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

Tinnitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01176734
• Other study ID #: cMPsTIN01
• Status: Completed
• Phase: N/A
• First received: August 5, 2010
• Last updated: April 29, 2013
• Start date: January 2010
• Est. completion date: March 2013

Study information

• Verified date: April 2013
• Source: cerbomed GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2013
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tinnitus

Intervention

Device:
• tVNS-Device
Active treatment with the t-VNS device.

Locations

Country	Name	City	State
Germany	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

Sponsors (1)

Lead Sponsor	Collaborator
cerbomed GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24 weeks	Yes