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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
EstimME Ltd.
ClinicalTrials.gov Identifier:
NCT01549145
First received: March 6, 2012
Last updated: August 28, 2012
Last verified: August 2012
History of Changes
  Purpose

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 Intervention
Tinnitus
 Device: Nimbus Multifunctional Stimulator

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Tinnitus
U.S. FDA Resources

Further study details as provided by EstimME Ltd.:

Primary Outcome Measures:
  • Efficacy [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    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:
  • Safety [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 14
Study Start Date: June 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01549145

Locations
Israel
Shaare Zedek Medical Center
Jerusalem, Israel
Sponsors and Collaborators
EstimME Ltd.
  More Information

No publications provided

Responsible Party: EstimME Ltd.
ClinicalTrials.gov Identifier: NCT01549145     History of Changes
Obsolete Identifiers: NCT01139554
Other Study ID Numbers: EST-01-IL
Study First Received: March 6, 2012
Last Updated: August 28, 2012
Health Authority: Israel: Ethics Commission

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

ClinicalTrials.gov processed this record on May 23, 2013