Proof-of-Concept Study Assessing VNS Paired With Tones for Tinnitus
Primary Purpose
Severe Tinnitus
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
vagus nerve stimulation (VNS)
Sponsored by
About this trial
This is an interventional treatment trial for Severe Tinnitus
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
Sites / Locations
- University Hospital Antwerp
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
VNS plus tones
Arm Description
Outcomes
Primary Outcome Measures
Audiometric measurements
Secondary Outcome Measures
tinnitus questionaires
adverse events
Full Information
NCT ID
NCT01253616
First Posted
December 2, 2010
Last Updated
February 16, 2017
Sponsor
MicroTransponder Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01253616
Brief Title
Proof-of-Concept Study Assessing VNS Paired With Tones for Tinnitus
Official Title
A Proof-of-Concept Pilot Study Assessing Vagus Nerve Stimulation (VNS) Paired With Tones for Tinnitus
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MicroTransponder Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Tinnitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VNS plus tones
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
vagus nerve stimulation (VNS)
Intervention Description
Daily stimulation synchronized with tones at the study assigned dose (amplitude, frequency, on/off cycle and treatment period).
Primary Outcome Measure Information:
Title
Audiometric measurements
Time Frame
weekly through one month
Secondary Outcome Measure Information:
Title
tinnitus questionaires
Time Frame
weekly through one month
Title
adverse events
Time Frame
as they occur
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
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
Facility Information:
Facility Name
University Hospital Antwerp
City
Antwerp
State/Province
Edegem
ZIP/Postal Code
2650
Country
Belgium
12. IPD Sharing Statement
Citations:
PubMed Identifier
24255953
Citation
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.
Results Reference
result
PubMed Identifier
25689839
Citation
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.
Results Reference
result
Learn more about this trial
Proof-of-Concept Study Assessing VNS Paired With Tones for Tinnitus
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