CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
VNS Treatment +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01962558
NCT01962558N/ACompleted

A Blinded Randomized Pilot Study Assessing Vagus Nerve Stimulation (VNS) Paired With Tones for Tinnitus vs. VNS With Unpaired Tones

MicroTransponder Inc.·interventional·Posted Oct 14, 2013·Updated Apr 6, 2018

In Brief

A clinical study evaluating VNS Treatment and VNS Control for Tinnitus. Completed, enrolled 30 participants across 3 sites.

Detailed Summary

Assess the safety and efficacy of VNS paired with tones for tinnitus using a randomized, controlled, parallel study design.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTinnitus
CountriesUnited States

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 14, 2013
Enrollment StartFeb 1, 2014
Primary CompletionMay 1, 2015
Study CompletionMay 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 12.7 years ago

Interventions

VNS Treatmentdevice

VNS is given in brief bursts over a 2.5 hour period. The subject also has headphone connected to a computer, and hears audio tones through the headphones that occur during VNS.

VNS Controldevice

This is the sham-control group; subjects in this group will receive both tones and VNS, but in a manner that is expected to be ineffective.