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

MicroTransponder

Status: Completed

Conditions: Severe Tinnitus

Treatments: Device: vagus nerve stimulation (VNS)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01253616

MT-T-01

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

VNS plus tones

Experimental group

Treatment:

Device: vagus nerve stimulation (VNS)