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

cerbomed GmbH1 site in 1 country50 target enrollmentJanuary 2010

ConditionsTinnitus

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Tinnitus
Sponsor: cerbomed GmbH
Enrollment: 50
Locations: 1
Primary Endpoint: Safety, feasibility and effectiveness of t-VNS® stimulation
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2010

End Date

March 2013

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

cerbomed GmbH

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

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