Trial document




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  DRKS00014712

Trial Description

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Title

MEG and EEG studies in proof of interaction between auditory and other sensory systems at cortical level

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Trial Acronym

MEG-VES controlled study

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URL of the Trial

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Brief Summary in Lay Language

The medical problem of noise-induced hearing loss resulting in tinnitus is increasing more and more nowadays. Tinnitus is a result of excessive noise pollution. Affected people hear a subjective noise such as humming, ringing or hissing. It can occur in stages or permanently. People concerned suffer especially from a restricted quality of life. So far, there are only limited therapeuthic concepts to help patients.
It is assumed that different human sensory systems interact with each other. During our studies it is to be tested, if stimulating the vestibular organ affects the processing of acoustic stimuli. The study includes 25 patients and a control group of 25 normal hearing people as well. Via caloric stimulation using warm water, the vestibular organ is to be tested. Using beeps should help to find out wether the stimulation of the vestibularorgan has an effect on the auditory system and wether the acoustic stimulation will be suppressed. Stimulation of the median nerve is used as a control stimulation. We expect it to be the same in both patient group and control group.
The measurements on cortical level are carried out by means of measurement techniques MEG and EEG. The vestibular organ is stimulated by warm water (44 degrees Celcius), measurement durating is five minutes. Afterwards the cortical answers to acoustic stimulation and to stimulation of the median nerve are measured.
It is to be verified long-term, if there are starting points that can have a preventive positive impact on the pathological listening perception.

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Brief Summary in Scientific Language

It is assumed that different human sensory systems interact with each other, either by direct neuronal connections or by claiming resources of one`s own.
The influence of stimulation of the vestibular organ on the cortical processing of acoustical stimulation is tested. The intention of the study is it to proof this interaction between the processing of the stimuli of the vestibular organ and the acoustical stimulation. Stimulating the median nerve is used as control stimulation. Using specific measurement technology, MEG and EEG, measurements will take place on cortical level. It will be analyzed whether there will develop changes in the processing of acoustical or sensory stimuli in certain cortex areas after being exposed to caloric stimulation of the vestibular organ.
MEG technology is measuring the electrical activity by external sensors, so-called SQUIDS. Electrical currents by active cortical neurons cause magnetic signals in the human brain. These signals induce electrical voltage in the measuring coil. Using EEG, electrical potential fluctuations of cortical neurons are summed and measured at the head surface. Both techniques can be used to analyze generated event-related potentials or fields of cortical neurons. By means of thermic stimulation equipment we stimulate the vestibular organ by using warm water (44 degrees Celcius) for 30 seconds. Measuring time is five minutes and includes fivefold stimulation of the vestibular organ and subsequent measurement via MEG and EEG. Immediately after the stimulation the cortical answers to acoustic stimuli (beeps) and somatosensory stimuli (stimulation of the median nerve) are measured.
The sample includes 25 patients, suffering either from tinnitus or another noise-induced hearing loss. It is to be confirmed that stimulating the vestibular organ has different effects on auditory perception of patients than on healthy people`s auditory perception, whereas effects based on somatosensory stimulation are the same in both patient and control group. It is to be verified long-term, if there are starting points that can have a positive impact on the pathological listening perception of persons concerned regarding prevention and therapy.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00014712
  •   2018/05/22
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  •   yes
  •   Approved
  •   5495-03/18, Ethikkommission der Friedrich-Schiller-Universität Jena an der Medizinischen Fakultät
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   H93.1 -  Tinnitus
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Interventions/Observational Groups

  •   It is assumed that different human sensory systems interact with each other, either by direcct neuronal connections or by claiming resoures of one`s own.
    The influence of the stimulation of the vestibular organ on the cortical processing of acoustical stimulation. Stimulating the median nerve is used as a control stimulation. Using specific measurement technology, MEG and EEG, measurements will take place on cortical level. It will be analysed wether there will develop changes in the processing of acoustical or sensory stimuli in certain cortex areas after being exposed to caloric stimulation of the vestibular organ.
    MEG technology is measuring the electrical activity by external sensors, so-called SQUIDS. Electrical currents by active cortical neurons cause magnetic signals in the human brain. This signals induce electrical voltage in the measuring coil. Using EEG, electrical potential fluctuations of cortical neorons are summed ans measured at the head surface. Both techniques can be used to analyse generated event-related potentials or fields of cortical neurons. By means of thermic stimulation equipment we stimulate the vestibular organ by using warm water (44 degrees Celcius) for 30 second. Measuring time is five minutes and includes fivefold stimulation of the vestibular and subsequent measurement via MEG and EEG. Immediately after the stimulation the cortical answers to acoustic stimuli (beeps) and somatosensory stimuli (stimualation of the median nerve) are measured.
    The sample includes 25 patients, suffering either from tinnitus or another noise-induced hearing loss. It is to be confirmed that stimulating the vestibualr organ has different effects on auditory perception of patients than on healthy people`s auditory perception, whereas effects based on somatosensory stimulation are the same in both patient and control group. It is to be verified long-term, if there are starting points that can have a positive impact on the pathological listening perception of persons concerned regarding prevention and theerapy. The analyse respectively in multifactorial design with two-tiered factors:group (patients/controll), measuring time point (before/after caloric stimulation) and the type of stimulus (acoustical/somatosensory) by means of generalized estimating equating. The endpoints are the Mean Global Field Power (MGFP) of sensor level, respectively dipols after source reconstruction.
  •   The sample includes 25 patients, suffering either from tinnitus or another noise-induced hearing loss.
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Control group receives no treatment
  •   Prevention
  •   Factorial
  •   N/A
  •   N/A
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Primary Outcome

Purpose and final point of the study is proofing a crossmodal interaction between auditory perception and stimulation of the vestibular organ with patients suffering from tinnitus or a noise-induced hearing loss compared to healthy people. The endpoint measurement is expected the end of june 2019.

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Secondary Outcome

We hypothesize that stimulation of the vestibualr organ has a different effect on the acoustical perception of patients than on healthy people`s acoustical perception, whereas the effect of a somatosensory stimulus is the same in both groups. This hypothesis is to be verfied.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/05/07
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

age: 18 years and older
patients: diagnosed tinnitus or noise-induced hearing loss

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Exclusion Criteria

hardness of hearing without tinnitus, that is no noise-induced hearing loss
ferromagnetic implants
neurological or psychiatric diseases
patients/probands with hypersensitivity in and on the ear
patients/probands with injuries on the eardrum
patients/probands with operations on the ears
patients with tinnitus, that not caused by hardness of hearing

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Addresses

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    • Universitätsklinikum Jena, Klinik für Neurologie, Biomagnetisches Zentrum
    • Mr.  Dr.  Carsten  Klingner 
    • Am Klinikum 1
    • 07747  Jena
    • Germany
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    •   03641/9-325774
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    • Biomagnetisches Zentrum, Neurologische Klinik des Universitätsklinikum Jena
    • Mr.  Dr.  Ralph  Huonker 
    • Am Klinikum 1
    • 07747  Jena
    • Germany
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    • Biomagnetisches Zentrum; Neurologische Klinik des Universitätsklinikum Jena
    • Mr.  Dr.  Ralph  Huonker 
    • Am Klinikum 1
    • 07747  Jena
    • Germany
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Sources of Monetary or Material Support

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    • BGN (Berufsgenossenschaft Nahrungsmittel und Gastgewerbe)
    • Lucas Cranach Platz 2
    • 99097  Erfurt
    • Germany
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    •   0361-4391-4840
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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