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Sub-chronic Neurostimulation Delivered in the Middle Ear for Tinnitus Suppression
This study has been completed.
Sponsor:
EstimME Ltd.
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
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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: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by EstimME Ltd.:
Primary Outcome Measures:
- 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:
- 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.
| 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 (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01549145
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
| 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 |
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 June 23, 2017