CompletedNCT01176734Updated Apr 30, 2013

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

An interventional study of tVNS-Device in Tinnitus, sponsored by cerbomed GmbH. Completed at 1 site in Germany. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2013-04-30.

Sponsored by cerbomed GmbH · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 50
Allocation: Non-randomized
Ages: 18 Years to 75 Years
Sex: All

Study 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.

Conditions studied

Tinnitus

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Tinnitus 412

Keywords

Pulsatile Tinnitus
Ringing-Buzzing-Tinnitus
Spontaneous Oto-Acoustic Emission Tinnitus
Tensor Palatini Induced Tinnitus
Tensor Tympani Induced Tinnitus
Tinnitus of Vascular Origin
Tinnitus, Clicking
Tinnitus, Leudet
Tinnitus, Leudet's
Tinnitus, Noise Induced
Tinnitus, Objective
Tinnitus, Spontaneous Oto-Acoustic Emission
Tinnitus, Subjective
Tinnitus, Tensor Palatini Induced
Tinnitus, Tensor Tympani Induced
Vascular Origin Tinnitus

In context

Tinnitus

412 studies on the registry are indexed under Tinnitus; 87 are open to participants now.

This study's enrollment of 50 is below the median of 60 across 339 interventional studies indexed under Tinnitus.

Browse Tinnitus studies →

Lead sponsor

cerbomed GmbH is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Phase: Not applicable
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Single group
Masking: None (open label)
Enrollment: 50 participants (actual)

Study arms

Experimental
active t-VNS
active t-VNS
Device: tVNS-Device

Interventions

DevicetVNS-Device
Active treatment with the t-VNS device.

What researchers measure

Primary outcomes

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

Study locations

1 site

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 93053, Germany

References and documents

Publications

Kreuzer PM, Landgrebe M, Resch M, Husser O, Schecklmann M, Geisreiter F, Poeppl TB, Prasser SJ, Hajak G, Rupprecht R, Langguth B. Feasibility, safety and efficacy of transcutaneous vagus nerve stimulation in chronic tinnitus: an open pilot study. Brain Stimul. 2014 Sep-Oct;7(5):740-7. doi: 10.1016/j.brs.2014.05.003. Epub 2014 Jun 4. PubMed 24996510 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 30, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01176734
Lead sponsor: cerbomed GmbH
Responsible party: Sponsor
First posted: Aug 6, 2010
Start date: Jan 2010
Primary completion: Jul 2012
Completion: Mar 2013
Last update: Apr 30, 2013

Study contacts

Berthold Langguth, MD

principal investigator · University of Regensburg

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.

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