Sub-chronic Neurostimulation Delivered in the Middle Ear for Tinnitus Suppression
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ClinicalTrials.gov Identifier: NCT01549145 |
Recruitment Status
:
Completed
First Posted
: March 9, 2012
Last Update Posted
: August 29, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Tinnitus | Device: Nimbus Multifunctional Stimulator | Not Applicable |
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 |

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)
|
- 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).
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Total score on the Handicap Inventory (THI) of at least 40.
- Visual scale over 5.
- 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.
- Not being physically or geographically capable of returning for scheduled follow-up visits.
- Any physical, psychological, or emotional disorder that would interfere with the planned surgical operations
- Mentally retarded, developmentally delayed or suffering from organic brain dysfunction.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01549145
Israel | |
Shaare Zedek Medical Center | |
Jerusalem, Israel |
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 Key Record Dates |
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 |