Sub-chronic Neurostimulation Delivered in the Middle Ear for Tinnitus Suppression

EstimME Ltd.1 site in 1 country14 target enrollmentJune 2010

ConditionsTinnitus

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Tinnitus
Sponsor: EstimME Ltd.
Enrollment: 14
Locations: 1
Primary Endpoint: Efficacy
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objectives of this study are to evaluate the safety and efficacy of applying electrical stimulation on the promontorium (EPS) for the suppression of tinnitus in a sub-chronic stimulation regimen.

Registry

clinicaltrials.gov

Start Date

June 2010

End Date

April 2011

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

EstimME Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Total score on the Handicap Inventory (THI) of at least
•Visual scale over
•Tinnitus origin is peripheral (related to long term noise exposure, or to a sudden exposure to a very loud noise etc.)
•Tinnitus is on-going; present for more than 50% of the time over the past 12 months.
•Unilateral tinnitus
•Tinnitus prevalent at least 12 months.
•Willingness to abstain from part taking in other, non-study procedures indicated to lessen tinnitus and/or its perception.
•Willing and able to refrain from engaging in activities or work involving loud noise exposure.
•Male or females 18-60 years of age

Exclusion Criteria

•Prior history of sudden hearing loss and/or fluctuating hearing levels.
•Tinnitus prevalent more than 3 years.
•History of frequent middle ear infections
•Patient under immunosuppressant therapy
•Auditory nerve damage.
•Vestibular Schwannoma
•Cochlear implant.
•Pregnant or lactating.
•Developmental disability or cognitive impairment that would make it difficult for the subject to partake in the clinical study, including adequate comprehension of the informed consent form and ability to record the necessary measurements.
•Involvement in litigation and/or a worker's compensation claim and/or receiving disability benefits related to tinnitus and/or hearing loss.

Outcomes

Primary Outcomes

Efficacy

Time Frame: 2 months

Study efficacy evaluations will be based on the analysis of pre and post procedure tinnitus severity characteristics (THI, MML, Pitch matching and VAS values).