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

MicroTransponder Inc.10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Severe Tinnitus

Interventions

vagus nerve stimulation (VNS)DEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital Antwerp

Antwerp, Edegem, Belgium

Outcomes

Primary Outcomes

Audiometric measurements

Time frame: weekly through one month

Secondary Outcomes

tinnitus questionaires

Time frame: weekly through one month

adverse events

Time frame: as they occur

Data from ClinicalTrials.gov

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