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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
Sponsor:
Information provided by (Responsible Party):
EstimME Ltd.

Study Description
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

Arms and Interventions
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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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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, Older Adult)
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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Information from the National Library of Medicine

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


Locations
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Israel
Shaare Zedek Medical Center
Jerusalem, Israel
Sponsors and Collaborators
EstimME Ltd.
More Information
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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:
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Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
 Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms