- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01176734
The Treatment of Tinnitus With Transcutaneous Non-invasive Vagus Nerve Stimulation
April 29, 2013 updated by: cerbomed GmbH
The Treatment of Tinnitus With Transcutaneous Non-invasive Vagus Nerve stimulation-a Controlled Randomized Pilot Study Assessing Safety, Compatibility and Clinical Performance
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bavaria
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Regensburg, Bavaria, Germany, 93053
- 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
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: active t-VNS
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Active treatment with the t-VNS device.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety, feasibility and effectiveness of t-VNS® stimulation
Time Frame: 24 weeks
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Determination of safety, feasibility and effectiveness of t-VNS measured by tinnitus score according to Goebel and Hiller between baseline and week 24
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24 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Berthold Langguth, MD, University of Regensburg
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Actual)
July 1, 2012
Study Completion (Actual)
March 1, 2013
Study Registration Dates
First Submitted
August 5, 2010
First Submitted That Met QC Criteria
August 5, 2010
First Posted (Estimate)
August 6, 2010
Study Record Updates
Last Update Posted (Estimate)
April 30, 2013
Last Update Submitted That Met QC Criteria
April 29, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- cMPsTIN01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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