Status:
COMPLETED
Proof-of-Concept Study Assessing VNS Paired With Tones for Tinnitus
Lead Sponsor:
MicroTransponder Inc.
Conditions:
Severe Tinnitus
Eligibility:
All Genders
18-65 years
Phase:
NA
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 e...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01253616
Start Date
December 1 2010
End Date
June 1 2012
Last Update
February 17 2017
Active Locations (1)
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1
University Hospital Antwerp
Antwerp, Edegem, Belgium, 2650