Clinical trial · Interventional
Sub-chronic Neurostimulation Delivered in the Middle Ear for Tinnitus Suppression
NCT01549145CI-TRIAL-00007907completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Tinnitus | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nimbus Multifunctional Stimulator | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- NIMBUS multifunctional stimulator
- description
- A Multifunctional Stimulator (Nimbus by Newmedic, Hemodia) for clinical use. The stimulator is also dedicated for Electrical Promontory Stimulation (EPS)
- interventionNames
- Device: Nimbus Multifunctional Stimulator
Primary outcomes (1)
- measure
- Efficacy
- timeFrame
- 2 months
- 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).
Secondary outcomes (1)
- measure
- Safety
- timeFrame
- 2 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.