Proof-of-Concept Study Assessing VNS Paired With Tones for Tinnitus
A Proof-of-Concept Pilot Study Assessing Vagus Nerve Stimulation (VNS) Paired With Tones for Tinnitus
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 2, 2010
CompletedFirst Posted
Study publicly available on registry
December 3, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedFebruary 17, 2017
February 1, 2017
1.2 years
December 2, 2010
February 16, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Audiometric measurements
weekly through one month
Secondary Outcomes (2)
tinnitus questionaires
weekly through one month
adverse events
as they occur
Study Arms (1)
VNS plus tones
EXPERIMENTALInterventions
Daily stimulation synchronized with tones at the study assigned dose (amplitude, frequency, on/off cycle and treatment period).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Antwerp
Antwerp, Edegem, 2650, Belgium
Related Publications (2)
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.
PMID: 24255953RESULTDe 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.
PMID: 25689839RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2010
First Posted
December 3, 2010
Study Start
December 1, 2010
Primary Completion
February 1, 2012
Study Completion
June 1, 2012
Last Updated
February 17, 2017
Record last verified: 2017-02