Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
cerbomed GmbH
ClinicalTrials.gov Identifier:
NCT01176734
First received: August 5, 2010
Last updated: April 29, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention
Tinnitus
 Device: tVNS-Device

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Treatment of Tinnitus With Transcutaneous Non-invasive Vagus Nerve stimulation-a Controlled Randomized Pilot Study Assessing Safety, Compatibility and Clinical Performance

Resource links provided by NLM:

MedlinePlus related topics: Tinnitus
U.S. FDA Resources

Further study details as provided by cerbomed GmbH:

Primary Outcome Measures:
  • Safety, feasibility and effectiveness of t-VNS® stimulation [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    Determination of safety, feasibility and effectiveness of t-VNS measured by tinnitus score according to Goebel and Hiller between baseline and week 24


Enrollment: 50
Study Start Date: January 2010
Study Completion Date: March 2013
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: active t-VNS
active t-VNS
 Device: tVNS-Device
Active treatment with the t-VNS device.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01176734

Locations
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, Germany, 93053
Sponsors and Collaborators
cerbomed GmbH
Investigators
Principal Investigator: Berthold Langguth, MD University of Regensburg
  More Information

No publications provided

Responsible Party: cerbomed GmbH
ClinicalTrials.gov Identifier: NCT01176734     History of Changes
Other Study ID Numbers: cMPsTIN01
Study First Received: August 5, 2010
Last Updated: April 29, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by cerbomed GmbH:
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:
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
 Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013