Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT01253616
NCT01253616CompletedNot Applicable

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

MicroTransponder Inc.1 site in 1 country10 target enrollmentStarted: December 1, 2010Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
10
Locations
1
Primary Endpoint
Audiometric measurements
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

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

Arms & Interventions

VNS plus tones

Experimental

Intervention: vagus nerve stimulation (VNS) (Device)

Outcomes

Primary Outcomes

Audiometric measurements

Time Frame: weekly through one month

Secondary Outcomes

  • tinnitus questionaires(weekly through one month)
  • adverse events(as they occur)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials

Completed
Not Applicable
Non-Invasive Neurostimulation For the Relief of Symptoms Associated With MigraineMigraine
NCT01532830ElectroCore INC30
Completed
Not Applicable
Proof of Concept Study of Vagus Nerve StimulationPrader-Willi SyndromeTranscutaneous Vagal Nerve Stimulation (tVNS)
NCT03689621Jessica Beresford-Webb9
Terminated
Not Applicable
Noninvasive Neurostimulation of the Vagus Nerve for the Relief of Acute Bronchoconstriction Due to AsthmaAsthma
NCT01385306ElectroCore INC6
Completed
Not Applicable
Relief of Acute Bronchoconstriction/Asthma Using the Non-Invasive AlphaCore DeviceAsthma
NCT01532817ElectroCore INC30
Unknown
Not Applicable
Luma Light System Proof of Concept Study in Subjects With Mild to Moderate PsoriasisPsoriasis
NCT02447068Illumicure Inc10