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

NCT ID: NCT01176734

Last Updated: 2013-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2013-03-31

Brief Summary

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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

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Conditions

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Tinnitus

Keywords

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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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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active t-VNS

active t-VNS

Group Type EXPERIMENTAL

tVNS-Device

Intervention Type DEVICE

Active treatment with the t-VNS device.

Interventions

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tVNS-Device

Active treatment with the t-VNS device.

Intervention Type DEVICE

Eligibility Criteria

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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)
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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cerbomed GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Berthold Langguth, MD

Role: PRINCIPAL_INVESTIGATOR

University of Regensburg

Locations

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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, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 24996510 (View on PubMed)

Other Identifiers

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cMPsTIN01

Identifier Type: -

Identifier Source: org_study_id