Status:
COMPLETED
The Treatment of Tinnitus With Transcutaneous Non-invasive Vagus Nerve Stimulation
Lead Sponsor:
cerbomed GmbH
Conditions:
Tinnitus
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 stud...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01176734
Start Date
January 1 2010
End Date
March 1 2013
Last Update
April 30 2013
Active Locations (1)
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1
Klinik für Psychiatrie und Psychotherapie Bezirksklinikum Regensburg Universitätsstr. 84 93053 Regensburg E-mail: Berthold.Langguth@medbo.de Tel.: 0941 941 2099 Fax.: 0941 941 2025 Dr. med Michael Landgrebe, Klinik für Psychiatrie und Psychotherapie Bezir
Regensburg, Bavaria, Germany, 93053