Clinical Investigation on the Acoustic Stimulation in the Treatment of Chronic Tinnitus

Study Overview
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Brief Summary
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There are many treatments for chronic tinnitus that have been claimed, with varying degrees of statistical reliability. None of those treatments can eradicate the tinnitus completely. Some therapies can reduce the tinnitus symptoms (loudness, annoyance) up to 30%. Thus there is still a need of new treatments that can reduce considerably the tinnitus symptoms and improve the QOL of subjects. Trial objectives: The aim of this trial is the improvement of the QOL (quality of live) by reducing the Tinnitus- Symptoms of the patient. To confirm the efficacy and safety of the coordinated reset technology. These objectives will be assessed: By subjective and objective measurements of the Tinnitus symptoms, loudness and annoyance.

Official Title
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l Prospective Clinical Investigation on the Acoustic Stimulation With the Coordinated Reset of Neural Subpopulations in the Treatment of Chronic Tinnitus

Conditions
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Chronic Tonal Tinnitus

Intervention / Treatment
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* Device: Acoustic CR-Stimulator ANM//Technology: Acoustic coordinated reset


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mentally healthy people Chronic tonal Tinnitus Older than 18 years Signature of the patient informed consent No participation in other tinnitus therapy during the clinical investigation Exclusion Criteria: A necessity for hearing aid Auditory hallucination Symptomatic hearing disorders Morbus Meniere, Tinnitus due to temporomandibular joint disorders Subjects who can't perceive therapeutic tones Brainstem diseases Psychiatric disorders Objective Tinnitus Insufficient treatment of general disorders, anemia, tumor, dialysis, hypertonus ect.

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Active Comparator: Group 1 : G_1<br>G_1: stimulation for 4 - 6 hours a day, 4 tones per sequence | Device: Acoustic CR-Stimulator ANM//Technology: Acoustic coordinated reset<br>* The CR-stimulation was originally developed by Prof. Dr. Dr. Peter Tass for deep brain stimulation (DBS). The CR-stimulation through high frequency short pulses causes a neuronal reorganization in the stimulated brain area establishing a normal neuronal activity. Based on intensive modeling studies, experimental proof of concept (POC) animal studies and a clinical POC, we proved that the pathologic activity can be recuperated to a desynchronized/healthy state with the acoustic CR-stimulation. The acoustic CR-stimulation signal will be generated by the ANM CR-Stimulator and transmitted to the ears through a speaker system<br>|
| Active Comparator: Group 2 :G_2<br>G_2: stimulation for 4 - 6 hours a day with 12-tone sequences | Device: Acoustic CR-Stimulator ANM//Technology: Acoustic coordinated reset<br>* The CR-stimulation was originally developed by Prof. Dr. Dr. Peter Tass for deep brain stimulation (DBS). The CR-stimulation through high frequency short pulses causes a neuronal reorganization in the stimulated brain area establishing a normal neuronal activity. Based on intensive modeling studies, experimental proof of concept (POC) animal studies and a clinical POC, we proved that the pathologic activity can be recuperated to a desynchronized/healthy state with the acoustic CR-stimulation. The acoustic CR-stimulation signal will be generated by the ANM CR-Stimulator and transmitted to the ears through a speaker system<br>|
| Active Comparator: Group3 : G_3<br>G_3: stimulation for 4 - 6 hours a day, 4 tones per sequence with a signal controlled by EEG measurement | Device: Acoustic CR-Stimulator ANM//Technology: Acoustic coordinated reset<br>* The CR-stimulation was originally developed by Prof. Dr. Dr. Peter Tass for deep brain stimulation (DBS). The CR-stimulation through high frequency short pulses causes a neuronal reorganization in the stimulated brain area establishing a normal neuronal activity. Based on intensive modeling studies, experimental proof of concept (POC) animal studies and a clinical POC, we proved that the pathologic activity can be recuperated to a desynchronized/healthy state with the acoustic CR-stimulation. The acoustic CR-stimulation signal will be generated by the ANM CR-Stimulator and transmitted to the ears through a speaker system<br>|
| Active Comparator: Group 4 : G_4<br>G_4: stimulation for 1 hour a day, 4 tones per sequence | Device: Acoustic CR-Stimulator ANM//Technology: Acoustic coordinated reset<br>* The CR-stimulation was originally developed by Prof. Dr. Dr. Peter Tass for deep brain stimulation (DBS). The CR-stimulation through high frequency short pulses causes a neuronal reorganization in the stimulated brain area establishing a normal neuronal activity. Based on intensive modeling studies, experimental proof of concept (POC) animal studies and a clinical POC, we proved that the pathologic activity can be recuperated to a desynchronized/healthy state with the acoustic CR-stimulation. The acoustic CR-stimulation signal will be generated by the ANM CR-Stimulator and transmitted to the ears through a speaker system<br>|
| Placebo Comparator: Group5 : G_5<br>G_5: stimulation with placebo-tone | Device: Acoustic CR-Stimulator ANM//Technology: Acoustic coordinated reset<br>* The CR-stimulation was originally developed by Prof. Dr. Dr. Peter Tass for deep brain stimulation (DBS). The CR-stimulation through high frequency short pulses causes a neuronal reorganization in the stimulated brain area establishing a normal neuronal activity. Based on intensive modeling studies, experimental proof of concept (POC) animal studies and a clinical POC, we proved that the pathologic activity can be recuperated to a desynchronized/healthy state with the acoustic CR-stimulation. The acoustic CR-stimulation signal will be generated by the ANM CR-Stimulator and transmitted to the ears through a speaker system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |