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

Not Applicable

Completed

• Conditions: Severe Tinnitus
• Interventions: Device: vagus nerve stimulation (VNS)

• Registration Number: NCT01253616
• Lead Sponsor: MicroTransponder Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-02
• Study First Submitted QC: 2010-12-02
• Study First Posted: 2010-12-03
• Primary Completion: 2012-02
• Study Completion: 2012-06
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-16
• Last Update Posted: 2017-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VNS plus tones	vagus nerve stimulation (VNS)	-

Primary Outcome Measures

Name	Time	Method
Audiometric measurements	weekly through one month

Secondary Outcome Measures

Name	Time	Method
tinnitus questionaires	weekly through one month
adverse events	as they occur

Trial Locations

Locations (1)

University Hospital Antwerp; 🇧🇪 Antwerp, Edegem, Belgium