H93.1
Conditions
Interventions
Group 1: 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
Group 2: Control group 1: identical process as Arm1 with
2 subgroups (1 subgroup starts immediately with the training / 2nd subgroup starts when the first subgroup has finished its sessions) - blinded
Group 3: 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)
Sponsors
Institute of Medical Psychology and Behavioural Neurobiology
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
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).
Exclusion criteria
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Germany
Contacts
Public ContactAzim Malekshahi
Institut für Medizinische Psychologie und VerhaltensneurobiologieUniversität Tübingen
Outcome results
None listed