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CompletedNCT01253616Updated Feb 17, 2017

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

An interventional study of vagus nerve stimulation (VNS) in Severe Tinnitus, sponsored by MicroTransponder Inc.. Completed at 1 site in Belgium. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-02-17.

Sponsored by MicroTransponder Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Severe Tinnitus

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03

In context

Tinnitus

412 studies on the registry are indexed under Tinnitus; 87 are open to participants now.

This study's enrollment of 10 is below the median of 60 across 339 interventional studies indexed under Tinnitus.

Browse Tinnitus studies →

Lead sponsor

MicroTransponder Inc. is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    VNS plus tones

    Device: vagus nerve stimulation (VNS)

Interventions

  • Devicevagus nerve stimulation (VNS)

    Daily stimulation synchronized with tones at the study assigned dose (amplitude, frequency, on/off cycle and treatment period).

06

What researchers measure

Primary outcomes

  1. Audiometric measurements

    Time frame: weekly through one month

Secondary outcomes

  1. tinnitus questionaires

    Time frame: weekly through one month

  2. adverse events

    Time frame: as they occur

07

Study locations

1 site
  • University Hospital Antwerp
    Antwerp, Edegem 2650, Belgium
08

References and documents

Publications

  • De Ridder D, Vanneste S, Engineer ND, Kilgard MP. Safety and efficacy of vagus nerve stimulation paired with tones for the treatment of tinnitus: a case series. Neuromodulation. 2014 Feb;17(2):170-9. doi: 10.1111/ner.12127. Epub 2013 Nov 20. PubMed 24255953 ↗
  • De Ridder D, Kilgard M, Engineer N, Vanneste S. Placebo-controlled vagus nerve stimulation paired with tones in a patient with refractory tinnitus: a case report. Otol Neurotol. 2015 Apr;36(4):575-80. doi: 10.1097/MAO.0000000000000704. PubMed 25689839 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01253616
Lead sponsor
MicroTransponder Inc.
Responsible party
Sponsor
First posted
Dec 3, 2010
Start date
Dec 2010
Primary completion
Feb 2012
Completion
Jun 2012
Last update
Feb 17, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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