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: August 14, 2012
Last verified: August 2012
  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 Phase
Severe Tinnitus
Device: vagus nerve stimulation (VNS)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • tinnitus questionaires [ Time Frame: weekly through one month ] [ Designated as safety issue: No ]
  • adverse events [ Time Frame: as they occur ] [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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

No publications provided

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: August 14, 2012
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

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 September 30, 2014