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Completed

NCT Number: NCT01253616

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

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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Key information

Conditions

Severe Tinnitus Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Tinnitus

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Antwerp

Antwerp, Edegem, 2650, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vagus Nerve Stimulation (VNS)

Device

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

Primary outcomes

  1. Audiometric measurements

    Time frame: weekly through one month

Secondary outcomes

  1. tinnitus questionaires

    Time frame: weekly through one month

  2. adverse events

    Time frame: as they occur

Sponsors and collaborators

Lead sponsor

MicroTransponder Inc.

Industry

Registry information

Official study title

A Proof-of-Concept Pilot Study Assessing Vagus Nerve Stimulation (VNS) Paired With Tones for Tinnitus

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Dec 3, 2010
Registry last updated
Feb 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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