Efficacy Study for Development and Use of Neurofeedback-trainings for Patients Suffering From Chronic Tinnitus

Study Overview
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Brief Summary
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Chronic tinnitus affects about 10-15% of the population in industrialized countries. Investigations of the brain activity by using electroencephalography (EEG) showed that in localized regions of the hearing system brain activity was decreased. This reduction of activity is thought to be one of the reasons that keep the perception of the tinnitus going. Recent studies have shown that neurofeedback is a viable option for treatment of chronic tinnitus. By using neurofeedback it is possible to train brain functions by the simple principle of rewarding wanted changes and punishing unwanted ones. The purpose of the investigators study is to show the efficacy of specific localized neurofeedback training in comparison to global relaxing neurofeedback training. In order to achieve decreased tinnitus symptoms or even disappearance of the tinnitus, 15 neurofeedback trainings are planned. Before and up to 6 month after the training EEG-recordings are performed.

Official Title
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A Monocentric Study for Development and Use of Tomographic Neurofeedback Protocols for Patients Suffering From Chronic Tinnitus

Conditions
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Tinnitus, Subjective

Intervention / Treatment
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* Device: Tomographic Neurofeedback
* Device: Non Tomographic Neurofeedback


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-75 Chronic Tinnitus > 0.5 years Informed Consent Fluent in German language Exclusion Criteria: Psychological and neurological disorders other than tinnitus Drug- or Alcohol abuse Tranquilizer, antiepileptic drugs, antipsychotics or anesthetics intake Impairing hearing loss or Cochlea Implant

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tomographic Neurofeedback (TONF)<br>15x Neurofeedback Trainings, 1-2 times per week | Device: Tomographic Neurofeedback<br>* EEG-Electrodes are placed on the patients head to record the brain activity, EEG-recordings are processed by the standardized Low Resolution Brain Electromagnetic Tomography algorithm (sLORETA) to calculate the frequency spectrum in the auditory cortex and deliver feedback for the patient<br>|
| Active Comparator: Non Tomographic Neurofeedback (NTE)<br>15x Neurofeedback Trainings, 1-2 times per week | Device: Non Tomographic Neurofeedback<br>* EEG-electrodes are placed on the patients head, but only 4 electrodes (Fc1, Fc2, F3 and F4 of a 10-10 EEG-system) record the surface activity and generate the feedback for the patient.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Tinnitus symptoms assessed by questionnaires | Assessement of the Tinnitus symptoms before and after the Treatment with neurofeedback by different questionnaires tailored for Tinnitus and Quality of life. | at 1, 3, 6 month follow up | 
| Change from Baseline in delta (3-4Hz) and alpha (8-12Hz) frequency band EEG-activity in the auditory cortex | EEG recordings of the trained frequency bands are compared before and after the Intervention in the named time periods | at 1, 3, 6 month follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in efficacy between Tomographic Neurofeedback (TONF) and Non Tomographic Neurofeedback (NTE) in treatment of tinnitus assessed by tinnitus questionnaires and frequency band EEG-activity measurements (3-4Hz and 8-12Hz) compared to Baseline. | Investigation if there is a significant benefit in the TONF Group, compared to the non tomographic Group. | at 1, 3, 6 month follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adult, Aged, Alpha Rhythm, Auditory Cortex, Chronic, Electroencephalography, Female, Humans, Male, Neurofeedback, Prospective Studies, Questionnaires, Tinnitus, Treatment Outcome