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

February 16, 2017 updated by: MicroTransponder Inc.

A Proof-of-Concept Pilot Study Assessing Vagus Nerve Stimulation (VNS) Paired With Tones for Tinnitus

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Edegem
      • Antwerp, Edegem, Belgium, 2650
        • University Hospital Antwerp

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Audiometric measurements
Time Frame: weekly through one month
weekly through one month

Secondary Outcome Measures

Outcome Measure
Time Frame
tinnitus questionaires
Time Frame: weekly through one month
weekly through one month
adverse events
Time Frame: as they occur
as they occur

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MicroTransponder Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

December 2, 2010

First Submitted That Met QC Criteria

December 2, 2010

First Posted (Estimate)

December 3, 2010

Study Record Updates

Last Update Posted (Actual)

February 17, 2017

Last Update Submitted That Met QC Criteria

February 16, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MT-T-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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