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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014