said unit (2) moves integrally with the patient's head.
  • the clinician stands, for instance, behind the patient and poses his hands on the temporal-parietal skull bones.
  • the clinician rotates the patient's head to the left or to the right around its vertical axis, thus imposing a certain rotational acceleration.
  • Said acceleration value is measured by the measuring unit (2) and may be recorded by the recording unit ( 3 ) .
  • Said threshold value may for instance determine a 600 degrees/s 2 range of acceptable head acceleration; for example, it can be set to about 1000 deg/s 2 , thereby defining a bin ranging between about 700 and about 1300 deg/s 2 in the course of the first set of experiments, while during the subsequent set the head acceleration may achieve about 1.700-2.300 deg/s 2
  • the letters of the ninth optotypic line For instance, if the patient was able to read the letters of the ninth optotypic line, then during the dynamic test the letters belonging to the eight line, having a larger size, are shown.
  • the appearance time of the letter it may be within 10-30 milliseconds and, preferably, between 15-25 milliseconds from the time when the acceleration of the head reaches the threshold. The patient is required to read and to recognise it and the response is then recorded in the recording unit (3 ) .
  • Step b) follows with a second set of experiments, wherein, in particular, the same conditions above disclosed apply, the only difference being that an higher rotational acceleration is required to be imposed by the clinician to the patient's head. Thresholds may be generally increased in steps of about 1000 deg/s 2 , up to a value of about 7000 deg/s 2 . The patient is again required to recognise and to indicate the letter shown.
  • the experiment is repeated until a statistically significant number of results are collected for said higher rotational acceleration value as well.
  • a number between 10 and 20 automatically adjusted by the analysing unit (4) may provide a sufficient number of samples for establishing a directional asymmetry with p values below 0.05.
  • a third set of experiments may thus be performed, wherein the rotational acceleration of the head of the patient is still increased under the same conditions above disclosed.
  • the last set of experiment required for the evaluation of the dynamic vestibular functionality of the patient will be the one wherein the rotational acceleration imposed by the clinician to the head of the patient is so elevated that they are unable to read and recognise the letter shown on the displaying unit (D .
  • phase c) for the elaboration of the results by the analysing unit (4) follows.
  • the analysis phase may be performed within a suitable software.
  • tables or graphs, such as the ones of FIG. 5 and 6 may be obtained from the results collected during phase b) .
  • the clinician will be able to evaluate the functional performance of the vestibular system.
  • diagnosis may be performed with respect to the functionality of the opposed semicircular canal, in case a lesion involved the vestibular apparatus of one side only, or diagnosis may be made by comparing the results of the experiments with standard tables.
  • saccadic movements it is possible to define range of normality for the relationships between amplitude and duration or between amplitude and peak velocity on the basis of the main sequence (see, as a general reference "Saccadic palsy after cardiac surgery: characteristics and pathogenesis”; Solomon D, Ramat S, Tomsak RL, Reich SG, Shin RK, Zee DS, Leigh RJ. - Ann Neurol.
  • Fig. 5 depicts a column graph showing the trend of the correct trials, i.e. the exact responses given by the patient, at different rotational acceleration both for the left (A) and for the right (B) .
  • the graphs show that the lesion involved the vestibular apparatus of the left side.
  • the present invention relates to a method for the rehabilitation of the peripheral vestibular functionality.
  • the stimulation of the vestibular- ocular reflex allows the improvement of the vestibular function, in particular, when the stimulation occurs with head movement dynamics that are potentiality close to the actual residual capacity of the patient.
  • the rehabilitation experiment includes the steps of : a) evaluating the peripheral vestibular functionality of the patient; b) performing a set of experiments for the increasing the peripheral vestibular functionality of the patient through gain adaptation experiments tailored to the residual functionality of the patient; c) repeating the set of experiments of step b) for a number of times.
  • step b) during each rehabilitation experiment the patient is required to actively rotate the head from left to right (see, for instance, FIG. 4) .
  • a threshold value set by the clinician or by the patient itself according to the clinician's instructions
  • a visual target will appear on the displaying unit (1) for as long as the head velocity of the patient stays above the value reached at threshold acceleration.
  • the patient is again required to read and recognise it .
  • the data concerning the threshold value is set into the analysing unit (4) , which is thus able to govern the displaying of the visual target onto the displaying unit (1) .
  • said threshold value is 500 deg/s 2 above the highest acceleration value at which the patient was still able to read and recognise the letter as per the last set of experiments performed for evaluating the dynamic vestibular functionality.
  • the experiment above disclosed is then repeated for a number of times, which is decided by the clinician according to his experience.
  • the vestibular functionality of the patient may be evaluated with the method according to the present invention, thus providing useful information to the clinician and motivational drive to the patient about the actual improvement achieved.

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Abstract

La présente invention porte sur un système ainsi que sur un procédé d'évaluation de la fonctionnalité vestibulaire chez un sujet. Le système comprend une unité d'affichage destinée à présenter une cible visuelle telle qu'un optotype au patient, un dispositif de mesure de l'accélération rotative qui fait tourner intégralement la tête du patient, et une unité d'enregistrement. Le procédé de l'invention peut également être utilisé de façon appropriée pour la réhabilitation de la fonctionnalité vestibulaire périphérique.
EP09776350A 2009-01-30 2009-01-30 Dispositif de test d'impulsion sur tête pour évaluation de la fonctionnalité des canaux semi-circulaires et pour la réhabilitation d'une perte vestibulaire Withdrawn EP2398377A1 (fr)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/EP2009/000611 WO2010085977A1 (fr) 2009-01-30 2009-01-30 Dispositif de test d'impulsion sur tête pour évaluation de la fonctionnalité des canaux semi-circulaires et pour la réhabilitation d'une perte vestibulaire

Publications (1)

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EP2398377A1 true EP2398377A1 (fr) 2011-12-28

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EP09776350A Withdrawn EP2398377A1 (fr) 2009-01-30 2009-01-30 Dispositif de test d'impulsion sur tête pour évaluation de la fonctionnalité des canaux semi-circulaires et pour la réhabilitation d'une perte vestibulaire

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EP (1) EP2398377A1 (fr)
WO (1) WO2010085977A1 (fr)

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EP2811891A1 (fr) * 2012-02-09 2014-12-17 Universität Zürich Système pour examiner les mouvements oculaires, en particulier le réflexe vestibulo-oculaire et l'acuité visuelle dynamique
CN105960193A (zh) 2013-09-03 2016-09-21 托比股份公司 便携式眼睛追踪设备
US10310597B2 (en) 2013-09-03 2019-06-04 Tobii Ab Portable eye tracking device
US10686972B2 (en) 2013-09-03 2020-06-16 Tobii Ab Gaze assisted field of view control
US9952883B2 (en) 2014-08-05 2018-04-24 Tobii Ab Dynamic determination of hardware
WO2016176287A1 (fr) * 2015-04-27 2016-11-03 University Of Florida Research Foundation, Inc. Application pour smartphone ou dispositifs correspondants pour utilisation dans l'évaluation de la fonction du réflexe oculo-vestibulaire
EP3944812A1 (fr) * 2020-07-27 2022-02-02 Beon Solutions S.r.l. Dispositif et procédé pour la prévention et le traitement du syndrome d'apnée obstructive du sommeil
EP3944811A1 (fr) * 2020-07-27 2022-02-02 Beon Solutions S.r.l. Dispositif et procédé pour la prévention et le traitement de la dyslexie
IT202000020833A1 (it) * 2020-09-01 2022-03-01 Beon Solutions S R L Dispositivo e metodo per la prevenzione ed il trattamento dei disturbi uditivi vestibolari

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WO1999009881A1 (fr) * 1997-08-22 1999-03-04 Massachusetts Institute Of Technology Appareil et procede de mesure du reflexe oculo-vestibulaire
US7500752B2 (en) * 2004-04-28 2009-03-10 Natus Medical Incorporated Diagnosing and training the gaze stabilization system
US8333472B2 (en) * 2004-07-13 2012-12-18 Neuro Kinetics Compact neuro-otologic, neuro-ophthalmologic testing device and dynamic visual acuity testing and desensitization platform

Non-Patent Citations (2)

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Publication number Publication date
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WO2010085977A1 (fr) 2010-08-05

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