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 range18 Years – 75 Years
SexALL
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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
What they're measuring
1
Safety, feasibility and effectiveness of t-VNS® stimulation