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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Tinnitus	Device: Nimbus Multifunctional Stimulator	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	14 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Study Start Date :	June 2010
Actual Primary Completion Date :	April 2011
Actual Study Completion Date :	April 2011

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: NIMBUS multifunctional stimulator; A Multifunctional Stimulator (Nimbus by Newmedic, Hemodia) for clinical use. The stimulator is also dedicated for Electrical Promontory Stimulation (EPS)	Device: Nimbus Multifunctional Stimulator; A Multifunctional Stimulator (Nimbus by Newmedic, Hemodia) for clinical use. The stimulator is also dedicated for Electrical Promontory Stimulation (EPS)

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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).

Secondary Outcome Measures :

1. Safety [ Time Frame: 2 months ]
   Safety evaluations will be based on the observation for the reporting of any adverse events occurring during the study and up to the 30 days follow-up visit Occurrence of adverse events.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

1. Total score on the Handicap Inventory (THI) of at least 40.
2. Visual scale over 5.
3. Tinnitus origin is peripheral (related to long term noise exposure, or to a sudden exposure to a very loud noise etc.)
4. Tinnitus is on-going; present for more than 50% of the time over the past 12 months.
5. Unilateral tinnitus
6. Tinnitus prevalent at least 12 months.
7. Willingness to abstain from part taking in other, non-study procedures indicated to lessen tinnitus and/or its perception.
8. Willing and able to refrain from engaging in activities or work involving loud noise exposure.
9. Male or females 18-60 years of age

Exclusion Criteria:

1. Prior history of sudden hearing loss and/or fluctuating hearing levels.
2. Tinnitus prevalent more than 3 years.
3. History of frequent middle ear infections
4. Patient under immunosuppressant therapy
5. Auditory nerve damage.
6. Vestibular Schwannoma
7. Cochlear implant.
8. Pregnant or lactating.
9. 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.
10. Involvement in litigation and/or a worker's compensation claim and/or receiving disability benefits related to tinnitus and/or hearing loss.
11. Not being physically or geographically capable of returning for scheduled follow-up visits.
12. Any physical, psychological, or emotional disorder that would interfere with the planned surgical operations
13. Mentally retarded, developmentally delayed or suffering from organic brain dysfunction.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Israel
Shaare Zedek Medical Center
Jerusalem, Israel

Sponsors and Collaborators

EstimME Ltd.

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	EstimME Ltd.
ClinicalTrials.gov Identifier:	NCT01549145 History of Changes
Obsolete Identifiers:	NCT01139554
Other Study ID Numbers:	EST-01-IL
First Posted:	March 9, 2012
Last Update Posted:	August 29, 2012
Last Verified:	August 2012

Keywords provided by EstimME Ltd.:

Severe; Ongoing; Unilateral; present for more than 6 months

Additional relevant MeSH terms:

Tinnitus; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases	Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms