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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
EstimME Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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

First Posted
March 6, 2012
Last Updated
August 28, 2012
Sponsor
EstimME Ltd.
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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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