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

Primary Purpose

Tinnitus

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
tVNS-Device
Sponsored by
cerbomed GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus focused on measuring 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

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

active t-VNS

Arm Description

active t-VNS

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 5, 2010
Last Updated
April 29, 2013
Sponsor
cerbomed GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT01176734
Brief Title
The Treatment of Tinnitus With Transcutaneous Non-invasive Vagus Nerve Stimulation
Official Title
The Treatment of Tinnitus With Transcutaneous Non-invasive Vagus Nerve stimulation-a Controlled Randomized Pilot Study Assessing Safety, Compatibility and Clinical Performance
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
cerbomed GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
active t-VNS
Arm Type
Experimental
Arm Description
active t-VNS
Intervention Type
Device
Intervention Name(s)
tVNS-Device
Intervention Description
Active treatment with the t-VNS device.
Primary Outcome Measure Information:
Title
Safety, feasibility and effectiveness of t-VNS® stimulation
Description
Determination of safety, feasibility and effectiveness of t-VNS measured by tinnitus score according to Goebel and Hiller between baseline and week 24
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Berthold Langguth, MD
Organizational Affiliation
University of Regensburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
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
City
Regensburg
State/Province
Bavaria
ZIP/Postal Code
93053
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
24996510
Citation
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.
Results Reference
derived

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

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