EP2456350A1 - Dispositif de traitement des acouphènes - Google Patents

Dispositif de traitement des acouphènes

Info

Publication number
EP2456350A1
EP2456350A1 EP10730812A EP10730812A EP2456350A1 EP 2456350 A1 EP2456350 A1 EP 2456350A1 EP 10730812 A EP10730812 A EP 10730812A EP 10730812 A EP10730812 A EP 10730812A EP 2456350 A1 EP2456350 A1 EP 2456350A1
Authority
EP
European Patent Office
Prior art keywords
frequency
eeg
tinnitus
therapy
alpha
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Withdrawn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
EP10730812A
Other languages
German (de)
English (en)
Inventor
Armin Bernhard
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.)
Individual
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 EP2456350A1 publication Critical patent/EP2456350A1/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Withdrawn legal-status Critical Current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
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/389—Electromyography [EMG]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/12—Audiometering
    • A61B5/128—Audiometering evaluating tinnitus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F11/00—Methods or devices for treatment of the ears or hearing sense; Non-electric hearing aids; Methods or devices for enabling ear patients to achieve auditory perception through physiological senses other than hearing sense; Protective devices for the ears, carried on the body or in the hand
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N2/00—Magnetotherapy
    • A61N2/004—Magnetotherapy specially adapted for a specific therapy
    • A61N2/006—Magnetotherapy specially adapted for a specific therapy for magnetic stimulation of nerve tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N2/00—Magnetotherapy
    • A61N2/02—Magnetotherapy using magnetic fields produced by coils, including single turn loops or electromagnets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7203—Signal processing specially adapted for physiological signals or for diagnostic purposes for noise prevention, reduction or removal
    • A61B5/7207—Signal processing specially adapted for physiological signals or for diagnostic purposes for noise prevention, reduction or removal of noise induced by motion artifacts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N2/00—Magnetotherapy
    • A61N2/002—Magnetotherapy in combination with another treatment

