The Treatment of Tinnitus With Transcutaneous Non-invasive Vagus Nerve Stimulation
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 5, 2010
CompletedFirst Posted
Study publicly available on registry
August 6, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedApril 30, 2013
April 1, 2013
2.5 years
August 5, 2010
April 29, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
active t-VNS
EXPERIMENTALactive t-VNS
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- cerbomed GmbHlead
Study Sites (1)
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
Related Publications (1)
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.
PMID: 24996510DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Berthold Langguth, MD
University of Regensburg
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2010
First Posted
August 6, 2010
Study Start
January 1, 2010
Primary Completion
July 1, 2012
Study Completion
March 1, 2013
Last Updated
April 30, 2013
Record last verified: 2013-04