TinnitusNCT01549145
Sub-chronic Neurostimulation Delivered in the Middle Ear for Tinnitus Suppression
A study testing Nimbus Multifunctional Stimulator in people with Tinnitus, run by EstimME Ltd. at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinnitus
- What is being tested?
- Nimbus Multifunctional Stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2010to Apr 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Tinnitus
- Being tested
- Nimbus Multifunctional Stimulator
- Keywords
- Severe, Ongoing, Unilateral, present for more than 6 months
- Medical subject headings
- Tinnitus, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nimbus Multifunctional StimulatorDevice
A Multifunctional Stimulator (Nimbus by Newmedic, Hemodia) for clinical use. The stimulator is also dedicated for Electrical Promontory Stimulation (EPS)
| Study group | Role | What they receive |
|---|---|---|
| NIMBUS multifunctional stimulator | Experimental | A Multifunctional Stimulator (Nimbus by Newmedic, Hemodia) for clinical use. The stimulator is also dedicated for Electrical Promontory Stimulation (EPS) Receives: Device: Nimbus Multifunctional Stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 months
Secondary outcomes (1)
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2012 (estimated)
- Study startJun 2010
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- EstimME Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01549145
- Sponsor's protocol ID
- EST-01-IL
- Status last verified
- Aug 2012
- First submitted
- 6 Mar 2012
- Last updated
- 29 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sub-chronic Neurostimulation Delivered in the Middle Ear for Tinnitus Suppression
- ClinicalTrials.gov ID
- NCT01549145
- Acronym / sponsor ID
- EST-01-IL
- Conditions
- Tinnitus
- Keywords
- Severe, Ongoing, Unilateral, present for more than 6 months
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- EstimME Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 9 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NIMBUS multifunctional stimulator | Experimental | Device: Nimbus Multifunctional StimulatorA Multifunctional Stimulator (Nimbus by Newmedic, Hemodia) for clinical use. The stimulator is also dedicated for Electrical Promontory Stimulation (EPS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nimbus Multifunctional StimulatorA Multifunctional Stimulator (Nimbus by Newmedic, Hemodia) for clinical use. The stimulator is also dedicated for Electrical Promontory Stimulation (EPS) | Device | NIMBUS multifunctional stimulator |
Primary outcome
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).
1 secondary outcome
Safety
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nimbus Multifunctional Stimulator in people with Tinnitus, run by EstimME Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2012.