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

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.

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Key information

Conditions

Tinnitus Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinik für Psychiatrie und Psychotherapie Bezirksklinikum Regensburg Universitätsstr. 84 93053 Regensburg E-mail: [email protected] Tel.: 0941 941 2099 Fax.: 0941 941 2025 Dr. med Michael Landgrebe, Klinik für Psychiatrie und Psychotherapie Bezir

Regensburg, Bavaria, 93053, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tVNS-Device

Device

Active treatment with the t-VNS device.

Primary outcomes

Safety, feasibility and effectiveness of t-VNS® stimulation

Time frame: 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

Sponsors and collaborators

Lead sponsor

cerbomed GmbH

Industry

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2013
First posted: Aug 6, 2010
Registry last updated: Apr 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed