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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2012-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Severe Tinnitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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VNS plus tones

Group Type EXPERIMENTAL

vagus nerve stimulation (VNS)

Intervention Type DEVICE

Daily stimulation synchronized with tones at the study assigned dose (amplitude, frequency, on/off cycle and treatment period).

Interventions

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vagus nerve stimulation (VNS)

Daily stimulation synchronized with tones at the study assigned dose (amplitude, frequency, on/off cycle and treatment period).

Intervention Type DEVICE

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No