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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MicroTransponder Inc.
ClinicalTrials.gov Identifier:
NCT01253616
First received: December 2, 2010
Last updated: February 16, 2017
Last verified: February 2017
  Purpose
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.

Condition Intervention
Severe Tinnitus Device: vagus nerve stimulation (VNS)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Proof-of-Concept Pilot Study Assessing Vagus Nerve Stimulation (VNS) Paired With Tones for Tinnitus

Resource links provided by NLM:


Further study details as provided by MicroTransponder Inc.:

Primary Outcome Measures:
  • Audiometric measurements [ Time Frame: weekly through one month ]

Secondary Outcome Measures:
  • tinnitus questionaires [ Time Frame: weekly through one month ]
  • adverse events [ Time Frame: as they occur ]

Enrollment: 10
Study Start Date: December 2010
Study Completion Date: June 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VNS plus tones Device: vagus nerve stimulation (VNS)
Daily stimulation synchronized with tones at the study assigned dose (amplitude, frequency, on/off cycle and treatment period).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01253616

Locations
Belgium
University Hospital Antwerp
Antwerp, Edegem, Belgium, 2650
Sponsors and Collaborators
MicroTransponder Inc.
  More Information

Publications:
Responsible Party: MicroTransponder Inc.
ClinicalTrials.gov Identifier: NCT01253616     History of Changes
Other Study ID Numbers: MT-T-01
Study First Received: December 2, 2010
Last Updated: February 16, 2017

Additional relevant MeSH terms:
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 18, 2017