We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Proof-of-Concept Study Assessing VNS Paired With Tones for Tinnitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01253616
Recruitment Status : Completed
First Posted : December 3, 2010
Last Update Posted : February 17, 2017
Information provided by (Responsible Party):
MicroTransponder Inc.

Brief Summary:
This is a proof-of-concept study designed to provide feasibility information on the clinical use of vagus nerve stimulation (VNS) paired with tones for the treatment of severe tinnitus. The study is expected to give preliminary efficacy and safety information.

Condition or disease Intervention/treatment
Severe Tinnitus Device: vagus nerve stimulation (VNS)

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Proof-of-Concept Pilot Study Assessing Vagus Nerve Stimulation (VNS) Paired With Tones for Tinnitus
Study Start Date : December 2010
Primary Completion Date : February 2012
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus
U.S. FDA Resources

Arm Intervention/treatment
Experimental: VNS plus tones Device: vagus nerve stimulation (VNS)
Daily stimulation synchronized with tones at the study assigned dose (amplitude, frequency, on/off cycle and treatment period).

Primary Outcome Measures :
  1. Audiometric measurements [ Time Frame: weekly through one month ]

Secondary Outcome Measures :
  1. tinnitus questionaires [ Time Frame: weekly through one month ]
  2. adverse events [ Time Frame: as they occur ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Key Inclusion Criteria:

  • 18 to 65 years of age
  • Diagnosed with subjective tinnitus due to hearing loss with at least some tonal quality of the tinnitus.
  • Diagnosis of tinnitus for at least one year
  • Tinnitus severity of 18 or greater on TRQ cross checked with TQ severity of Grade 3 or worse

Key Exclusion Criteria:

  • Acute or intermittent tinnitus
  • Severe hearing loss
  • History of significant ear disease such as Meniere's disease, ear tumors, or evidence of active middle ear disease.
  • Any other implanted device

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01253616

University Hospital Antwerp
Antwerp, Edegem, Belgium, 2650
Sponsors and Collaborators
MicroTransponder Inc.

Responsible Party: MicroTransponder Inc.
ClinicalTrials.gov Identifier: NCT01253616     History of Changes
Other Study ID Numbers: MT-T-01
First Posted: December 3, 2010    Key Record Dates
Last Update Posted: February 17, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms