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

Not Applicable

Completed

• Conditions: Tinnitus
• Interventions: Device: tVNS-Device

• Registration Number: NCT01176734
• Lead Sponsor: cerbomed GmbH

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 study addressing the treatment of tinnitus with transcutaneous vagus nerve stimulation.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-08-05
• Study First Submitted QC: 2010-08-05
• Study First Posted: 2010-08-06
• Primary Completion: 2012-07
• Study Completion: 2013-03
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-29
• Last Update Posted: 2013-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
active t-VNS	tVNS-Device	active t-VNS

Primary Outcome Measures

Name	Time	Method
Safety, feasibility and effectiveness of t-VNS® stimulation	24 weeks	Determination of safety, feasibility and effectiveness of t-VNS measured by tinnitus score according to Goebel and Hiller between baseline and week 24

Trial Locations

Locations (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