Trial document





This trial has been registered retrospectively.
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  DRKS00012609

Trial Description

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Title

Physiological Regulation of Chronic Tinnitus

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Trial Acronym

NeuroTinn

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

Chronic tinnitus co-varies with a decrease of inhibition of the central auditory system. This project investigates a new rehabilitation strategy using training of local neuronal inhibition in the auditory system with local alpha-EEG-neurofeedback: 3 comparable groups with 20 patients each suffering from chronic tinnitus receive
(1) Neurofeedback of local auditory alpha-rhythm with simultaneous alpha-blockade in the somatosensory and visual projection areas of the brain in order to revive physiological inhibition in the auditory system in the experimental group (EG), (2) receive identical training as the EG but without association (contingency) between auditory cortex alpha and feedback in the control group (CG) and (3) receive cognitive behavior therapy (CBT) of the tinnitus in the third group.
We expect that the EG shows a neurophysiological and behavioral and perceptual stable reduction of tinnitus and that local neuronal inhibition (alpha) and cortical reorganization of the auditory system reflect the behavioral improvement of the rehabilitation training.

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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

  •   DRKS00012609
  •   2017/07/17
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  •   yes
  •   Approved
  •   694/2014B02, Ethik-Kommission an der Medizinischen Fakultät der Eberhard-Karls-Universität und am Universitätsklinikum Tübingen
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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

  •   Experimental group (EC): LBA (local brain activity) - Neurofeedback, 10 sessions, 2-3 times a week; 2 subgroups (1 subgroup starts immediately with the training / 2nd subgroup starts when the first subgroup has finished its sessions) - blinded
  •   Control group 1: identical process as Arm1 with placebo neurofeedback; 2 subgroups (1 subgroup starts immediately with the training / 2nd subgroup starts when the first subgroup has finished its sessions) - blinded
  •   Cognitive Behavioral Therapy (CBT), 10 sessions; 2 subgroups (1 subgroup starts immediately with the training / 2nd subgroup starts when the 1st subgroup has finished its sessions)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Placebo, Active control (effective treament of control group), Control group receives no treatment
  •   Treatment
  •   Other
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Primary Outcome

Primarily the focus is on changes of A1-EEG- alpha and delta power, and
tinnitus intensity (TIM) in the EG and CG as well as changes of tinnitus intensity (TIM), loudness
(VAS) and distress (VAS) by use of questionnaires in the EG, CG and CBT-group. The measurements are made in each session or daily, before treatment, at an interim time, after treatment and in follow-up; a total of at least 14 measurements are taken


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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/04/27
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

unilateral, persistent and stable tinnitus for >11 weeks,
normal findings using an ear microscope,
normal tympanic membrane mobility and stapedial reflex,
ability to fill out relevant questionnaires,
gap between the sound pressure level in the audiometric tinnitus matching (tinnitus level above
threshold) and the tinnitus loudness (Zenner and de Maddalena, 2005).

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Exclusion Criteria

pulsatile, intermittent, or non-persistent tinnitus,
bilateral tinnitus,
tinnitus as a concomitant symptom of a known systemic disease (such as vestibular schwannoma, endolymphatic hydrops, or Menière’s disease),
known retrocochlear hearing defect (such as those detected through brainstem evoked response audiometry),
conductive hearing loss exceeding 10 dB at two or more frequencies,
ear canal or middle ear inflammation or effusion,
one or two sided total deafness,
status following a craniocerebral trauma,
cervicogenic or stomatognatogenic tinnitus,
start of therapy with maskers 2 months preceding therapy,
start of autogenic training or psychotherapy <4 weeks before therapy,
ongoing acupuncture therapy,
drug treatment for tinnitus within 24 h preceding therapy,
inability to discontinue drugs known to be associated with tinnitus (high-dose aspirin, quinidine,
aminoglycosides) or psychotropic medication prior to entry into the study,
epilepsy,
age > 60,
Parkinson’s disease,
dementia,
acute allergic disease,
neurological or psychiatric disease,
drug or alcohol abuse that would interfere with regular completion of the study,
consuming diseases,
history of a severe ischemic disorder (previous stroke, previous heart attack, peripheral arterial
occlusion disease),
exposure to an investigational agent within the previous 4 weeks,
anticipated non-availability for study visits or procedures,
insufficient command of German.

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Addresses

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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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