Definitions

  • the tinnitus problem is therefore to be regarded as very complex, because the ear noises occur in different forms (duration, nature of the sound) and beyond the reaction of the affected person to the sounds is highly individual (from a mild disorder to the absolute unbearable.). So far, especially drug-based procedures and infusions are used, which usually only have a positive effect in the acute tinnitus stage.
  • Other adjuncts include psychological procedures (e.g., behavioral therapy, education), acoustic masking (e.g., with a hearing aid noise generator), various methods of relaxation, and alternative methods such as exercise therapy. Electrostimulation established.
  • the invention includes the development of a technically optimized diagnostic (Cermag) and therapy device (Certis) for tinnitus sufferers for the reduction or suppression / suppression of tinnitus noise based on the diagnostic (Cermag) and therapy device (Certis) for tinnitus sufferers for the reduction or suppression / suppression of tinnitus noise based on the diagnostic (Cermag) and therapy device (Certis) for tinnitus sufferers for the reduction or suppression / suppression of tinnitus noise based on the
  • Cermag is based on a quantitative EEG (Q-EEG), where the derivation is limited to a few application-specific electrode types.
  • Q-EEG quantitative EEG
  • Electroencephalography With Q-EEG, the Fourier transform of the received signals is evaluated, thus making a spectral analysis.
  • the low-field transcranial magnetic stimulation leads to a change in the Q-EEG signature dependent on frequency and direction.
  • the therapy device Certis consists of a head and a base part. On the Headboard areas of the head, especially the inner ear, auditory nerve, auditory pathway, nuclei and parts of the brain and / or the spine or parts of the spine with a low-frequency electrical and / or
  • Electromagnetic field stimulated in the frequency range determined by the Q-EEG via applicators iron core coils.
  • This therapy device is also characterized by the fact that it provides not only the magnetic field stimulation signals but also a high-resolution playback unit for special purposes
  • the therapy device also has a control unit. With the help of the control unit, the person concerned operates the device. Due to the product's features, the device enables people who are suffering from tinnitus to return to public professional and private life.
  • the Certis device also has both a mobile protocoller storage medium and its own data storage medium for the individualized parameters.
  • the head part - stimulator - consists of a "foam cube", in which the head is placed for the therapy.In the head part the stimulation coils (applicators) for the magnetic field are integrated.
  • the derivation of the brain activity is carried out according to the international 10-20 system by means of an electrode cap (Electro Cap Co. USA).
  • an electrode cap Electro Cap Co. USA
  • silver chloride electrodes are used.
  • the amplified and filtered analog signals are converted into digital signal sequences.
  • the sample rate determines how often the analog signal is quantized per second.
  • the digital signal sequences are stored continuously on a recording system.
  • the records of the EEG data are stored in an electrically and soundproofed room.
  • the examination is carried out with relaxed sitting in the chair subjects.
  • the registration of the brain activity takes place under the conditions eyes open and eyes closed over a period of in each case at least 10 minutes. Over a period of at least 10 minutes, the registration of brain activity takes place under the conditions eyes open and eyes closed.
  • Electrode artifacts that can occur when the scalp-to-electrode contact is unstable or the electrodes are poorly attached to the head) Affected epochs (visual inspection), the frequency analysis (Fast Fourier Transformation) over 19 real electrode positions using 2 s data epochs in real time.
  • the representation of the EEG data is ultimately in the form of brain maps, power spectra and in numerical form.
  • the statistical evaluation of the EEG data is done by means of the StatView program.
  • the stored raw data can be subsequently converted into each reference assembly by means of corresponding differences and presented with an average reference. Based on the stored raw data, these transformations can subsequently be carried out arbitrarily and arbitrarily often with one and the same EEG section.
  • the decomposition of the EEG into the classical frequency bands (2-4Hz (delta), 4-7Hz (Theta), 8-13 Hz (alpha), 14-21 Hz (beta), 22-64 Hz (gamma) in lhz bands, as well as Brain Maps rendering, allow visual presentation of information hidden in the background activity.
  • tinnitus is audiometrically and psychometrically limited. Therefore, we asked us whether tinnitus can detect typical changes in the quantitative EEG and, if necessary, these changes can be used as the basis for a therapy application and to check its success.
  • the calculation and representation as quantitative EEG shows the relative and absolute distribution of individual frequency spectra as brain mapping or as power spectrum.
  • tinnitus patients Tinnitus-related changes in total energy and tinnitus-typical signals in their percentage frequency.
  • the average total energy level was significantly reduced in male tinnitus patients compared to the control group, whereas it was significantly increased in female patients.
  • the changes mainly affect the alpha and theta band, the delta band less, and the alpha and beta band in the female group.
  • the data collected allowed a score to be generated on the basis of the percentage distribution, including the changes in overall power, to determine the likelihood of tinnitus.
  • Neurofeedback as a treatment method that acts on the specific location-specific change of the frequency distribution pattern presupposes the exact knowledge of the typical tinnitus-related EEG changes.
  • Successful neurofeedback can be seen in the quantitative EEG as well as in evaluation by tinnitus questionnaire according to Goebel and Hiller, by means of SCL90R questionnaire and BDI questionnaires.
  • the low-field transcranial magnetic stimulation leads to a change in the EEG signature, dependent on frequency and direction. Their positive or negative impact is evidenced by a quantitative EEG study. Their success is verifiable as well as neurofeedback by quantitative EEG and questionnaire according to Goebel and Hiller, SCL90R questionnaire and BDI questionnaire.
  • QEEG data allow therapies to be reviewed while at the same time providing the basis for the application of magnetic therapy or neurofeedback.
  • they allow the application-related EEG diagnostics in tinnitus to limit the derivation of fewer types of electrodes.
  • EEG data can be calculated and graphically displayed in the form of maps (EEG map or spectral parameter map).
  • maps EEG map or spectral parameter map.
  • the registration of the EEG's done according to the demand of the German Society for Clinical Neurophysiology with 19 positions of the 10-20 system and is stored electronically. After visual inspection, the FFT of the artifact-free EEG epochs takes place.
  • the EEG data are presented in the form of brain maps, power spectra and numerics.
  • the power values are calculated for the frequency ranges: Delta (0.5 - 4 Hz), Theta (4 - 7 Hz), Alpha (8 - 13 Hz) and Beta (14 - 21 Hz) and Gamma (22 - 64 Hz) , In Fig. 3 the effectiveness is illustrated by means of a case study:
  • Sex male, age: 55 years, tinnitus duration: 38 months, tinnitus bilateral
  • the associated brain map is shown graphically in FIG. 4, the power spectrum in FIG. 5.
  • the computer - aided evaluation of the EEG data provided evidence that frequency - controlled magnetic fields induce frequency - dependent changes in the brain wave pattern of tinnitus patients.
  • Tinnitus is detectable in the QEEG.
