The Treatment of Tinnitus With Transcutaneous Non-invasive Vagus Nerve Stimulation (NCT01176734) | Clinical Trial Compass
CompletedNot Applicable
The Treatment of Tinnitus With Transcutaneous Non-invasive Vagus Nerve Stimulation
Germany50 participantsStarted 2010-01
Plain-language summary
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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety, feasibility and effectiveness of t-VNS® stimulation