The Treatment of Tinnitus With Transcutaneous Non-invasive Vagus Nerve Stimulation

Study Overview
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Brief Summary
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The t-VNS STv3 device is a non-invasive, transcutaneous neurostimulator for influencing the afferent branches of the nervus vagus around the human ear. The clinical trial is designed as a a pilot study addressing the treatment of tinnitus with transcutaneous vagus nerve stimulation.

Official Title
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The Treatment of Tinnitus With Transcutaneous Non-invasive Vagus Nerve stimulation-a Controlled Randomized Pilot Study Assessing Safety, Compatibility and Clinical Performance

Conditions
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Tinnitus

Intervention / Treatment
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* Device: tVNS-Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic tinnitus defined as a tinnitus over more than six months ≥31 points in the tinnitus questionnaire according to Goebel and Hiller Written informed consent Both gender, aged from 18 -75 years If the subject takes psychoactive medication (e.g antidepressants, anticonvulsives) therapy must be stable for at least 10 days. If a treatment with neuroleptics is necessary, only olanzapine and quetiapine should be used. The therapy should be constantly though a necessary change in medication is no reason for exclusion of the subject. Exclusion Criteria: Objective tinnitus Participating in other tinnitus treatments within 3 months before study start Missing informed consent Pregnancy Bronchial asthma in medical history Clinically relevant internistic, neurological or psychiatric diseases Abuse of drugs or alcohol until 12 weeks before enrollment in the study Indications of structural impairment of the basal ganglia or the brain stem Active implants (e.g. cochlea implants, VNS, pacemaker) Constant all-day use of hearing instruments or noisers on the left the part-time use in special situations (e.g. watching TV is no exclusion criteria All dermatologic and infectious diseases which affect the area around the pinna and the ear canal Severe malformation of the pinna Other circumstances that in the opinion of the investigator might be an obstacle for enrolling the subject

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: active t-VNS<br>active t-VNS | Device: tVNS-Device<br>* Active treatment with the t-VNS device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety, feasibility and effectiveness of t-VNS® stimulation | Determination of safety, feasibility and effectiveness of t-VNS measured by tinnitus score according to Goebel and Hiller between baseline and week 24 | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulsatile Tinnitus, Ringing-Buzzing-Tinnitus, Spontaneous Oto-Acoustic Emission Tinnitus, Tensor Palatini Induced Tinnitus, Tensor Tympani Induced Tinnitus, Tinnitus of Vascular Origin, Tinnitus, Clicking, Tinnitus, Leudet, Tinnitus, Leudet's, Tinnitus, Noise Induced, Tinnitus, Objective, Tinnitus, Spontaneous Oto-Acoustic Emission, Tinnitus, Subjective, Tinnitus, Tensor Palatini Induced, Tinnitus, Tensor Tympani Induced, Vascular Origin Tinnitus