  • FIGS. 8 and 9 show different effects (positive / negative) on the EEG of different persons.
  • Tinnitus typical signals can be detected and are the prerequisite of an individual therapy. Tinnitus therapies are verifiable in their success with this diagnostic (FIG. 10).
  • a field strength of 5 ⁇ T has been used successfully.
  • the frequency of the pulsations is in particular between 1 and 100 Hz. This system allows us to individually control the frequency of the magnetic field.
  • the effects of the pulsating magnetic fields are represented by means of a power spectrum, brain maps and a CSA.
  • Beta 14-21 Hz low gamma (30 - 42 Hz)
  • the goal is to develop objective diagnostic tests for tinnitus that are cost-effective, simple and fast.
  • a stimulus such as a sound or sound
  • brain waves oscillate at a frequency of 40 Hz. This is also referred to as gamma-band activity. This activity is only present during the excitation, ie during the sound or noise. If someone is constantly experiencing tinnitus, gamma-band activities should be constantly in the auditory area of the cortex. The louder the tinnitus, the higher auditory activity should be present.
  • EEG device gamma-band measurements are made that objectively detect tinnitus in its presence and volume.
  • a second effort is to observe brain activity using magnetic resonance imaging (fMRI) techniques and attempt to match the resulting magnetic resonance images to the presence and / or intensity of tinnitus.
  • fMRI magnetic resonance imaging
  • Tinnitus typical signals can be detected and are the prerequisite for individual therapy. Tinnitus therapies are verifiable in their success with this diagnostic. b. Therapy device Certis
  • Copy protection Content not downloadable from the device, watermarking capable (Frauenhofer system), but no DRM 10-capable copy protection 13. Own data format! Data automatically deletes when the subscription expires
  • Compliance control the frequency and timing of hearing can be determined retrospectively, the built-in meter can be used to log the monitoring of the music by day and hour, identification of patient parameters by means of which an individual adjustment of the device parameters can be made.
  • the graphic display with a touchscreen overlay is very similar to a well-known "IPod.”
  • the device is digitally protected except by disassembling the integrated memory chip on which the data is located, or by cutting the headphone cable (! Analog copy!), As no common interfaces for PC's are used and the data file format of music raw data is not a common file format.
  • MicroSD card pluggable; File system FAT16 / 32 (PC compatible);
  • microSD card for a log file (application times, duration, etc.)
  • Microchip signal processor (dsPIC33F, up to 40MIPS)
  • the operating software (hardware driver) is written in C (microchip compiler), with additional libraries.
  • the operating time per battery pack can only be determined after practical tests; Expected to be reachable> 50h. Of course, compatible batteries can be used if required, since the voltage transformer from IV
  • the SD card library is already enhanced for SDHC compatibility; With this, for example, with a 16GB microSD card, it is possible to record about 1200 minutes at 48kHz / stereo (there are also larger cards!). A headboard is designed to meet the specific needs of the application. The following points should be considered:
  • the headboard will be able to adapt to the different head shapes and sizes. Due to the special construction of the head part, the applicator will be positioned much more accurately at the desired location, e.g. at the mastoid. However, during development it is possible to work out the possibility of stimulating other places on the head.
  • the headboard must have a high wearing comfort. It should be tested, if a covering of the ears makes sense.
  • BEAM Brain Electrical Activity Mapping
  • FIGS. 12-17 show further possible head part developments.
  • Fig. 12 shows: The entire headband is equipped with a snap button strip.
  • the therapy element is attached to the ideal height on the bracket and can also be extended in the longitudinal direction.
  • Fig. 13 shows:
  • the headband is a rail system with several locking positions on which the therapy element can be vertically adjusted in height.
  • the therapy element can also be pushed apart horizontally and thus extended to achieve the ideal site of action on the head.
  • Fig. 14 shows: A transverse bar with the two therapy elements is attached to a headband with a rail system.
  • the bracket along the rail can be moved vertically and the therapy elements themselves can be pushed horizontally along the crossbar to the appropriate position.
  • Both headband and crossbar can be resized.
  • Fig. 15 shows: The two therapy elements are attached to the right and left of an elastic headband. The elements can go along one attached to the headband outside loop at several positions.
  • Fig. 16 shows: The two therapy elements are located on the right and left within an elastic headband.
  • the headband can be opened on the inside to hang the elements in different positions.
  • Fig. 17 shows: The therapy element is attached to an ear clip, which is placed outside on the auricle.
  • the bobbin case is attached to a pivotable arm for vertical adjustment.
  • the arm is also extendable for horizontal position adjustment.
  • the new device will be operable via three "push-buttons", the functions are visible on an LCD display.
  • Menu navigation There will be several programs to choose from. The control menu will perform the user.
  • Timer & Compliance Monitor Time recording and control system for reminder and easy use, with the aim of reducing the times to the minimum necessary. Identification of patient parameters by means of which an individual adaptation of the device parameters can be made.
  • Design A functional-aesthetic design is designed to increase the technical competence and credibility of the device.
  • Packaging A combination of suitable transport packaging with a product packaging (such as a casket) that is optimal for the therapy program will be used.
  • rhythmic sound of the drum is a fundamental instrument for triggering and maintaining the shamanic state of consciousness. Examining the effect of regular, monotonous drumbeat on EEG patterns, researcher Andrew Neher noted that rhythmic beats dramatically alter brainwave activity. Other observers of shamanic rituals have found that drumming frequencies in the theta range prevailed during initiation rites.
  • Low-frequency deep stimulation is more sustainable and can lead to therapeutic effects.
  • One of the decision criteria should be the audiogram, but if the person has no serious hearing loss, then what? Do you then take notes from the tactile area or do you focus on what is pleasing to the patient or whether the offered music, which underlies the notes, does not bother too much?
  • the remedy is an otoacoustic measurement.
  • the therapy device and the diagnostic device can use all possible stimulation signal patterns to optimize the QEEG results, especially in electromagnetic or electrical stimulation. There are no limitations on the desired and possible waveform that can be used to stimulate.
  • the protection of the Certis & Cermag system also includes the evaluation and optimization by QEEG of all other different stimulation methods known to us, e.g. also audiovisual or visual, thermal, with laser & vibrating systems stimulation optimization enabled with Certis & Cermag.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Physics & Mathematics (AREA)
  • Biophysics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Acoustics & Sound (AREA)
  • Medical Informatics (AREA)
  • Radiology & Medical Imaging (AREA)
  • Surgery (AREA)
  • Audiology, Speech & Language Pathology (AREA)
  • Pathology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Neurology (AREA)
  • Multimedia (AREA)
  • Otolaryngology (AREA)
  • Psychology (AREA)
  • Vascular Medicine (AREA)
  • Magnetic Treatment Devices (AREA)

Abstract

L'invention porte sur un dispositif pour le traitement des acouphènes à l'aide d'un appareil EEG, en particulier d'un appareil Q-EEG, ainsi qu'une partie de tête, qui comprend au moins un applicateur, lequel produit un champ magnétique basse fréquence dans la gamme de fréquence de 1 à 100 Hz, pour une intensité du champ inférieure à 20 mT.
EP10730812A 2009-07-22 2010-07-15 Dispositif de traitement des acouphènes Withdrawn EP2456350A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102009034491 2009-07-22
PCT/EP2010/060256 WO2011009807A1 (fr) 2009-07-22 2010-07-15 Dispositif de traitement des acouphènes

Publications (1)

Publication Number Publication Date
EP2456350A1 true EP2456350A1 (fr) 2012-05-30

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ID=42988469

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EP10730812A Withdrawn EP2456350A1 (fr) 2009-07-22 2010-07-15 Dispositif de traitement des acouphènes

Country Status (3)

Country Link
US (1) US20120203130A1 (fr)
EP (1) EP2456350A1 (fr)
WO (1) WO2011009807A1 (fr)

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WO2024170425A1 (fr) 2023-02-15 2024-08-22 Vv Analytics Système et procédé de traitement de l'acouphène par biorésonance

Also Published As

Publication number Publication date
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WO2011009807A1 (fr) 2011-01-27

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Effective date: 20170201