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

Tinnitus Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01549145
• Other study ID #: EST-01-IL
• Status: Completed
• Phase: N/A
• First received: March 6, 2012
• Last updated: August 28, 2012
• Start date: June 2010
• Est. completion date: April 2011

Study information

• Verified date: August 2012
• Source: EstimME Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT01139554

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Tinnitus

Intervention

Device:
• Nimbus Multifunctional Stimulator
A Multifunctional Stimulator (Nimbus by Newmedic, Hemodia) for clinical use. The stimulator is also dedicated for Electrical Promontory Stimulation (EPS)

Locations

Country	Name	City	State
Israel	Shaare Zedek Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
EstimME Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	2 months	No
Secondary	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.	2 months	Yes