Proof-of-Concept Study Assessing VNS Paired With Tones for Tinnitus
NCT01253616 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2017-02-17
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.
Conditions
- Severe Tinnitus
Interventions
- DEVICE
-
vagus nerve stimulation (VNS)
Daily stimulation synchronized with tones at the study assigned dose (amplitude, frequency, on/off cycle and treatment period).
Sponsors & Collaborators
-
MicroTransponder Inc.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-12-31
- Primary Completion
- 2012-02-29
- Completion
- 2012-06-30
Countries
- Belgium
Study Locations
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