Sub-chronic Neurostimulation Delivered in the Middle Ear for Tinnitus Suppression
Primary Purpose
Tinnitus
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Nimbus Multifunctional Stimulator
Sponsored by
About this trial
This is an interventional treatment trial for Tinnitus focused on measuring Severe, Ongoing, Unilateral, present for more than 6 months
Eligibility Criteria
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.
Sites / Locations
- Shaare Zedek Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
NIMBUS multifunctional stimulator
Arm Description
A Multifunctional Stimulator (Nimbus by Newmedic, Hemodia) for clinical use. The stimulator is also dedicated for Electrical Promontory Stimulation (EPS)
Outcomes
Primary Outcome Measures
Efficacy
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01549145
Brief Title
Sub-chronic Neurostimulation Delivered in the Middle Ear for Tinnitus Suppression
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EstimME Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus
Keywords
Severe, Ongoing, Unilateral, present for more than 6 months
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NIMBUS multifunctional stimulator
Arm Type
Experimental
Arm Description
A Multifunctional Stimulator (Nimbus by Newmedic, Hemodia) for clinical use. The stimulator is also dedicated for Electrical Promontory Stimulation (EPS)
Intervention Type
Device
Intervention Name(s)
Nimbus Multifunctional Stimulator
Intervention Description
A Multifunctional Stimulator (Nimbus by Newmedic, Hemodia) for clinical use. The stimulator is also dedicated for Electrical Promontory Stimulation (EPS)
Primary Outcome Measure Information:
Title
Efficacy
Description
Study efficacy evaluations will be based on the analysis of pre and post procedure tinnitus severity characteristics (THI, MML, Pitch matching and VAS values).
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Safety
Description
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.
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
Country
Israel
12. IPD Sharing Statement
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Sub-chronic Neurostimulation Delivered in the Middle Ear for Tinnitus Suppression
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